One of the big TwIqbal issues in PMA medical device preemption cases is whether plaintiffs can plead “parallel” claims based on allegations that defendants violated vague FDA regulations (typically involving Current Good Manufacturing Practices, or “CGMPs”) that could be interpreted in more than one way.  Those courts that are “hawkish” on preemption (as are we), led by the Fourth Circuit in Walker v. Medtronic, Inc., 670 F.3d 569, 580 (4th Cir. 2012), do not allow parallel claims based on vague regulations due to the inherent conflict that plaintiffs will interpret such regulations more strictly – and thus “differently” – than the FDA.  Other, less strict courts, exemplified by Bausch v. Stryker Corp., 630 F.3d 546, 554-55 (7th Cir. 2010), cut plaintiffs a break, at least at the pleadings stage, holding that “concrete” regulations are not necessary for parallel claims, and that actually conflicting claims can be weeded out later – “later” meaning after our clients have run up large legal bills for discovery expenses.

For purposes of this post, we assume we’re in one of those benighted courts that let plaintiffs get away with alleging purported violations of vague regulations.  Then what?

We think that this type of claim – based on non-specific regulations − remains of the nuisance variety, with its “value” derived solely from the litigation expense that plaintiffs can impose on our clients.  It’s inherently a preempted claim, because once all is said and done and the plaintiff’s expert has to say exactly what our side did wrong, s/he can’t do so without taking away choices that such regulations give to our clients.  The key phrase for preemption purposes remains “different from or in addition to,” and ultimately violation claims based on vague FDA regulations almost always devolve into a scripted exchange along these lines:

Plaintiff:  “Regulation X requires that you have practices and procedures covering this aspect of your device.

Defendant: “That’s right, and we did.”

Plaintiff:  “But if your practices and procedures had provided for A, you would have discovered the critical problem with your device, fixed it, and I wouldn’t have been injured.”

Defendant:  “Regulation X also allowed us to do B.  That’s what we did, and that was good enough for the FDA.”

Plaintiff.  “But it’s not good enough for me.  Under Regulation X, my expert will say you should have done A, and if you had, I wouldn’t have been hurt.”

At this point, the gong should sound, and the hook of preemption emerge to pull the plaintiff offstage.  Plaintiff has crossed the “different from and in addition to” line.  Vague regulations are vague for a purpose – to provide those being regulated with discretion in how to comply.  They are vague because they intend to allow more than one means of compliance.

The law is clear in PMA cases that a legal theory that deprives a defendant of discretion provided for under FDA regulations and replaces that discretion with mandatory steps dictated by the plaintiff (which, of course, the defendant will not have taken) is preempted.  This kind of claim first came to judicial attention in warning cases.  To avoid preemption, device plaintiffs erroneously tried to rely on Wyeth v. Levine, 555 U.S. 555 (2009), an implied preemption drug case, in opposition to “different from or in addition to” express preemption under the Medical Device Amendments.  In the leading case, the Seventh Circuit (home of Bausch), rejected the analogy.  A state post-sale duty to warn was mandatory, whereas Levine’s CBE process permitted unilateral strengthening of warnings (enough to defeat implied impossibility preemption), but did not mandate that the manufacturer must make such changes.  That was fatal under §360k’s express language.

Where a federal requirement permits a course of conduct and the state makes it obligatory, the state’s requirement is in addition to the federal requirement and thus is preempted.  Where a federal requirement permits a course of conduct and the state makes it obligatory, the state’s requirement is in addition to the federal requirement and thus is preempted.

McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005) (emphasis added).

Another appellate court, this one in Indiana, agreed.  A claim that the defendant had a common-law duty to add warnings, where CBE regulations concerning devices allowed such changes, but did not order them to be made, was preempted by §360k(a):

[Plaintiffs] contend that [defendant] should be liable for its failure to add warnings that are permitted, but not required, by federal law.  We cannot imagine a plainer example of an attempt to impose a standard of care in addition to the FDA’s specific federal requirements.

