When it comes to design defect claims and FDA pre-market approved (“PMA”) medical devices, “preemption” is our reflexive reaction. That’s entirely reasonable, given the many decisions that preempt state-law design-related claims since Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  We collect then all here.

Nevertheless, there are some judges, particularly (but not all) in state court, who react negatively to the very concept of preemption.  Thus, a word to the wise is not to put all your dismissal eggs in one basket.  One logical alternative argument starts with the same premise as preemption – that “the FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application.”  Riegel, 552 U.S. at 323.

The “almost no deviations” limitation, of course applies to device design.  E.g., Walker v. Medtronic, Inc., 670 F.3d 569, 580 (4th Cir. 2012); Blunt v. Medtronic, Inc., 760 N.W.2d 396, 409 (Wis. 2009); McLaughlin v. Bayer Corp., 172 F. Supp. 3d 804, 810 (E.D. Pa. 2016); Kitchen v. Biomet, Inc., 2014 WL 694226, at *3 (E.D. Ky. Feb. 21, 2014); Miller v. DePuy Spine, Inc., 638 F. Supp. 2d 1226, 1229 (D. Nev. 2009).

Which brings us to Restatement (Second) of Torts §402A, comment k (1965), “which insulates from liability manufacturers of unavoidably unsafe products that are properly prepared and accompanied by an adequate warning.”  Rodriguez v. Stryker Corp., 680 F.3d 568, 575 (6th Cir. 2012) (applying Tennessee law).  Putting aside the separate (albeit important) issue whether comment k applies to prescription medical products generally or only on a case-by-case basis, courts on both sides of that question equate “unavoidably unsafe” with the absence of an alternative design:

[N]umerous state and federal courts ha[ve] interpreted comment k to mean that a product is “unavoidably unsafe” when, given proper manufacture and labeling, no feasible alternative design would reduce the safety risks without compromising the product’s cost and utility.

Bruesewitz v. Wyeth LLC, 562 U.S. 223, 256 (2011) (Breyer, J. concurring) (footnote containing string citation omitted) (emphasis added).  In other words, “a defendant seeking to invoke the [comment k] defense must first show that the product is highly useful and that the danger imposed by the product could not have been avoided through a feasible alternative design.”  Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466, 2487 (2013) (applying New Hampshire law).  To avoid a claim of “unavoidable risk, there must be, at the time of the subject product’s distribution, no feasible alternative design which on balance accomplishes the subject product’s purpose with a lesser risk.”  Toner v. Lederle Laboratories, 732 P.2d 297, 306 (Idaho 1987).  “The purpose of comment k is to protect from strict liability products that cannot be designed more safely.” Grundberg v. Upjohn Co., 813 P.2d 89, 92 (Utah 1991).  Grundberg and Toner don’t agree on much when it comes to comment k, but they agree on the importance of alternative design.

Thus, that a PMA-approved device must be made with “almost no deviations” from its specified design means (in addition to preemption) that there is no legal alternative design that would allow the plaintiff to avoid a manufacturer’s comment k defense.  To use a non-approved alternative design would be illegal – and illegal designs cannot serve as “feasible” alternative designs.  See Lewis v. American Cyanamid Co., 715 A.2d 967, 981 (N.J. 1998} (“plaintiff may not succeed on an alternative design theory that would have required the defendant manufacturer to violate the law”); White v. Wyeth Laboratories, Inc., 533 N.E.2d 748, 753-54 (Ohio 1988) (alternative design not feasible where “it was not possible for [defendant] to have legally marketed a [product] design using [the alternative design] at the time [plaintiff] was inoculated”); Ackley v. Wyeth Laboratories, Inc., 919 F.2d 397, 401 (6th Cir. 1990) (following White; alternative designs did not “exist[]” where it was “indisputable” that “[w]ithout an FDA license to produce another design, [defendant] was legally prohibited from distributing” those designs) (applying Ohio law); Wolfe v. McNeil-PPC, Inc., 773 F. Supp.2d 561, 572 (E.D. Pa. 2011) (when “[t]here exists no FDA-approved alternative form of [the product],” “there is no available alternative design”); Militrano v. Lederle Laboratories, 769 N.Y.S.2d 839, 847-48 (N.Y. Sup. 2003) (where plaintiff proposed a non-FDA-approved alternative, defendant “could not have marketed a reasonable alternative”), aff’d, 810 N.Y.S.2d 506 (N.Y.A.D. 2006); In re Alloderm Litigation, 2015 WL 5022618, at *12 (N.J. Super. Law Div. Aug. 14, 2015 (no feasible alternative where design plaintiff advocated “was not approved by the Food and Drug Administration until” after plaintiffs’ surgeries); Totterdale v. Lederle Laboratories, 2008 WL 972657 (W.Va. Cir. Mar. 19, 2008) (where FDA approval not until after plaintiff’s injury plaintiff did “not provide[] any new material facts to raise a genuine issue as to whether [the product] was avoidably unsafe”).

Thus, in Gross v. Stryker Corp., 858 F. Supp.2d 466 (W.D. Pa. 2012), comment k applied to “a Class III medical device which received FDA approval pursuant to the PMA process.” Id. at 481 (footnote omitted).

Moreover, the inherently rigorous nature of the premarket approval process and the contraindications, warnings, and precautions described in the [device’s] Summary of Safety and Security Data all suggest that [it] is an “unavoidably unsafe” product to which strict liability does not apply.

Id. at 482.  “As a result, the [device] can be considered a prescription medical device that falls within the scope of comment k to § 402A.”  Id.

Similarly, the court employed the non-preemption path of comment k in Aaron v. Medtronic, Inc., 209 F. Supp.3d 994 (S.D. Ohio 2016).  While Ohio (at the relevant time, this has now changed, Ohio Rev. Code Ann. §2307.75(D)) was a case-by-case comment k state, the PMA approved nature of the device, and the constraints the FDA’s approval placed on alternative designs, meant that comment k had to apply:

Defendant argues . . . that [the device’s] classification by the FDA as a Class III medical device inherently means that it is unavoidably unsafe and that Comment K’s prohibition of strict liability claims therefore applies. Defendant’s argument is well taken.  Class III devices . . . are, as relevant here, defined as devices that are “for a use which is of substantial importance in preventing impairment of human health, or…present[] a potential unreasonable risk of illness or injury.”  21 U.S.C. §360c(a)(1)(C)(ii). . . .

[T]here is no alternative design for [the device] that could lawfully be marketed.  “Once a device has received premarket approval, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications…that would affect safety or effectiveness.” There is therefore no basis for an in-depth evidentiary inquiry into alternative designs.

Aaron, 209 F. Supp.3d at 1013-14 (quoting Riegel, 552 U.S. at 319) (other citations omitted).

So while preemption should do the trick with design defect claims involving PMA approved medical devices, courts may sometimes have an easier time with alternative, non-constitutional arguments such as the lack of any legal alternative design under Restatement §402A, comment k.  Consider giving judges this other way to the end result that we all want – dismissal of design defect claims.

As our PMA preemption scorecard makes clear, warning claims are preempted under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), because the preemptive language, “different from or in addition to,” precludes plaintiffs from demanding more or different warnings.  Since warning claims are the bread and butter of prescription medical product liability, plaintiffs will try just about anything to get around that simple fact.

One common plaintiff-side tactic is to relabel failure to warn as “fraud.”  Plaintiffs then argue that “fraud” claims shouldn’t be preempted, either because they are predicated “on a more general obligation[,] the duty not to deceive,” Cipollone v. Liggett Group, Inc., 505 U.S. 504, 528-29 (1992), or because they are a “parallel” claim associated both with that “general” state-law duty and FDA regulations prohibiting “false or misleading” statements.

While sometimes plaintiffs gain some traction with “fraud” claims asserting affirmatively false statements, most failure to warn claims involve omissions.  Thus, plaintiffs are also wont to argue that “fraudulent concealment” or “fraud by omission” claims should also be unpreempted.  Here plaintiffs lose.  Such concealment/omission claims are always at least “in addition to” a PMA device’s FDA-approved labeling.

The key case, Perez v. Nidek Co., 711 F.3d 1109 (9th Cir. 2013), held that not only is a “fraud by omission claim [] expressly preempted” – but “obvious[ly]” so.  Id. at 1118.

The teachings from the Supreme Court cases plus our application of MDA preemption . . . lead to an obvious result:  [plaintiff’s] fraud by omission claim is expressly preempted by § 360k(a).  [T]he [omission] claim here depends on a requirement that is “in addition to” those federal requirements.  [Plaintiff] effectively seeks to write in a new provision to the FDCA: that physicians and medical device companies must affirmatively tell patients when medical devices have not been approved for a certain use. . . .  Just as significant, the alleged missing disclosure . . . “relates to the safety or effectiveness” of the [PMA device].

