We confess that we read McAdams v. Medtronic, Inc., 2010 WL 3909958 (S.D. Tex. Sept. 29, 2010), a while ago, but we weren’t sure what to make of it.  On the one hand, there’s an interesting idea in there.  On the other hand, it didn’t win in McAdams. We still don’t know if it will win or not, but after thinking about it, we think it’s worthy of our readers’ consideration.

McAdams is another shot at one of defense counsel’s holy grails:  to use the presence of an issue implicating federal law – but something less than a federal cause of action – as a basis of obtaining subject matter jurisdiction in federal court.  The general principle is stated in Grable & Sons Metal Products, Inc. v. Darue Engineering. & Manufacturing, 545 U.S. 308 (2005).  Removal is appropriate where a state court claim “necessarily raise[s] a stated federal issue [that is] actually disputed and substantial, which a federal forum may entertain without disturbing any congressionally approved balance of federal and state judicial responsibilities.”  Id. at 312.

Satisfying all of the requirements is hard – and it’s intended to be, since one of the factors is that no defendant’s bright idea should be able to upset the federal-state balance by moving lots of cases into federal court.  Empire Healthchoice Assurance, Inc. v. McVeigh, 547 U.S. 677, 699-700 (2006) (Grable only allows removal of a “small and special” set of cases).

What went on in McAdams has to do with the impact of medical device preemption after Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  Basically, most courts have preempted just about everything except “parallel” claims that, in effect, allege violations of the Medical Device Amendments.  Thus, one effect of Riegel is to place FDA compliance/violation issues front and center in any case involving a PMA medical device.

The defense syllogism:  FDA compliance = embedded federal issue under Grable.

The first part of the test is does the plaintiff’s “right to relief necessarily depends on resolution of a substantial question of federal law”?  Well, if there’s nothing else that survives preemption, the “necessarily depends on” part of the test is satisfied pretty easily.  As the court in McAdams observed, “it appears that plaintiffs cannot prove their claims absent establishing that [the defendant] failed to meet FDA standards.”  2010 WL 3909958, at *3.

That’s right. The only way a violation claim survives preemption under Riegel is where it’s neither “different from” nor “in addition to” the FDA standard.

How about the “substantial question”?  Here, the court stated that “[w]hether [defendant] complied with federal standards with respect to its [device] is important to [defendant] (and to plaintiffs), but there is no broader issue of federal law implicated.” Why? The main reason the court gave is that “the MDA has specifically been interpreted to permit parallel state court claims,” which the court viewed as “indication that the federal interest in this matter is not substantial.”  McAdams, 2010 WL 3909958, at *4 (citing Riegel).

That argument, we think, is fixable.  First of all, it’s not exactly accurate.  Riegel didn’t hold anything about parallel violation claims.  All such claims in Riegel had been waived by the plaintiff’s failure to preserve.  The Court made an observation based upon such claims surviving in Lohr.  552 U.S. at 330 (“Although [plaintiff’s] now argue that their lawsuit raises parallel claims, they made no such contention in . . . the Second Circuit. . . . We decline to address that argument in the first instance here.”).

Two, four, six, eight … time to re-substantiate.  (Apologies to Tom Lehrer).

So maybe next time we take the position that the plaintiffs can’t in fact bring parallel claims because they are nothing more than a prohibited private right of action under the MDAs/FDCA.  Buckman pretty much says that.  Do we actually win that argument?  At this point probably not short of the Supreme Court – but at the removal stage that’s not the point.  The point is we’re no longer just arguing about this plaintiff or this device. We’re arguing that federal law, 21 U.S.C. §337(a), doesn’t allow these claims at all.

That argument, win or lose, is considerably more “substantial” under the Grable test.  It might work to keep a case in federal court.  Whether a court agrees with us or not about the dictum in Riegel, the issue is significant to more than the parties.

On to the last Grable prong.

Will allowing removal upset the federal/state balance?  The McAdams decision says it would:

The Supreme Court has already declined to open the federal courts up to medical torts in the context of Merrell Dow [Pharmaceuticals, Inc. v. Thompson, 478 U.S. 804 (1986)], and this case is not distinguishable on any relevant basis.  Indeed, allowing every state law tort claim that involves a medical device to be removed to federal court would result in precisely the type of “potentially enormous shift” of cases from the state to federal courts that the Supreme Court refused to permit in Merrell Dow.

McAdams, 2010 WL 3909958, at *5.

Either the court didn’t understand, or didn’t want to understand, the narrow scope of a post-Riegel parallel violation claim.

“[E]very state law tort claim that involves a medical device”?

We wish.

Our side lost that issue in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).  Riegel is quite clear that the only type of device entitled to preemption is one that’s pre-market approved by the FDA.  552 U.S. at 317-20.  Most devices aren’t PMA-approved.  Rather, they’re cleared as “substantially equivalent” under the process held not preemptive in Lohr.  The Second Circuit addressed that point in Riegel:  “In other words . . . approximately ninety-nine percent of such devices went through the § 510(k) process and only one percent went through the PMA process.”  Riegel v. Medtronic, Inc., 451 F.3d 104, 112 (2d Cir. 2006), aff’d, 552 U.S. 312 (2008).

We aren’t talking about “every” device here – not even close.

The vast majority of even Class III devices aren’t PMA.

Moreover, not every PMA device products case can raise a plausible parallel violation claim.  There has to be a real violation, not just some vague allegation that the defendant might have violated something.  Lots of decisions in our medical device preemption scorecard hold that the claimed violation must be:  (1) of a particular, pleaded regulation, (2) that is causally related to the device that allegedly injured the plaintiff.  In practice that means that, if the FDA hasn’t already taken enforcement action, there’s no such animal.  Even most violation claims don’t make it past TwIqbal.

So McAdams way overstates the effect of a holding that a post-Riegel parallel violation claims is an embedded federal question that supports subject-matter jurisdiction under Grable.  This isn’t anywhere near what the Supreme Court had in front of it in Thompson.  The defendant’s argument in Thompson could have put virtually every drug product liability case in federal court.  The number of PMA devices is infinitesimally smaller, and the number of cases where there’s a viable parallel violation claim is smaller still.  A sympathetic judge could easily distinguish what the court in McAdams chose not to.

Does that mean that the centrality of parallel violation claims in post-Riegel PMA device cases puts them on a fast track to federal court?

We wouldn’t say that, but we think that tying Grable to “parallel violation” claims, where such claims are effectively the only thing that a plaintiff has left after Riegel, is an intriguing idea.  The proposition didn’t win in McAdams, but we don’t see anything in that decision’s reasoning that looks like an insurmountable obstacle.