McGookin v. Guidant Corp., 942 N.E.2d 831, 838 (Ind. App. 2011).  Other cases finding preemption of post-sale duty to warn claims asserting a mandatory state-law requirement to change a warning through the CBE process are:  Scanlon v. Medtronic Sofamor Danek USA Inc., ___ F. Supp.2d ___, 2014 WL 3737501 *6 & n.10 (D. Del. July 28, 2014); Dunbar v. Medtronic, Inc., 2014 WL 3056026, at *4 (C.D. Cal. June 25, 2014); Comella v. Smith & Nephew, Inc., 2013 WL 6504427, at *2 (N.D. Ill. Dec. 11, 2013) (preemption because “[w]hile the federal requirement permits Defendants to provide interim supplemental warnings pending approval by the FDA, it does not require it”); Kashani-Matts v. Medtronic, Inc., 2013 WL 6147032, at *4 (C.D. Cal. Nov. 22, 2013); Gelber v. Stryker Corp., 788 F. Supp.2d 145, 161 (S.D.N.Y. 2011); Cenac v. Hubbell, 2010 WL 4174573, at *6 (E.D. La. Oct. 21, 2010); Heisner v. Genzyme Corp., 2010 WL 894054, at *3 (N.D. Ill. March 8, 2010); Riley v. Cordis Corp., 625 F. Supp. 2d 769, 783 (D. Minn. 2009) (“a failure-to-warn claim cannot parallel §814.39(d) [the device CBE regulation] because §814.39(d) merely permits a device manufacturer to make a temporary change to a label whereas a successful failure-to-warn claim would require such a change”) (emphasis original).

The principle extends well beyond CBE-based warning claims.  Even appellate decisions that, on the whole, are not favorable to preemption recognize that claims taking away administratively provided discretion “add to” the FDA regulatory scheme and are thus preempted.  Heck, even Stengel conceded preemption in this situation.  Stengel v. Medtronic Inc., 704 F.3d 1224, 1234 (9th Cir. 2013) (en banc concurring opinion) (quoting McMullen).  Thus in Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012), the court pointed out that, “if the plaintiff challenges the suitability of the precise processes or procedures chosen by the maker, and approved by the FDA, . . . such a claim could not proceed.”  Id. at 512; accord id. at 513 (claim that the defendant should have used “some other method . . .altogether” from what the FDA permitted “would not be allowed, as it would ‘add to’ the regulatory requirements”).

Trial court cases offer examples of claims that are preempted where plaintiffs have attempted to convert discretionary options into mandatory obligations.  In In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D. Minn. 2009), aff’d, 623 F.3d 1200 (8th Cir. 2010), the plaintiffs argued that the defendants should have used other “methods” of welding besides those the defendant chose under a “regulation [that] covers a broad spectrum of devices and production processes, [and] it allows some leeway in the details.”  Id. at 1157.  That regulatory “leeway” preempted the plaintiffs’ claims that the defendant should have done X rather than Y, when the regulation allowed either.

The CGMPs and QSR [quality system regulations] require manufacturers to develop their own quality-system controls to ensure that medical devices are safe and effective for their intended use, and they are inherently flexible.

Id.  This discretionary aspect yielded preemption because there was no violation where the regulation allowed the defendant to do either what it did or alternatively what the plaintiffs wanted:

The flexibility inherent in the CGMPs and QSR demonstrates why Plaintiffs’ manufacturing-defect claims are not “parallel.”  Plaintiffs allege that [defendant’s] welding techniques were “defective,” but they have not pleaded how that welding technique violated the CGMPs or QSR.  This is likely because the CGMPs and QSR do not provide such a fine level of detail.

Id. at 1158.  The Eighth Circuit affirmed, quoting McMullen, because “[e]ven if federal law allowed” the defendant to do what plaintiffs demanded, “any state law imposing an additional requirement is preempted.”  In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200, 1205 (8th Cir. 2010) (emphasis original).

The state-court cognate of the Sprint Fidelis litigation likewise concluded that the CGMPs plaintiffs claimed were violated had too “inherent” flexibility not to be “different from or in addition to” mandatory state-law tort duties:

Given the flexibility inherent in this system, Plaintiffs cannot show that [defendant’s] chosen welding techniques violated the CGMPs and QSRs; such claims are not parallel claims because they are not predicated upon a violation of a federal requirement. . . .  [T]he fact that the road chosen by a device manufacturer may be different in degree than that thought to be appropriate by a regulator does not mean that it is wrong, or in violation of the regulations.  The [CGMP] regulations do not prescribe each particular step required of a manufacturer] in order for it to comply with these regulations.

In re Medtronic Sprint Fidelis Lead Products Liability State Court Litigation, 2009 WL 3417867, at *18 (Minn. Dist. Oct. 20, 2009) (citations and quotation marks omitted).