Id. at 1118-19 (emphasis added).   See Martin v. Medtronic, Inc., 2017 WL 825410, at *7 (E.D. Cal. Feb. 24, 2017) (following Perez; fraudulent concealment claim expressly preempted); Frere v. Medtronic, Inc., 2016 WL 1533524, at *10 (C.D. Cal. April, 6, 2016) (same); Jones v. Medtronic, 89 F. Supp.3d 1035, 1050 (D. Ariz. 2015) (same); Hawkins v. Medtronic, Inc., 2014 WL 346622, at *6 (E.D. Cal. Jan. 30, 2014) (same).

This rationale means that, the “distinction between claims premised on false misrepresentations and those premised on omissions” has been described as “the key dividing line” for preemption purposes.  Schouest v. Medtronic, Inc., 13 F. Supp.3d 692, 701 (S.D. Tex. 2014).

The affirmative misrepresentation/omission distinction is representative of the two types of claims [plaintiff] is asserting: on the one hand, that [defendant] did not do enough, and on the other, that [defendant] did too much.

Id.

In another claim, like Perez and Schouest, alleging failure to warn of risks of off-label use of a PMA device as “fraudulent concealment,” the court held such claims expressly preempted to “to the extent it is based on any alleged omissions or concealments.” Byrnes v. Small, 142 F. Supp.3d 1262, 1269 (M.D. Fla. 2015).

Plaintiffs have not identified any federal requirement to inform the public or to update warning labels regarding the dangers of the off-label use of medical devices.  Therefore, to the extent this claim is premised on [defendant’s] alleged concealment of information . . ., it is expressly preempted, because requiring [defendant] to warn [prescribers] of the dangers of the off-label use of [the device] would clearly be different from, or in addition to, the federal requirements.

Id. (citation, footnote, and quotation marks omitted).

In Sadler v. Advanced Bionics, Inc., 929 F. Supp.2d 670 (W.D. Ky. 2013), state “law for fraudulent omissions . . . requires that the defendant have a duty to disclose information.”  Id. at 683 (citation omitted).

Plaintiffs cite no federal duty to disclose to the public or to patients the omitted information.  Therefore, to the extent Plaintiffs assert that [defendant] was under some state law duty to disclose, this amounts to an additional requirement, which §360k expressly preempts.

Id. at 683-84 (citation and footnote omitted)

In Leonard v. Medtronic, Inc., 2011 WL 3652311 (N.D. Ga. Aug. 9, 2011), the plaintiffs claimed that their concealment allegations were “actually a fraud claim” when faced with a preemption motion.  That dodge went nowhere:

This claim is preempted because it would require [defendant] to give different, additional warnings about the [device’s] safety and effectiveness, which is strictly prohibited without FDA approval. . . .  Plaintiffs’ fraud claim thus necessarily imposes state requirements that are “different from, or in addition to” the federal ones.

Id. at *11 (citation omitted).

Likewise, in Littlebear v. Advanced Bionics, LLC, 896 F. Supp. 2d 1085, 1091 (N.D. Okla. 2012), the plaintiff “d[id] not claim [defendant] made any affirmative misrepresentations” but only that it did not disclose its use of a purportedly non-FDA-approved part.  Id. at 1091.  Since no FDA regulation mandated such a disclosure, the “fraud by nondisclosure [wa]s expressly preempted.”  Similarly, in Purcel v. Advanced Bionics Corp., 2010 WL 2679988 (N.D. Tex. June 30, 2010), plaintiff’s “claims of fraud by nondisclosure . . . impose a requirement in addition to those approved by the FDA — the duty to warn consumers if devices are adulterated − and are therefore preempted.”  Id. at *6. See Burrell v. Bayer Corp., ___ F. Supp.3d ___, 2017 WL 1955333, at *8 (W.D.N.C. May 10, 2017) (fraudulent concealment claims “alleg[ing] misrepresentations [that] are indistinguishable from FDA-approved labeling statements” held preempted); Richardson v. Bayer Healthcare Pharmaceuticals, Inc., 2016 WL 4546369, at *9 (D. Idaho Aug. 30, 2016) (“fraud by concealment claim addresses essentially the same conduct as the failure to warn claim” and is expressly preempted because state “law cannot require stronger duties than the FDA actively requires under the MDA”); Humana Inc. v. Medtronic Sofamor Danek USA, Inc., 133 F. Supp.3d 1068, 1076 n.12 (W.D. Tenn. 2015) (“fraud by omission is expressly preempted under the FDCA”) (quoting Perez, supra); Day v. Howmedica Osteonics Corp., 2015 WL 13469348, at *8 (D. Colo. Dec. 24, 2015) (“because Plaintiffs’ concealment and misrepresentation claims take issue with the labeling and representations made regarding the [device] and the clinical trial of the device, these claims are preempted”); Cline v. Advanced Neuromodulation Systems, Inc., 17 F. Supp.3d 1275, 1288 (N.D. Ga. 2014) (“[t]o the extent Plaintiff’s fraud claim is based on Defendant’s omissions of information regarding known device failures, it is preempted”); Ali v. Allergan USA, Inc., 2012 WL 3692396, at *17 (E.D. Va. Aug. 23, 2012) (“The cause of action for fraud by nondisclosure is also preempted by the MDA because it would impose requirements under [state] law that add to federal requirements on statements [defendant] can make concerning [the device].”); Latimer v. Medtronic, Inc., 2015 WL 5222644, at *8 (Ga. Super. Sept. 4, 2015) (“a fraud by omission claim is expressly preempted . . . because the underlying state-law disclosure requirement would necessarily be different from, or in addition to the requirements applicable” under federal law) (quoting Perez, supra).

The converse is also true. In McLaughlin v. Bayer Corp., 172 F. Supp.3d 804 (E.D. Pa. 2016), the basis for the plaintiffs’ fraudulent concealment claim against the maker of a PMA device was an alleged “duty to disclose” under the FDCA.  Id. at 825.  Because “[t]he Complaint in this case alleges only that federal law and the PMA imposed a duty to speak by requiring [defendant] to disclose certain information,” it was impliedly preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  172 F. Supp.3d at 825 (emphasis original).  Since plaintiffs “do[] not allege that [state] law imposed any duty on [defendant] to disclose the allegedly undisclosed information . . ., the “fraudulent concealment claim, as pled, exists ‘solely by virtue of FDCA requirements,’” and was thus preempted under BuckmanId.  Accord Perez, 711 F.3d at 1119-20 (fraud by omission claim impliedly preempted because premised on defendant’s non-disclosure concerning scope of FDA’s premarket approval); Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166, 1178 (C.D. Cal. 2013) (fraudulent concealment claim impliedly preempted); Bush v. Thoratec Corp., 837 F. Supp.2d 603, 608-09 (E.D. La. 2011) (same).

Since fraudulent concealment/omission claims in PMA device litigation are merely failure to warn claims with a scienter requirement – and scienter is irrelevant to express preemption under §360k – it is only fitting that these claims are preempted for the same fundamental reasons as warning claims.

And it’s the start of another season of too much eating, drinking, shopping, and socializing. Sometimes it feels like a year’s worth cramped into a little over a month. And, for some of us (OK, me), we’re entering this week still a little groggy and foggy. So, we’ll admit to looking for something fairly straightforward and on the shorter side to post about as we clear our heads and shake off the haze. That’s not to say Mitchell v. Boehringer Ingelheim Pharma, Inc., 2017 U.S. Dist. LEXIS 192498 (W.D. Tenn. Nov. 21, 2017) isn’t noteworthy, it’s just not overly complicated. Sometimes that’s what you need to get the ball rolling again.

Plaintiff in Mitchell alleged that she suffered diabetic ketoacidosis (“DKA”) as a result of using the prescription drug Jardiance to treat her type-2 diabetes. Id. at *3. The drug, one of a class of drugs known as SGLT-2 inhibitors, was approved by the FDA in August 2014 and plaintiff began using it in February 2015. In May 2015, the FDA issued a safety alert warning about the risk of DKA with this class of drugs. The alert was based on a review of adverse event reports collected from March 2013 to June 2014 – before Jardiance was approved. Id. at *3-4.

