Law

We intend to rectify that today, laying out the implied impossibility preemption argument in some detail, but we do so with this bolded and all caps warning (which we would box if we knew how):
 

DO NOT RAISE THIS ARGUMENT EXCEPT IN CASES WHERE YOU BELIEVE THIS NOVEL DEFENSE-SIDE ARGUMENT WILL RECEIVE FAIR CONSIDERATION AND BEARS A COLORABLE CHANCE OF SUCCESS.

As we’ve said before, strange things seem to happen in product liability cases involving preemption, and usually that’s not good for our side.  If you are not before a good judge, this argument will likely be a waste of your time, and your client’s money, while making bad precedent for the rest of us.

The Mensing/Bartlett implied impossibility preemption argument doesn’t apply to all claims involving §510(k) devices.  Unfortunately, the good guys lost the broader express preemption arguments almost twenty years ago in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).  Lohr, however, was solely an express preemption case.  The surviving implied preemption argument we envision lies primarily against design defect claims, because those claims inherently conflict with the FDA’s regulatory scheme in the same way that the warning and design claims did with a different regulatory scheme in Mensing/Bartlett.  This argument can also apply to all medical device design claims, but we’re focusing on the §510(k)s because PMA devices are already protected against design claims by express preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  Should a PMA design claim somehow slip through the Riegel cracks, the implied preemption argument we’re making here could serve as a fall-back – but our warning about judges does, too.

We start with the proposition that the FDA’s device regulations require that any “major modification” of a device’s design must be submitted to the FDA before that change is made.  The relevant FDA regulation requires that device manufacturers “must submit a premarket notification submission to the Food and Drug Administration at least 90 days before” beginning to sell the modified device:

Three Supreme Court cases supply the rationale for extending implied preemption, specifically conflict preemption by reason of impossibility, to §510(k) medical devices.  The first case is our good friend Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  Buckman involved a §510(k)/Class II medical device.  Id. at 346 (describing device’s regulatory pedigree).  Buckman holds that, notwithstanding the absence of express preemption applicable to §510(k) medical devices under Lohr, implied preemption nonetheless bars tort claims that conflict with the FDA regulatory scheme.  That the device in question wasn’t covered by express preemption in no way limits the applicability of implied preemption:

Buckman alone thus dispatches the superficial discussion in Pinnacle Hip, which was that “[b]ecause this case involves a medical device and not prescription drugs, [defendant’s] argument is foreclosed by the Supreme Court’s decision in [Lohr].”  2014 WL 3557392, at *10.  Buckman demonstrates that implied preemption can apply to §510(k) devices, Lohr or no Lohr.  Whether or not the FDA “passed on the original design” of a §510(k) device, id. at *11, manufacturers can’t change that design in any way that affects its safety without going back to the FDA under §807.81(a)(3).

After Mensing that matters.

In Mensing, the Court considered implied conflict preemption in a warning-related case involving generic drugs.  As with design changes in medical devices, a manufacturer of generic drugs cannot take “unilateral” action – immediate label changes − that the plaintiff’s asserted state-law product liability duty demanded.  Id. at 2575.  The applicable FDA regulation in Mensing required prior FDA submission and review of the sort of changes that the plaintiff contended were needed in the defendant’s warnings.  Id. (“changes unilaterally made to strengthen a generic drug’s warning label would violate the [applicable] statutes and regulations”).  Because the FDA’s regulatory scheme precluded the very immediate action that plaintiff’s state-law tort duties required, it was impossible for the defendant in Mensing simultaneously to comply with state law without running afoul of the FDCA’s pre-approval requirement.  Federal law preempts state law where it is “not lawful under federal law . . . to do what state law required.”  Id. at 2577.