Similarly, claims of violations of “CGMPs [that] impose only administrative standards or flexible guidelines rather than mandate manufacturing requirements” were preempted in Eggerling v. Advanced Bionics, L.L.C., 958 F. Supp.2d 1029 (N.D. Iowa 2013).  Because these regulations imposed only “general requirements,” any particular violation claim necessarily crossed the statutory line for preemption:

[A]ttempting to define the general requirements in CGMPs in the device-specific manner required for state tort liability to attach would necessarily impose obligations “different from, or in addition to, any requirement applicable under [the MDA] to the device.”

Id. at 1037 (quoting §360k(a)).

In Cenac, plaintiff claimed (in addition to warnings) that, to comply with a CGMP, the defendant had to do particular things to prevent build-up of a device’s drug component due to insufficient propellant.  The claim was preempted because that regulation “imposes no specific requirements” beyond generally “requir[ing] manufacturers to develop quality control processes, [while] leav[ing] the specific provisions of such processes to the discretion of the manufacturer.”  Id. at *4-5.

Recall claims have also been preempted where they violate the distinction between mandatory state-law duties (assuming, contrary to overwhelming precedent, that such duties exist) and permissive FDA regulations concerning device recalls.  In Franklin v. Medtronic, Inc., 2010 WL 2543579 (Mag. D. Colo. May 12, 2010), adopted, 2010 WL 2543570 (D. Colo. June 22, 2010), the plaintiff’s attempt to base a parallel claim on a voluntary recall regulation failed:

[R]ecall is a voluntary remedial measure to be undertaken on a firm’s own volition.  Thus, because FDA regulations do not require a firm to recall a product other than on a voluntary basis, a finding that Defendant was negligent for failing to recall the . . . Device would establish requirements that are different from, or in addition to, federal requirements.

2010 WL 2543579, at *6 (citations and quotation marks omitted).

Slightly farther afield, another preempted variant of the mandatory/voluntary distinction is a claim that would extend a “mandatory” duty beyond the limited number of persons to whom that duty is owed.  That looming obstacle was why the Stengel concurrence quoted McMullen − the mandatory duty to report adverse incidents to the FDA was owed to the FDA only.  Stengel chose to kick the can down the road, observing only that plaintiffs pursuing failure-to-report claims would “face a causation hurdle” because the plaintiff could not equate failure to report to the FDA with failure to warn physicians.  704 F.3d at 1234.  The court in Pinsonneault v. St. Jude Medical, Inc., 953 F. Supp. 2d 1006 (D. Minn. 2013), found the same point preemptive, because that plaintiff went further than Stengel and actually argued that mandatory reporting to the FDA was “the same as warning a physician.”  Id. at 1015.  It isn’t.  Extending a mandatory duty beyond its scope in the FDA regulatory scheme is expressly preempted:

[P]laintiffs’ failure-to-warn claims are expressly preempted. . . .  [I]f the Court were to apply the duty to warn articulated in [state law] in relation to warning end-users (in this case doctors or patients), as opposed to third parties such as the FDA, it would be mandating a requirement that is different from or in addition to, any requirement applicable under the FDCA. . . .  Such a state law claim would necessarily imply that a warning provided by an MDR [medical device report] would automatically reach a physician and then reach affected patients.  However, as stated above, under the FDA regulatory scheme, MDRs that are submitted by a manufacturer to the FDA are not automatically made public.

953 F. Supp.2d at 1015-16.  The only mandatory reporting required is to the FDA.  Anything beyond that is permissive; subject to the discretion of the FDA to make such reports public, and nothing mandates notifying physicians of adverse event reports whether or not the FDA chooses to make them public.  See Hawkins v. Medtronic, Inc., 2014 WL 346622, at *14-15 (E.D. Cal. Jan. 30, 2014) (relying on Stengel concurrence; “affirmative” state-law warning claim not equivalent to federal duty to “refrain from” particular statements).

Thus, whether or not a court allows a “parallel” violation claim based on a vague CGMP or other FDA regulation to survive TwIqbal shouldn’t change the ultimate preemption outcome.  Avoiding TwIqbal only runs up litigation costs.  A vague FDA regulation is vague for a reason – to give regulated manufacturers discretion to pick the process they think is appropriate.  If the FDA takes a different view, it has enforcement powers.  For preemption purposes, however, the discretion inherent in a vague regulation is the antithesis of a mandatory state common-law duty to do this or that, and eventually a plaintiff has to state what “this or that” is.  At that point preemption should be a foregone conclusion, because whatever the plaintiff’s regulatory expert says is going to be “different from or in addition to” that vague FDA regulation.