Products liability claims in Tennessee are governed by the Tennessee Products Liability Act. Under the TPLA, drug manufacturers have a duty to minimize the risk or dangers from their products and they can discharge that duty by providing adequate warnings and instructions. Id. at *7. Plaintiff in Mitchell alleged defendant failed to satisfy that duty because it did not warn about DKA at the time the drug was approved and did not amend the warning via the FDA’s Changes Being Effected (“CBE”) process at any time before plaintiff was injured. Id. at *4.

We see CBE and we immediately start looking for a preemption discussion. Sure enough, there is one. As discussed here many times before, the CBE process allows a manufacturer to add or strengthen a warning based on “newly acquired information” without first obtaining FDA approval. Id. at *9-10. Where a CBE label change is an option for a manufacturer, the Supreme Court has held that failure to warn claims are not preempted. See Wyeth v. Levine, 555 U.S. 555 (2009).

But what about when a CBE is not an option? In Mitchell, the court broke the plaintiff’s failure to warn claim into two pieces – a challenge to the original labeling and a challenge to warning as it was at the time plaintiff used the drug. The court found the former preempted because defendant could not have changed the original FDA approved labeling. The data plaintiff relied on to support her allegation on this claim was pre-launch data. In other words, data that was known to the FDA at the time they approved the drug’s warnings – not newly acquired. “[T]he FDA is the exclusive judge of safety and efficacy based on information available at the commencement of marketing.” Id. at *11 (citing  In re Celexa & Lexapro Mktg. & Sales Practices Litig., 779 F.3d 34, 41 (1st Cir. 2015).

Similarly, plaintiff cannot base her failure to warn claim challenging defendant’s failure to amend the warning after the drug was introduced on the market on information that existed pre-FDA approval. Id. at *13. So plaintiff cannot rely on the adverse events collected before June 2014. Plaintiff’s allegations must be based on information that was not known by the FDA at the time of approval. In her complaint, plaintiff alleged that additional DKA adverse events were reported in 2015. Defendant, citing federal regulations, argued that while later in time, the additional reports did not provide any “new” information that would support a CBE. The court determined that was an issue better suited to a motion for summary judgment and that plaintiff had done enough to withstand a motion to dismiss. Id. at *15. Not a win yet, but the door is certainly still open.

The court made a few other rulings as well. Based on the learned intermediary doctrine, plaintiff cannot bring a failure to warn claim premised on failing to warn plaintiff directly. She is limited to a claim for failure to warn her prescriber. Id. at *17-18. And plaintiff must plead warning inadequacies with specificity. The court determined her allegations as to DKA were sufficient. But, plaintiff failed to state a claim to the extent she was looking to recover for “other related health complications.” Id. at *22. Plaintiff’s complaint neither specified the alleged complications nor how the drug’s warnings were inadequate as to those complications. So, as to unspecified complications, the failure to warn claim was dismissed.

In the end, plaintiff is left with a narrow failure to warn claim and the hurdle of proving proximate cause.

We can be inundated with news.  Old news.  New news.  Fake news.  Breaking news.  News that makes you want to break something.  News that makes you want to go back to bed.  In trying to be discerning consumers of the news, it is useful to do not just a reality check but a date check.  Stories on a social media stream come with a presumption of newness, but the date of the release of the story—once you find it—may make you stop reading because it is not news any more.  You may even have read the old news when it was new and just got suckered back by the misimpression of novelty.  A story about a new species of dinosaur, or even beetle, being discovered?  We are clicking.  Einstein’s prediction of gravitational waves verified?  Click—wait, we saw that way back in early 2016, and a Nobel Prize was awarded for that last month.

Generic drug preemption may not be as clickworthy as a “new” ankylosaur, but these decisions do still catch our attention.  After Mensing, Bartlett and scores of published decisions preempting the vast majority of conceivable claims—or holding that state law does not recognize the claim the plaintiff would need to sidestep preemption—you might think that plaintiffs would stop pursuing these claims.  Well, the nonsense that is innovator liability has not provided a viable alternative—although the plaintiffs keep trying (like here and here)—and courts have not yet resorted to Rule 11 for pursuing obviously preempted claims, so the plaintiffs keep trying.  When Kious v. Teva Pharmaceuticals USA, Inc., No. 16-990-R, 2016 WL 9559038 (W.D. Okla. Dec. 8, 2016), popped up in our searches, we thought it might be new and newsworthy.  It really was old news made to seem new because it had taken eleven months to get on Westlaw.  The generic manufacturer defendant secured dismissal of the claims against it on preemption, but was there anything new, different or interesting about it?  We think it is pretty much old hat, but that may be the point.

Kious involves a plaintiff who claims to have developed Stevens-Johnson Syndrome as the result of the use of a generic antibiotic, the label for which apparently matched that of the reference drug.  The plaintiff sued the generic manufacturer, asserting standard state law claims, and a motion to dismiss the amended complaint followed.  (He also sued the branded manufacturer, but that is not discussed in the opinion.)  The court walked through each asserted claim, starting with design defect.  Preemption of such claims is not really a question post-Bartlett, but the Tenth Circuit’s decision in Schrock, discussed here, left no doubt that strict liability and negligence design claims fail.  Id. at *2.  Next up was the claim for manufacturing defect, which was really just a re-packaged claim for design defect.  Plaintiff claimed “that every dose of azithromycin was defective because of its design and/or lack of adequate warnings,” so he did not plead a manufacturing defect claim under Oklahoma law (and the design claim under a different label was still preempted). Id.

Next up were the warnings claims.  Plaintiff did not allege a failure to update the generic label to mirror the reference drug’s label, so Mensing’s application should have been straightforward.  Not so, claimed the plaintiff, because Mensing involved prescriptions written before the Food and Drug Administration Amendments Act of 2007, which established a procedure under which FDA could ask for a new label from a generic manufacturer if the reference drug was no marketed and there is new safety information.  Even this argument, however, was not new, as courts like the Seventh Circuit had already rejected it.  The Wagner decision (a lofty fifth place on last’s year’s best list) made clear that the FDAAA did not remove the prohibition against a generic drug manufacturer changing its label unilaterally.  2016 WL 9559038, *4. Kious went a step further—and we think this was actually novel—and noted that the FDA’s proposed rule from 2013 to allow generic manufacturers to change their labels unilaterally in some situations supports preemption.  “The proposed rule would be unnecessary if, as Plaintiff urges, the 2007 Amendments permitted unilateral labeling changes by generic manufacturer.” Id. No news is good news, at least here, so warnings claims are still preempted.

The remaining claims were also dismissed.  Express warranty claims are really preempted warnings claims and implied warranty claims were really preempted design claims or preempted warnings claims, depending on how construed.  Again, the Schrock decision, also under Oklahoma law, determined the result. Id. at *5.  For the claims of fraud, negligent misrepresentation, and negligent concealment, the court looked to the Eleventh Circuit’s decision in Guarino for clear authority that these were simply another version of preempted warnings claims. Id. at **5-6.  That was it for every claim plaintiff offered and, plaintiff did not get to amend again.  Judgment for the defendant after only two strikes.  Could it be that sanctions for asserting frivolous claims are next in such suits?  That would be news, no matter when it happens.

Interestingly, it’s a case that is almost a year old that has us thinking about litigation tourism post Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017).   We know that plaintiffs’ forum shopping gamesmanship isn’t over. It’s just gotten a lot more difficult now that the Supreme Court has said non-resident plaintiffs can’t go suing non-resident defendants anywhere they want. The most straight forward way for plaintiffs to stay out of federal court, assuming that is their goal, is to sue in defendant’s home state. Per the forum defendant rule, even where diversity exists, a defendant cannot remove a case to federal court if one of defendants (properly joined and served) is a citizen of the state in which the case was filed. See 28 U.S.C. § 1441(b). Stuck in state court, which isn’t always a bad thing, defendants then need to carefully consider forum non conveniens and choice of law issues.

Those were both key issues defendant decided to move on in Yocum v. Biogen, Inc., 2016 WL 10517110 (Mass. Super. Dec. 14, 2016). The case only recently popped up in our searches but with the likelihood of seeing more litigation filed in defendant’s backyards, we thought it worth a quick mention. Plaintiff brought a wrongful death suit in Massachusetts alleging that his wife died as a result of side effects from defendant’s drug used to treat her multiple sclerosis. Id. at *1. Plaintiff resides in and decedent received treatment and died in Wisconsin. Defendant’s principal place of business is in Massachusetts. Id. Just because defendant couldn’t remove the case to federal court, it still had some decisions to make. Such as, would it prefer the case to be litigated in Wisconsin. And, if it couldn’t move the case west, should Wisconsin law still apply. Yes and yes were the answers for this defendant.