Critically, Mensing’s “independence”  rationale was extended to design defect claims in Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466  (2013).  Bartlett found it equally “impossible” to comply with an immediate state-law duty to change a design where the FDCA required prior FDA submission and review.  In Bartlett, the defendant “was unable to change [the product’s] composition as a matter of both federal law and basic chemistry.”  Id. at 2470.  Specifically, “[o]nce a drug − whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications.’”  Id. at 2471 (quoting 21 C.F.R. §314.70(b)(2)(i)) (emphasis original).  In Bartlett, the Court facially intended that its reasoning not be limited to generic drugs.  Why else would it have introduced a mention of “brand-name” drugs in its discussion?

The same conflict found in Mensing, between an immediate state-law duty to change a product’s design and the FDCA’s requirement of prior FDA review of such changes, also resulted in impossibility preemption in Bartlett.  The manufacturer could not “independently chang[e]” its product, “[t]hus, federal law prohibited [defendant] from taking the remedial action required to avoid liability under [state] law.”  Bartlett, 133 S. Ct. at 2476.  “When federal law forbids an action that state law requires, the state law without effect.  Id. at 2477 (citation and quotation marks omitted).

Nor, under Bartlett, can plaintiffs argue that state law requires removal of a federally approved product from the market.  When the FDA allows a product to be marketed, state law cannot prohibit that marketing.

At this point, it would be best for a defendant making this argument to scour the law of the relevant jurisdiction to look for any preemption cases by local state or federal courts that, like Mensing/Bartlett, distinguish between unpreempted “unilateral”/“independent” action and preemption-protected actions requiring prior federal review.  These cases need not be device (or even FDCA) cases, although the closer they are to §510(k) medical devices, the better.  What matters is local precedential support for the proposition that prior government approval makes a preemptive difference.  We know that prior approval was cited in support of preemption in some PMA medical device cases prior to the issue being settled by the Supreme Court in Riegel.

One such case was Riegel itself, before being appealed to the Supreme Court.  The Second Circuit pointed out in Riegel that “a PMA supplement must be submitted for review and approval by the FDA before any change is made that affects the safety or effectiveness of the device,” whereas a “§510(k) supplemental submission is required only where the device is about to be significantly changed or modified in design.”  Riegel v. Medtronic, Inc., 451 F.3d 104, 112-13 (2d Cir. 2006) (citing and quoting §807.81(a)(3)), aff’d, 552 U.S. 312 (2008).  Prior approval meant preemption, because a jury verdict that a medical device’s “design did not comport with the duty of due care” . . . would clearly differ” . . . from the FDA’s prohibition against making any modifications affecting the device’s safety and effectiveness without first obtaining FDA approval.”  Id. at 122 (emphasis added).

Mensing/Bartlett implied impossibility preemption is already being extended to design defect cases involving innovator drugs, further indication that this argument is in no way unique to generic drugs.  Implied preemption is not dependent on statutory preemption clauses, thus nothing limits its independent action test to generic drugs.  Several courts have so held:

Under Buckman, Mensing, Bartlett, and the other cases cited in this post, design claims against §510(k) medical devices should preempted by the manufacturer’s obligation under §807.81(a)(3) to seek prior FDA blessing of design changes that affect device safety.  The Lohr express preemption decision in no way limits the operation of implied preemption, as Buckman and several other Supreme Court decisions have held.  Under Mensing and Bartlett, impossibility preemption exists anywhere that a federally-regulated defendant cannot “independently do under federal law what state law requires of it,” 131 S. Ct. at 2579, so implied impossibility preemption should bar design defect claims against §510(k)-cleared medical devices, as well as against generic and innovator drugs.  In every instance, FDA regulations mandate that design changes having a significant effect on product safety be passed on by the FDA before the modified product can be marketed.

So there you have it – the implied preemption argument against design defect claims involving §510(k) devices.  As far as we know, this argument has only rarely been made in any form, and it has yet to succeed in the §510(k) context.  But we firmly believe that it’s right, and it should win under current United States Supreme Court precedent.  What we need now are judges willing to give this argument a fair hearing.