Friday, August 17, 2012

Preemption Amongst the Palmettos

There have been two recent state supreme court decisions concerning PMA medical device preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  One of them, Cornett v. Johnson & Johnson, ___ A.3d ___, 2012 WL 321094 (N.J. Aug. 9, 2012), will be the subject of Monday’s post, as our Dechert colleagues are from New Jersey and wanted to write about that one.


The other one, Weston v. Kim’s Dollar Store, ___ S.E.2d ___, 2012 WL 3205150 (S.C. Aug. 8, 2012), comes from South Carolina and involves one of the more unusual PMA products − non-corrective, UV light protective contact lenses.  That’s right − some decorative, colored contact lenses are PMA approved (due to UV protection), and thus protected by Riegel preemption.

The plaintiff in Weston didn’t seem to believe it either.  Almost all of her argument in the intermediate appellate court, and some of her argument in the high court, was devoted to claiming that the product was really “cosmetic” and thus didn’t deserve to be subject to pre-market approval.  Weston, 2012 WL 3205150, at *2-3.  The court wisely refused to let state-court plaintiffs attack whether a product should be subject to FDA PMA requirement:

There is no dispute that the lenses [plaintiff] purchased were UV lenses.  [Defendant] received a letter from the FDA approving PMA supplement . . ., which “requested approval for incorporating an ultra-violet absorber” into [the relevant] lenses.  Additionally, the FDA approved a supplemental PMA in 1999. . . .  Thus, because of the presence of the UV-absorbing component, we find that these lenses were subject to device-specific FDA requirements.  The record establishes as a matter of law that these lenses are covered by PMAs . . . therefore, express preemption is triggered.

Weston, 2012 WL 3205150, at *3.

The plaintiff in Weston also complained that the defendant “knew its [contact] lenses were frequently sold without a prescription and by unauthorized sellers, yet . . . failed to take steps to ensure customers received lenses by prescription only.”  Id. at *1.  Interesting claim − one we don’t see every day.  However, in the context of this PMA device, the plaintiff offered no evidence of any FDA requirement that obligated a device manufacturer to police its supply chain to ensure that the “prescription-only” sales limitation was enforced.  “Any claim that imposes requirements different from or additional to those set forth in the PMA is expressly preempted.”  Id. at *4.

The court in Weston did hold that a manufacturing-based claim (conceded by the defendant to be unpreempted) should survive, along with any “any claim that parallels applicable federal requirements.”  Id.  Unfortunately, that was as far as the court thought it could go − “due to the lack of specificity in Petitioner's complaint and the trial court's order granting summary judgment, we regret we cannot be more specific in delineating which claims survive the partial grant of summary judgment.”  Id.

That is unfortunate.  The original order granting summary judgment on preemption grounds was entered way back in 2006 − well before RiegelSee Weston v. Kim’s Dollar Store, 2006 WL 4911566 (S.C.C.P. Nov. 28, 2006).  We sure hope it doesn’t take the plaintiff another six years to litigate whether she has any viable parallel claims beyond the one conceded by the defendant (not that we think there are any).

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