First up was a motion to dismiss on the grounds of forum non conveniens.   Defendant’s argument was that not only was Wisconsin an available alternative forum, but that both public and private interests favored litigating there as opposed to Massachusetts. Generally speaking, all things being equal, courts don’t disrupt a plaintiff’s choice of forum. So, where case-specific witnesses like treaters and prescribers are in plaintiff’s home state and company witnesses are in defendant’s home state – most courts see that as a wash. See id. at *3. One set of witnesses or another are either traveling or being put on video. That’s not to say that this is always equal. For instance, if significant depositions of company witnesses have already occurred and won’t need to be repeated, maybe that helps tip things toward the plaintiff’s home state. Or, if the relevant company witnesses have changed jobs, retired, or otherwise moved, the defendant home state connection becomes more attenuated. Likewise, depending on the issues, a large company’s principal place of business might not be where the key company witnesses are located. These are likely the types of things a defendant is going to have to address to move the scales on the private interests.

Turning from the private interests to the public interests, defendant raised two arguments – the court would need to apply Wisconsin law and Wisconsin has a significant interest in regulating tortious conduct alleged to have occurred within the state. Taking them in reverse, the court found that Massachusetts has an equally significant interest in regulating the conduct of a resident business. Id. Another push. Left then with only choice of law, that alone is not enough to warrant a forum non dismissal. Defendant’s motion was denied.

That brings us to choice of law. If defendant can’t get to Wisconsin, it wanted to bring Wisconsin to it. Here the court agreed with defendant. We don’t usually take a definitive position on choice of law issues because frankly, our choice is likely to change case to case. So, we’ll just say that defendant did a good job of explaining why Wisconsin has the more meaningful contacts with the issues and the parties and that it is not an unusual conclusion for a court to decide to apply the law of the place where the injury occurred. Id. at *4-6.

Then we get to the substantive issues. Applying Wisconsin law, the court dismissed plaintiff’s breach of warranty and punitive damages claims. Wisconsin does not recognize breach of warranty for products liability suits. Id. at *6. Nor does Wisconsin recognize claims for punitive damages in wrongful death actions. Id. Both categories of claims, however, were dismissed without prejudice. Plaintiff was given an opportunity to try to re-plead the breach of warranty allegations as cognizable Wisconsin claims. And, since Wisconsin does recognize punitive damages for survival actions, plaintiff was getting another shot at that one too.

Finally, defendant also sought dismissal of the failure to warn claims as preempted. Defendant argued that the risks of the drug were considered by the FDA at the time of approval and that there was no newly acquired information that would have allowed defendant to change its label under the CBE regulations. Id. at *7. Therefore, it was impossible for defendant to comply with both federal and state requirements. But, this case is still at the pleadings stage and the court found that plaintiff had alleged enough to survive preemption. Specifically, plaintiff alleged that there were factual developments post-approval regarding the risks that would not have been considered at the time the FDA reviewed the drug and its labeling. Id. Further, the court found that defendant had not presented “clear evidence” that the FDA would not have approved a labeling change. Id. at *8.

It is worth noting, however, that the court did say that if plaintiff was pursuing a fraud-on-the-FDA type claim (failure to disclose risks to the FDA), that claim was preempted. Id. at *8n.12. Given that the court’s preemption decision was based on a very sparse record, we wouldn’t be surprised to see a round 2 on this issue after some discovery.

If defendants are going to see more home state litigation, even if forum non conveniens is a bit of an uphill battle – establishing choice of law early on may have several benefits. Dismissing claims is certainly one of them, but knowing what law is going to apply on issues such as learned intermediary and causation before discovery gets underway can be invaluable.

 

This post is from the non-Reed Smith side of the blog.

Way back at the start of this year, we posted about a great preemption win on express warranty. Well, that case has worked its way through the appellate process and the Fifth Circuit unfortunately has reversed the decision. But, we aren’t going to rage against the decision as you might expect us to. We aren’t going to laud it either. Rather, we are taking the decision for what it is – the narrowest of preemption escapes based on the unusually detailed nature of what the manufacturer actually said in the alleged warranty. Good luck to plaintiffs trying to use this decision elsewhere. For 99.9% of express warranty cases, this case’s rationale actually is a positive result.

The facts of the case are straightforward. Plaintiff alleged that a neurostimulator implanted in his spine stopped working after one and a half years, had to be explanted, and that he suffered complications from the revision surgery. Wildman v. Medtronic, Inc., 2017 U.S. App. LEXIS 21655 at *2-3 (5th Cir. Oct. 31, 2017). Plaintiff’s only claim was that the defendant breached its express warranty guaranteeing the device for 9 years. The alleged warranty language is important. The defendant’s website said that in addition to battery life, “many other factors and components are involved in determining the overall longevity of an implanted medical device.” And that based on extensive testing of many components, not just the battery, defendant had “confidence that [its] device is reliable for 9 years.” Id. at *4. Plaintiff alleged these statements were not reviewed or approved by the FDA. The device’s reference manual did undergo FDA review and approval as part of the PMA process. The manual contains an approved FDA statement that the device’s “battery life” was 9 years. Id. at *5. It is the distinction between “battery life” and “device life” that is at the crux of the court’s decision.

Why is that so important? Because that Fifth Circuit stated definitively that “when a claim challenges a representation the FDA blessed in the approval process, it is preempted.” Id. at *8. Could not be any clearer. Hence the reason this decision is probably more beneficial to defendants generally than to plaintiffs. Because the manufacturer’s website drew a distinction between the battery and the rest of the components, the court found the language was guaranteeing the reliability of the latter but that the FDA had only evaluated the former. Id. at *9. A verdict that the defendant’s representation was misleading or untruthful would therefore not run counter to any safety finding by the FDA. Instead, it would parallel federal regulations prohibiting false or misleading statements about medical devices.  Id. at *10-12.

The Fifth Circuit goes on to point out that where an express warranty claim survives preemption, it also still has to meet the TwIqbal pleadings standards. Therefore, an express warranty claim based on “vague allegations about representations . . . made to doctors or consumers” isn’t enough. Id. at *13. Another defense-favorable holding emphasizing that Wildman is an aberration.

Even though the case is being remanded, plaintiff hasn’t proven anything yet. Far from it. As the court points out, to prove his express warranty claim under Texas law is going to require both reliance and notice. Id. at *8n.3. It’s also going to require proof that something other than the battery caused the device to fail. Id. at *13-14. Plaintiff already amended his complaint to change from his more specific allegation that the device failed due to the battery to a more general allegation that the “neurostimulator did not conform to a nine-year device life.” Id. at *5. But does that general allegation meet the mark on the TwIqbal yardstick? The only claim that escapes preemption is a narrow one – did defendant breach a warranty about the longevity of some component other than the battery. On remand, the first issue for the district court is to determine whether plaintiff’s complaint sufficiently alleges facts to support such a claim. Again we say good luck on that.

The case may be, for the moment, revitalized, but the opinion bringing it back to life had enough juice worth the squeeze for defendants.

For over fifty years, the BBC has been chronicling the exploits of that ultimate learned intermediary, Dr. Who.  Over the decades, successive Doctors have crossed swords (or sonic screwdrivers) with a wide variety of enemies, from the Master, through Daleks, Cybermen, Zygons, and Mara.  But for us, there is no more terrifying foe than the Vashta Nerada.  In the episodes “Silence in the Library” and “Forest of the Dead,” these microscopic piranha of the air lurk in the shadows until swarming around their next victim, whom they reduce to skeletal leftovers in seconds.  Shortly before the end, those selected for consumption by the Vashta Nerada take on an unusual characteristic – they have two shadows.

Which is similar to how we see Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (“Lohr”).  We think that decision is close to the end – in Gallifreyan terms, it has two shadows.

Bexis still remembers when Lohr came down, like it was yesterday.  Just a few months before, in the Bone Screw litigation (involving Class II devices), the defendants had won an order holding that probably 85% of the plaintiffs’ allegations were preempted.  See In re Orthopedic Bone Screw Products Liability Litigation, 1996 WL 221784 (E.D. Pa. April 8, 1996) (interestingly, this decision doesn’t have a red flag, although it should).  Bexis had also written an amicus curiae brief in Lohr that articulated the defense position on negligence per se issues (available at 1996 WL 109632).  Lohr said good-bye to all that.  The section of Lohr concerning what has become the so-called “parallel claims” exception to preemption was 9-0 (in other words, Bexis got skunked).  The rest of Lohr, concerning preemption of design and warning claims, was ostensibly 5-4, although Justice Breyer’s concurrence (necessary to make a majority) wasn’t exactly on all fours as to the reasoning.

