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We have alluded on a couple of occasions to the likelihood that the recent generic drug implied impossibility preemption decisions in PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), can provide the basis for using this type of preemption in certain cases involving medical devices cleared under the FDCA’s §510(k) “substantial equivalence” process.  These are mostly Class II devices, but also encompass some falling into Class III (go here for more on that).  We’ve also noticed that, in the two years since Bartlett added the most significant piece to this puzzle, there’s hardly any case law on point – only one decision, In re DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, 2014 WL 3557392, at *10-11 (N.D. Tex. July 18, 2014), which is both superficial and adverse.

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):


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:

that the person currently has in commercial distribution. . . but that is about to be significantly changed or modified in design. . . .  The following constitute significant changes or modifications that require a premarket notification:

(I) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, [or] chemical composition. . . .

21 C.F.R §807.81(a)(3) (“When a Premarket Notification Submission Is Required”).  Pretty much by definition, all device-related changes that could have any causal effect in a product liability case qualify as “major modifications” under this regulation, and therefore require FDA pre-submission. To prevent injury in a product liability action, a proposed design alternative “could” – indeed, must – “significantly affect the safety or effectiveness” of the device in question.

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:
To the extent [plaintiff] posits that anything other than our ordinary pre-emption principles apply under these circumstances, that contention must fail [because] . . . neither an express pre-emption provision nor a saving clause bars the ordinary working of conflict pre-emption principles.

Id. at 352 (quoting Geier v. American Honda Motor Co., 529 U.S. 861, 869 (2000)).  Thus, Lohr was no obstacle to implied preemption of a “fraud on the FDA” claim against the manufacturer of a §510(k) device.  Id. at 353 (“this sort of litigation would exert an extraneous pull on the scheme established by Congress”).

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.

If the Manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law. . . .  Thus, it was impossible for the Manufacturers to comply with both their state-law duty to change te label and their federal law duty to keep the label the same.

*          *          *          *

The question for “impossibility” is whether the private party could independently do under federal law what state law requires of it.

Id. at 2578-79 (emphasis added).  This “independent” action requirement is the key to implied impossibility preemption after Mensing.

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.

We reject this “stop-selling” rationale as incompatible with our pre-emption jurisprudence. Our pre-emption cases presume that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether in order to avoid liability.

Id. at 2479.

While not establishing a “safe harbor,” impossibility preemption,

does prevent them [regulated manufacturers] from taking certain remedial measures.  Where state law imposes a duty to take such remedial measures, it “actual[ly] conflict[s]with federal law” by making it “impossible for a private party to comply with both state and federal requirements.”
Id. (quoting Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995)).  That citation to Myrick – which is not an FDCA case at all – further demonstrates that implied impossibility preemption under Mensing/Bartlett is not limited to generic drugs, but rather extends to any situation, such as design changes, where regulatory procedures under federal law are inconsistent with the immediate demands of state tort duties.

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).

In fact, it is unclear what a manufacturer . . . would do when faced with such a jury verdict on a plaintiff’s common law claims, given that the manufacturer would nonetheless be unable to make any modifications affecting the device’s safety and effectiveness without obtaining further FDA approval.

Id. (emphasis added).  We haven’t made a comprehensive search, but the following preemption cases quote the above-highlighted language from the Second Circuit’s Riegel decision: Troutman v. Curtis, 143 P.3d 74, 86 (Kan. App. 2006), aff’d on other grounds, 185 P.3d 930 (Kan. 2008); Hernandez v. Stryker Corp., 2014 WL 7044171, at *7 (W.D. Wash. Dec. 11, 2014); Gelber v. Stryker Corp., 752 F. Supp.2d 328, 331 (S.D.N.Y. 2010); Parker v. Stryker Corp., 584 F. Supp.2d 1298, 1303 (D. Colo. 2008); In re Medtronic, Inc., Implantable Defibrillators Litigation, 465 F. Supp.2d 886, 893 (D. Minn. 2006).  Note, however, that these cases are PMA medical device cases, not §510(k), so they are by no means conclusive.  They are simply further support for the general proposition, recognized in Mensing/Bartlett, that FDA pre-review is a reason supporting preemption.  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:

Although [plaintiffs] assert that the preemption is applicable to only generic drugs, the language in Bartlett . . . is not so restrictive.  The Supreme Court specifically stated that “[o]nce a drug – whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes. . . .  This language establishes that the Supreme Court did not limit its holding in Bartlett to generic drugs.

Yates v. Ortho-McNeil Pharmaceutical, Inc., 76 F. Supp.3d 680, 686-88 (N.D. Ohio 2015). Accord Shah v. Forest Laboratories, Inc., 2015 WL 3396813, at *5 (N.D. Ill. May 26, 2015); Booker v. Johnson & Johnson, 54 F. Supp.3d 868, 874-75 (N.D. Ohio 2014); Amos v. Biogen Idec, Inc., 28 F. Supp.3d 164, 168-69 (W.D.N.Y. 2014).

Under Buckman, Mensing, Bartlett, and the other cases cited in this post, design claims against §510(k) medical devices should be 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.