It’s been over 20 years since Lohr, and that decision hasn’t aged well.  We discuss why in this post.

The key to Lohr’s reasoning – particularly in light of the subsequent decision in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) – is its distinguishing of the FDA pre-market approval (“PMA”) process from the “expedited” §510(k) clearance that the device before the Court had undergone in 1982.  518 U.S. at 480.  Pre-market approval was “rigorous” safety review:

Before a new Class III device may be introduced to the market, the manufacturer must provide the FDA with a “reasonable assurance” that the device is both safe and effective.  See 21 U.S.C. § 360e(d)(2).  Despite its relatively innocuous phrasing, the process of establishing this “reasonable assurance,” which is known as the “premarket approval,” or “PMA” process, is a rigorous one.  Manufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews.

Id. at 477 (emphasis added).

By contrast, “substantial equivalence” clearance for marketing and labeling did not (according to the lead Lohr opinion) impose the same standard as PMA.  Section 510(k) – codified as 21 U.S.C. §360(k) and following the FDA procedure detailed in §360c(i) – was viewed as a “grandfathering provision which allows pre-1976 devices to remain on the market without FDA approval.”  Lohr, 518 U.S. at 478.  It “permits devices that are ‘substantially equivalent’ to pre-existing devices to avoid the PMA process.”  Id.  A majority in Lohr held that “[t]he § 510(k) notification process is by no means comparable to the PMA process.”  Id. at 475-79.

In Lohr, the Court held that preemption under 21 U.S.C. §360k “does not occur in a contextual vacuum.  Rather, that interpretation is informed by two presumptions about the nature of pre-emption.”  Id. at 485.  The “first” and most important of these presumptions in Lohr was:

In all pre-emption cases, and particularly in those in which Congress has legislated in a field which the States have traditionally occupied, . . . we use[] a “presumption against the pre-emption of state police power regulations” to support a narrow interpretation of such an express command.

Id. (citations and quotation marks omitted) (emphasis added).  The second presumption was even more extra-textual – that the Court looks “not only in the [statutory] text,” but also to “the structure and purpose of the statute as a whole” in evaluating congressional “purpose.”  Id. at 485-86.

By then, it was clear where Lohr was going.  The majority construed the language of §360k(a) “narrowly,” and when that was not enough, it looked to its gestalt conception of the overall purpose of the FDCA, again in preference to the language Congress actually drafted in §360k(a).

Looking at the entire statute, the Lohr lead opinion found no private FDCA cause of action.  518 U.S. at 487.  It declared the argument “implausible” that “Congress would have barred most, if not all, relief for persons injured by defective medical devices,” even though that result was what a literal reading of “different from or in addition to” would produce. Id. To avoid that result, it decided:

  • “[R]equirement,” as used in §360k(a) should not be given “its widest reasonable meaning” because of the potentially “broad” “scope of the preclusion that would occur.”  Id. at 488-89.  Instead, the lead Lohr opinion held that preemption “was primarily concerned with the problem of specific, conflicting state statutes and regulations rather than the general duties enforced by common-law actions.”  Id. at 489. This result could be inferred from silence in the legislative history.  Id. at 491.
  • Nothing in the “the statutory scheme or the legislative history” – in other words, still more silence – suggested that §510(k) “was intended to do anything other than maintain the status quo,” which included “common-law tort suits,” so the express preemption language could not be taken “literal[ly].”  Id. at 494-95.
  • A parallel violation claim can “be ‘different from’ the [FDA] rules in a literal sense,” but still escape preemption because it is “narrower” than an FDA requirement, “not broader,” by adding a requirement of negligence.  Id. at 495.
  • “The presence of a damages remedy does not amount to the additional or different ‘requirement’ that is necessary under the statute; rather, it merely provides another reason for manufacturers to comply” with FDA requirements.  Id.
  • An FDA regulation, 21 C.F.R. §808.1(d), “interpret[ed] the scope of § 360k’s pre-emptive effect,” and disclaimed preemption of “general” state-law requirements, requiring instead “specific counterpart regulations.  Id. at 496-97.  Lohr gave that regulation “substantial weight” in its preemption analysis.  Id. at 496.
  • “[P]re-emption [can] occur only where a particular state requirement threatens to interfere with a specific federal interest.  State requirements must be ‘with respect to’ medical devices and ‘different from, or in addition to,’ federal requirements.”  Id. at 500.
  • FDA “regulations provide that state requirements of ‘general applicability’ are not pre-empted except where they have ‘the effect of establishing a substantive requirement for a specific device.’  Moreover, federal requirements must be ‘applicable to the device’ in question, and, according to the regulations, pre-empt state law only if they are ‘specific counterpart regulations’ or ‘specific’ to a “particular device.’”  Id.

As to the particular tort claims brought by the plaintiffs in Lohr, the lead opinion further discounted the scope of the substantial equivalence in §510(k), holding that “[t]he 510(k) process is focused on equivalence, not safety,” and “provide[s] little protection to the public.”  Id. at 493 (citation and quotation marks omitted) (emphasis original).  Lohr took the position that this process “did nothing more than compare one device to another, already marketed device, requiring only compliance with ‘general standards,’ the lowest level of protection.”  Id.

Further, substantial equivalence review “did not ‘require’” the design of the product “to take any particular form for any particular reason.”  Id. at 493.  Nor were any “labeling and manufacturing requirements” of §510(k) “‘applicable to the device’ in question” because they were “entirely generic” and were “applicable to a host of different devices.”  Id. at 498-99 (once again relying on 21 C.F.R. §808.1(d)).  “General” state-law product liability claims “are no more a threat to federal requirements than” “fire prevention requirements” or “zoning codes.”  Id. at 501.

Therefore, “few, if any, common-law duties have been pre-empted by this statute.”  Id. at 502.  Even then, to find preemption would “require a careful comparison between the allegedly pre-empting federal requirement and the allegedly pre-empted state requirement.”  Id. at 500.

From the outset uncertainty reigned as to Lohr.  Four justices dissented from the entire rationale that departed from the text of §360k(a), and from the ensuing result, except as to design and violation claims.  Lohr, 518 U.S. at 509, 513 (dissenting opinion).  Justice Breyer’s concurring opinion, necessary to make a majority as to most parts of the opinion, expressly disagreed “that future incidents of MDA pre-emption of common-law claims will be ‘few’ or ‘rare.’”  Id. at 508.  Justice Breyer based his result largely on the FDA’s regulation restricting the scope of the statute’s preemptive effect.  Id. at 505-06.

What happened “next” had actually happened before Lohr, but had not been relevant to Lohr’s 1982-cleared device.  In response to precisely the sort of lack-of-safety-review criticism of the original §510(k) process, as had been leveled by the lead Lohr opinion, Congress rewrote that part of the FDCA in 1990 in what is called the “Safe Medical Devices Act” (“SMDA”).  Lohr mentioned the SMDA in a footnote that addressed none of its implications.  See 518 U.S. at 480 n.4.  Here’s the SMDA’s statutory gobbledygook:  PL 101-629, November 28, 1990, 104 Stat 4511.  After 1990, the new version of §360c(f) read, in pertinent part:

(f) Initial classification and reclassification of certain devices

(1) Any device intended for human use . . . is classified in class III unless–

(A) the device . . . (ii) is substantially equivalent to another device within such type. . . .

(2)(A)(i) Any person who submits a report under section 360(k) [that’s §510k] for a type of device. . . .

(v) . . . may recommend . . . classification in class II, include in the request an initial draft proposal for applicable special controls . . . that are necessary, in conjunction with general controls, to provide reasonable assurance of safety and effectiveness and a description of how the special controls provide such assurance.  Any such request shall describe the device and provide detailed information and reasons for the recommended classification.

(Emphasis original). Thus, the SMDA extended to §510(k) substantial equivalence the same “reasonable assurance of safety and effectiveness” standard that Lohr described as “rigorous” in connection with premarket approval.  518 U.S. at 477.

In the SMDA, all “Class II” devices – the classification for the vast majority of §510(k) devices − were expressly made subject to this “reasonable assurance” standard.  To meet this standard, the SMDA also authorized the FDA to impose a wide variety of device specific “special controls”:

(B) Class II, special controls–

A device which cannot be classified as a class I device because the general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines . . ., recommendations, and other appropriate actions as the Secretary deems necessary to provide such assurance.  For a device that is purported or represented to be for a use in supporting or sustaining human life, the Secretary shall examine and identify the special controls, if any, that are necessary to provide adequate assurance of safety and effectiveness and describe how such controls provide such assurance.

21 U.S.C. §360c(a)(1)(B) (emphasis added).

The SMDA also revamped the substantial equivalence process itself, expanding 21 U.S.C. §360c(i), defining “substantial equivalence,” so that “safety and equivalence” became an express part of this process.  This statutory section is really long and complex, so here are the most relevant excerpts:

  • Any “different technological characteristics” in a device “demonstrate[ed]” to be “as safe and effective as a legally marketed device,” by “appropriate clinical or scientific data if deemed necessary by the Secretary” “do[] not raise different questions of safety and effectiveness than the predicate device.”  §360c(i)(1)(A)(ii).
  • “[A] submission under section 360(k) of this title . . . shall provide an adequate summary of any information respecting safety and effectiveness.”  §360c(i)(3)(A).

See generally Hall & Mercer, Rethinking Lohr:  Does “SE” Mean Safe and Effective, Substantially Equivalent, or Both?, 13 MINN. J.L. SCI. & TECH. 737, 747-50 (2012) (discussing SMDA).

Thus, at the time Lohr was decided, the SMDA had already rectified most of the lead opinion’s criticism of the earlier §510(k) process – (1) upgrading the regulatory review standard to the “reasonable assurance of safety and equivalence” level that Lohr praised as “rigorous,” (2) imposing on the FDA the duty to evaluate “safety and effectiveness” in its §510(k) evaluations, and (3) providing the Agency with discretionary authority to issue various types of device-specific “special controls.”

The Supreme Court began receding from Lohr in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), albeit under an implied preemption rationale.  Buckman also involved §510(k)-cleared devices, as to which the FDA is “empowered to require additional necessary information” to facilitate the agency’s substantial equivalence determinations.  Id. at 348 (citing 21 C.F.R. §870.87(l)).  In Buckman a unanimous Court limited Lohr on two fronts.  First, the Lohr presumption against preemption was avoided because the “dealings with the FDA,” that were central to the plaintiffs’ fraud and violation claims were “inherently federal in character,” so that “no presumption against pre-emption obtains.”  Id. at 348.  Second, Buckman used implied preemption to prune the Lohr’s parallel violation claim rationale considerably.  Another provision of the FDCA, that Lohr’s gestalt analysis of FDCA purpose had somehow overlooked, established the express intent of Congress to preclude private enforcement of the FDCA by plaintiffs alleging violation claims.  “[W]e have clear evidence that Congress intended that the MDA be enforced exclusively by the Federal Government.  21 U.S.C. § 337(a).”  Id. at 352.

[T]he [Lohr] claims arose from the manufacturer’s alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements.  In the present case, however, the fraud claims exist solely by virtue of the FDCA disclosure requirements.  Thus, although [Lohr] can be read to allow certain state-law causes of actions that parallel federal safety requirements, it does not and cannot stand for the proposition that any violation of the FDCA will support a state-law claim. . . .  “[F]raud-on-the-agency claims . . . would not be relying on traditional state tort law [but] . . . [o]n the contrary, the existence of these federal enactments is a critical element in their case.

Id. at 352-53 (emphasis added).  Thus, violation claims can’t be “solely” based on FDCA infractions, but must “parallel” existing state tort law.  Preemption precludes purported state-law claims that depend on a “federal enactment” as a “critical element” of a private plaintiff’s case.

The Court returned to express preemption in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  Further undercutting Lohr, a 7-2 majority dispensed with any presumption against preemption (only the dissent mentioned it, id. at 334).  Riegel viewed Lohr as “disclaim[ing] a conclusion that general federal requirements could never pre-empt” and holding only “that no pre-emption occurred in the case at hand based on a careful comparison between the state and federal duties at issue.”  Id. at 322.  The majority in Riegel thus converted what Lohr had observed about the “rigor” of FDA premarket review into a preemptive holding.  The FDA “grants premarket approval only if it finds there is a ‘reasonable assurance’ of the device’s ‘safety and effectiveness.’”  Id. at 318.

[P]remarket approval is specific to individual devices.  And it is in no sense an exemption from federal safety review − it is federal safety review.  Thus, the attributes that Lohr found lacking in §510(k) review are present here. . . .  [P]remarket approval is focused on safety, not equivalence.  While devices that enter the market through §510(k) have “never been formally reviewed under the MDA for safety or efficacy,” the FDA may grant premarket approval only after it determines that a device offers a reasonable assurance of safety and effectiveness, §360e(d).  And while the FDA does not “‘require’” that a device allowed to enter the market as a substantial equivalent “take any particular form for any particular reason,” the FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness.

Id. at 323 (Lohr citations omitted) (most emphasis added).

Unrestricted by artificial presumptions, Riegel further rejected Lohr’s crabbed view of “requirements” in §360k(a) – “adher[ing] to the dissent in Lohr, and observing that “[i]n interpreting two other statutes we have likewise held that a provision pre-empting state ‘requirements’ pre-empted common-law duties.”  552 U.S. at 324 (citations omitted).  From then on, a statutory “reference to a State’s ‘requirements’ includes its common-law duties.”  Id.  When plaintiffs raised 21 C.F.R. §808.1(d), to which Lohr’s lead opinion and Justice Breyer’s concurrence had deferred, the Riegel majority gave that regulation the back of their collective hands.  It “neither accept[ed] nor reject[ed] the proposition” that a “regulation can properly be consulted to determine the [FDCA’s] meaning,” id. at 329, but blasted this particular regulation as “adding” only “confusion” to the preemption analysis:

[Plaintiffs’] reading of §808.1(d)(1), however, would allow a claim for tortious mislabeling to escape pre-emption so long as such a claim could also be brought against objects other than medical devices.  All in all, we think that §808.1(d)(1) can add nothing to our analysis but confusion.

Id.  That was a 180° reversal of Lohr.  More would follow.

Moreover, the same negative inference from the lead opinion in Lohr, that Congress wouldn’t “without comment, remove all means of judicial recourse” for medical device plaintiffs, didn’t work go over so well in Riegel:

[A]s we have explained, this is exactly what a pre-emption clause for medical devices does by its terms.  The operation of a law enacted by Congress need not be seconded by a committee report on pain of judicial nullification.

Id. at 326 (rejecting Lohr rationale).  Even though the FDA in Riegel supported preemption, the majority “found it unnecessary to rely upon that agency view because we think [§360k(a)] itself speaks clearly to the point at issue.”  Id.  So much for all the ambiguity that Lohr professed to find in the same language.

Finally, Riegel declined to decide anything concerning parallel violation claims, because that issue was waived.  Id. at 330 (plaintiffs “made no such contention in their briefs before the Second Circuit, nor did they raise this argument in their petition for certiorari”).  However, Riegel included some dictum in the paragraph about waiver – “§360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal requirements,” id. – that has been universally converted by the lower courts (probably to the surprise and chagrin of the Riegel majority) into an endorsement of the concept of “parallel claims,” something that the Riegel Court in fact declined to decide.

Next, in Wyeth v. Levine, 555 U.S. 555 (2009), a prescription drug implied preemption case not dealing with anything analogous to §360k(a), the presumption against preemption was back in full force.  “[I]]n all pre-emption cases, and particularly in those in which Congress has ‘legislated . . . in a field which the States have traditionally occupied,’ . . . we ‘start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.’” Id. at 565 (quoting Lohr, 518 U.S. at 485).  Since Levine dealt with implied preemption and drugs, as opposed to express preemption and medical devices, not much else in Levine is particularly relevant to this post.  For completeness, here is a list of every Lohr citation in the 6-3 majority opinion in Levine:

  • “While agencies have no special authority to pronounce on pre-emption absent delegation by Congress, they do have a unique understanding of the statutes they administer”  Id. at 576-77 (citing Lohr).

That’s it − only this one other Lohr citation in Levine.  Moreover,  the agency deference decision in Levine was not at all supportive of the deference that Lohr accorded the Agency’s regulation:

[T]he Court has performed its own conflict determination, relying on the substance of state and federal law and not on agency proclamations of pre-emption.

Id. at 576.  Otherwise, the majority in Levine evidently did not think that Lohr was particularly relevant to any substantive preemption points, and to that extent we agree.

PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (“Mensing”), like Levine, involved implied preemption and prescription drugs, finding preemption extended to bar common-law warning claims concerning generic drugs.  For present purposes, that aspect of Mensing doesn’t matter.  What does matter is that a majority of the Court refused outright to place reliance on an FDA regulation to interpret the preemptive scope of the FDCA.  Mensing completely rejected this pillar of the Lohr decision:

Although we defer to the [FDA’s] interpretation of its regulations, we do not defer to an agency’s ultimate conclusion about whether state law should be pre-empted.

Id. at 613 n.3 (citing Levine, 555 U.S. at 576).

Mensing also rejected Lohr’s refusal to take Congress at its preemptive word.  If the manner in which Congress wrote the statute included broad preemption, the Court would not usurp the power of Congress to “fix” what Congress did:

[I]t is not this Court’s task to decide whether the statutory scheme established by Congress is unusual or even bizarre. . . .  We will not distort the Supremacy Clause in order to create similar pre-emption across a dissimilar statutory scheme.  As always, Congress and the FDA retain the authority to change the law and regulations if they so desire.

Id. at 625-26 (citation and quotation marks omitted).

In 2015, a then-obscure appellate judge named Gorsuch decided the PMA medical device preemption case Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015).  Judge (now Justice) Gorsuch thus had a close encounter with the mess that Lohr’s refusal to interpret §360k(a)’s preemptive language according to its terms had created over the course of (then) almost two decades.  We’ve already discussed these observations at length, so we’ll only hit the highlights here – in another set of bullet points:

  • Congress “[e]xercis[ed] its authority under the Supremacy Clause” in enacting 21 U.S.C. §360k(a).  Caplinger, 784 F.3d at 1336.
  • “Section 360k(a) preempts ‘any requirement’ imposed by states on manufacturers that differs from or adds to those found in the FDCA.  Given this expansive language one might be forgiven for thinking all private state law tort suits are foreclosed.”  Id. at 1337.
  • Since Lohr, judges have “struggle[d]” to make sense of medical device preemption, since The Supreme Court’s “divergent views” about §360k(a) have “yielded considerable ‘uncertainty’ among the lower courts.”  Id. at 1337-38.
  • The “damages remedy” that Lohr found not “different from” FDCA requirements is “nowhere provided for in federal law.”  Id. at 1338.
  • Lohr’s parallel claims analysis “doesn’t appear in the statute, so its meaning was left entirely to judicial exposition.”  Id.
  • “Now, you might ask, why isn’t a narrower state law requirement at least ‘different from’ a broader federal requirement − and thus preempted by §360k(a)’s express terms?  The Lohr majority acknowledged that a state duty imposing a ‘narrower requirement’ is indeed ‘different from’ the federal rules in a literal sense.’  And when it comes to interpreting the text of a statute, that’s often the sense that matters most.”  Id.
  • “[A]gain read literally, it would seem ‘any’ federal requirement imposed by the FDCA is capable of preempting any different or additional state requirement.  But again the Lohr majority held otherwise,” and instead required a “regulation ‘specific’ to a ‘particular device.’”  Id. at 1339.
  • Despite the “clear” language of 21 U.S.C. §337(a), “lower courts must now accept . . . the notion that §360k(a) permits private tort suits that do no more than parallel the MDA.”  Id.
  • All three subsequent Supreme Court decisions – Buckman, Riegel, and Levine – “cut back on the scope of [Lohr’s] initial decision” and “retreated from” Lohr’s rationale.  Id. at 1339-40.
  • “It’s no small mystery why the same word – ‘any’ − should bear such different meanings in two such similar clauses that lie cheek by jowl in the same statutory subsection.”  Id. at 1340.
  • “[W]e may find the state law claim preempted only if there exists a device-specific federal requirement, though this test admittedly finds no analogue when it comes to the state requirement clause interpreted in Riegel.”  Id.
  • Section 360k(a) “specifies its preemptive reach plainly and broadly: any state requirement that adds to federal requirements and that relates to the safety or effectiveness of the device is preempted. No other qualification exists.”  Id. at 1345.
  • “[I]t is not for this court to revise [§360k(a)] by beating a new path around preemption nowhere authorized in the text of the statute.”  Id. at 1347.
  • Not just pre-market approval, but “something like it,” should have preemptive effect.  Id. at 1339.

Thus, with respect to Lohr, Judge Gorsuch couldn’t “help but wonder if perhaps some of those rules warrant revisiting and reconciliation.”  Caplinger, 784 F.3d at 1340.  We think that’s a great idea – the sooner the better.

Then, in Lohr’s twentieth anniversary year, the decision’s most important doctrinal underpinning was flat out overruled.  As we’ve also discussed before, the Supreme Court abolished the presumption against preemption in express preemption cases where Congress has included language explicit preemption language such as §360k(a):

The plain text of the [preemption clause] begins and ends our analysis. . . .  And because the statute contains an express pre-emption clause, we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.

Puerto Rico v. Franklin California Tax-Free Trust, ___ U.S. ___, 136 S. Ct. 1938, 1946 (2016) (“Franklin”).  Accord Watson v. Air Methods Corp., 870 F.3d 812, 817 (8th Cir. 2017) (following Franklin and rejecting presumption against preemption in express preemption case); EagleMed LLC v. Cox, 868 F.3d 893, 903, (10th Cir. 2017) (same); Atay v. Cty. of Maui, 842 F.3d 688, 699 (9th Cir. 2016) (same); Conklin v. Medtronic, Inc., ___ P.3d ___, 2017 WL 4682107, at *2 (Ariz. App. Oct. 19, 2017) (under Franklin courts may not invoke a presumption against preemption in PMA preemption cases); Olmstead v. Bayer Corp., 2017 WL 3498696, at *3 n.2 (N.D.N.Y. Aug. 15, 2017) (plaintiff’s assertion of presumption against preemption in PMA preemption case held “frivolous” after Franklin).

That turned out the lights on Lohr.

Bringing the chronology to a close, earlier this year, the FDA itself reiterated that “safety and effectiveness” was baked into the §510(k) “substantial equivalence” review process by the SMDA.  See FDA, “Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products” (Jan. 17, 2017).  Thus, the FDA recognizes that “principles of safety and effectiveness underlie the substantial equivalence determination in every 510(k) review.”  FDA memo at 44 (footnote omitted).  Again, we discussed this development in detail when it happened, so we’ll simply summarize the FDA’s views here:

  • While “approval application (PMA) . . . and 510(k)) differ in various ways, they all . . . enable[] FDA to ensure that devices on the market are ones that have been determined by FDA to have a reasonable assurance of safety and effectiveness.”  Id. at 40.
  • “Congress . . . required FDA to evaluate whether a new device is as safe and effective as a predicate device.”  Id. at 44 n.137 (specifically discussing SMDA).
  • Under §510(k), “[c]lassification determinations must be based on an evaluation of the safety and effectiveness of the device.”  Id. at 41.
  • “Class II devices are devices for which general controls, by themselves, are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls necessary to provide such assurance.”  Id. at 41 n.122.
  • “During the 510(k) review, FDA considers the device’s safety and effectiveness in its substantial equivalence determination.”  Id. at 43.
  • [T]he 510(k) . . . review process reflects a determination of the level of control necessary to provide a ‘reasonable assurance of safety and effectiveness.’”  Id. at 44-45.

While the FDA’s 2017 public position on the nature of §510(k) clearance should be quite sufficient, since the SMDA was enacted in 1990 the FDA has issued a variety of other documents that contain similar statements.  For instance, in the currently posted discussion of “Regulatory Controls” on the FDA’s website, the description of “special controls” for “class II devices” makes clear that:  (1) “[s]pecial controls are regulatory requirements,” and (2) “Special controls are usually device-specific.”  The FDA’s “design control” regulation, 21 C.F.R. §820.30(a)(1), provides that, “[e]ach manufacturer of any . . . class II device . . . shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.”  This regulation imposes additional requirements on design “development,” “input,” “output,” “review,” “verification,” “validation,” “transfer,” “changes,” and “history.”  Id. §§820.30(d-j).

Just the other day the FDA issued a guidance document on when a change to a §510(k) device requires submission of a new notification to the Agency.  That guidance reiterates that “whether submission of a new 510(k) is required depends on whether the change could significantly affect the safety or effectiveness of the device.”  FDA, “Deciding When to Submit a 510(k) for a Change to an Existing Device,” Guidance for Industry, at 8 (Oct. 25, 2017).  Likewise, an FDA working report from 2010 recognized:

[T]he 510(k) program has changed significantly since its inception.  The MDA established the premarket notification process as a simple check to assure proper device classification.  Through various statutory and regulatory modifications over time, it has become a multifaceted premarket review process that is expected to assure that cleared devices, subject to general and applicable special controls, provide reasonable assurance of safety and effectiveness, and to facilitate innovation in the medical device industry.

FDA, “CDRH Preliminary Internal Evaluations – Volume I, 510(k) Working Group Preliminary Report & Recommendations, at 34 (Aug. 2010) (§4.4 “The Current 510(k) Program”) (available online here) (emphasis added).  In many instances, device specific FDA guidance, regulatory manuals, and other similar documents will provide additional regulatory proof of actual preemptive requirements imposed by the Agency upon particular devices or device types.

At this point, Lohr plainly has two shadows from a jurisprudential perspective.  Essentially all of the propositions upon which its anti-preemptive rationale was based have been changed by Congress, or overruled by subsequent Supreme Court decisions.

First, The SMDA applied the same pre-market approval “reasonable assurance of safety and effectiveness” standard to §510(k) and gave the FDA the tools – a broad selection of “special controls” −  to create the kind of “device specific” controls that preemption under Lohr required.  The FDA has recognized on many occasions that safety and effectiveness is at the core of modern “substantial equivalence” determinations.

Second, Riegel held that the identical “rigorous” “reasonable assurance of safety and effectiveness” standard of FDA safety review is broadly preemptive.

Third, Franklin outright abolished the central guiding principle in Lohr − the presumption against preemption in express preemption cases is no more.

Fourth, Lohr’s gestalt approach allowing diffuse, general Congressional purpose to override preemptive statutory provisions has been rejected in Riegel and Mensing.  If the statute’s language requires preemption, then that is what Congress “intended” – unless and until Congress changes it.

Fifth, Lohr’s reliance on an agency regulation to constrict the preemptive scope of that agency’s organic statute was questioned in Riegel and Levine before being rejected outright in Mensing.

Sixth, to the extent that Lohr distinguished state statutory/regulatory enactments and state common law in interpreting “requirements” as that term was used in §360k(a), Riegel definitively rejected that distinction.

SeventhLohr’s “parallel” claim analysis was restricted in Buckman, and avoided as waived in Riegel.  Justice Gorsuch hates all the extra-textual hair splitting that has sprung up around the Riegel dictum, and as a result appears to be the kind of advocate we would want on Court for reconsidering and overruling Lohr.

So what do we need?

We need good cases – not kamikaze motions in MDLs with institutional (at least) bias against preemption.  We need cases where the FDA has, in fact, imposed device-specific special controls that specify design, warnings, clinical testing, and other relevant attributes of §510(k) medical devices.  Only in such carefully selected cases, and after the compilation of a full regulatory record, will the “careful comparison” that even Lohr recognized could lead to preemption be able carry the day for the defense.  That may change later on, once preemption becomes better established in post-SMDA §510(k) cases, but for now we’re not doing ourselves any favors making preemption motions on threadbare records or before judges predisposed to reject preemption arguments.

Lohr should be dead.  Long live preemption.

A talisman is something thought to protect whoever has it from evil or harm.  In the old days a talisman might be something like garlic to ward off vampires or the Seal of Solomon to keep away various evil spirits.  Nowadays, there aren’t so many – although it seems there are some people out there who appear to view Robert Mueller as something of a talisman.

How about preemption?

We noticed something recently in the course of making sure that our preemption scorecards for PMA device and generic drug preemption are current.

We don’t see many preemption cases that need to be included in either scorecard coming out of multi-district litigation.  For example, in the PMA preemption scorecard, there are exactly five cases with “In re” in their title.  The last one was In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200 (8th Cir. 2010), which involved a pre-Riegel MDL essentially getting wiped out by a single preemption motion.  Since Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), as far as we can tell from following the case law, not a single new MDL has been created involving a pre-market approved device to which extensive Riegel preemption would apply.  Sure, there has been fairly extensive post-Riegel litigation involving some PMA devices – Infuse and Essure come to mind – but no MDL where bad cases can go to hide until a single MDL judge produces enough bizarrely pro-plaintiff rulings and/or consolidated bellwether show trials to bludgeon the defendant into settling.

The same appears to be true in the generic drug area, which also enjoys broad preemption (if not for as long a time as PMA devices).  We find more “In re” captioned cases in our generic preemption scorecard, but for the most part they, as well, look like holdover MDLs involving drugs that were subject to litigation before the preemption hammer came down in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).  We see some Accutane, Darvocet, Yasmin/Yaz, and Fosamax cases, all of which appear to have been in litigation – Sprint Fidelis style – since before Mensing was decided.  We also see various “In re Reglan” citations, but they are from state court.  In federal court, generic Reglan (metoclopramide) cases seem to have been brought on the same individual, if rather common, basis as Infuse or Essure in the device area.  No federal MDL.

The only possible exception to this state of affairs is In re Testosterone Replacement Therapy Products Liability Litigation, 142 F. Supp.3d 747 (N.D. Ill. 2015), which was created after Mensing.  But we don’t really see TRT as an exception, since reading the decision suggests that the litigation really targets branded manufacturers.  The generic plaintiffs who were dismissed were more or less odds and sods generated by the usual excessive solicitation followed by the even more usual inadequate vetting of actions by the other side in mass tort situations.  In any event, the generic Testosterone plaintiffs were wiped out by preemption and that was that.

So, in addition to (or perhaps because of) its other virtues, a strong preemption defense appears to be a talisman that wards off the evil of MDLs/mass torts.  Most defendants have had their fill of MDLS, and most plaintiffs don’t seem to be seeking MDLs in cases involving such products – and with good reason.  As in the aforementioned Sprint Fidelis and Testosterone decisions, a single preemption ruling wiped out all similarly situated plaintiffs in the entire MDL.  Plaintiffs do not want that efficiency like that.  If every Infuse, Essure, or Reglan case were in the same court, then one preemption ruling by a judge inclined to follow Supreme Court precedents means the litigation is over.  Not much chance for a return on all those solicitation costs.  Without MDL coordination, plaintiffs can still try to find that rogue judge here or there willing to find an off-label-promotion or duty-to-update exception to preemption in this or that case.

Look what just fell into our lap. Our blogging about the favorable California Risperdal preemption decision last week shook loose from that same case a subsequent denial of reconsideration of a summary judgment motion in favor of the defendant based on preemption. Risperdal and Invega Prod. Liab. Cases, 2017 WL 4479317 (Cal. Super. July 24, 2017). So what, you say? Old news, you say? Permit us to explain.

As we recounted last week, a California judge granted summary judgment to the defendant based on Wyeth v. Levine “clear evidence” preemption. Six days after that sound and wise ruling, the very unsound and unwise Third Circuit Fosamax decision stumbled into the world. Not surprisingly, the plaintiffs in the Risperdal/Invega litigation cited Fosamax as a basis for the California judge to reconsider the preemption ruling. And while we refer to “California” you should know it was the Los Angeles County Superior Court that ultimately rejected the Third Circuit’s silliness, and, to be even more specific, you should know that the reconsideration-denying judge sits in the Los Angeles Central Civil West Courthouse, not-so-affectionately known by defense hacks as “The Bank.” Plaintiffs often do very well in The Bank. But not this time. So while we’re writing about an Order from almost three months ago, it’s new to us, and it makes for a nice exclamation mark after our recent discussions of the certiorari petition and amicus brief urging SCOTUS to reverse the Third Circuit. Even woefully inattentive readers of this blog will recall how the Third Circuit held that it was up to the jury whether or not a defendant had come up with “clear evidence” (transmogrified into “clear and convincing evidence”) that the FDA would have rejected the warning suggested by the ever-helpful plaintiff lawyers. We hated to call an opinion by our hometown circuit pure hogwash, but that’s what it was. The fact that a judge from The Bank also pronounced the Third Circuit’s ruling to be hogwash is nothing short of remarkable.

The California judge characterized the issue as “who decides” federal preemption. The Third Circuit’s folly in Fosamax was to give the decision to the jury. The California judge held that “Fosamax is not controlling and is wrongly decided.” He then reaffirmed the preemption decision. Unlike the Third Circuit’s decision, the California decision followed authority and was well-reasoned. The California judge looked to two other judges who rejected Fosamax. First, in a hearing earlier this year in the Xarelto litigation, Judge Fallon stated that the clear evidence preemption issue was “a question of law, not for the jury. I’m not even sure they know what preemption is.” In re Xarelto (Rivaroxaban) Prods. Liab. Litig., Dckt. No. 14-MD-2592 (E.D. La. May 1, 2017). We think when Judge Fallon said he wasn’t sure “they” know what preemption is, he was referring to the jury, not the Third Circuit. But we’re not certain. Either way …. Second, in Utts v. Bristol-Myers Squibb, Co.,   2017 U.S. Dist. LEXIS 70317 (S.D.N.Y. May 8, 2017), Judge Cote also declined to follow Fosamax. Judge Cote “cogently noted the importance of resolving these matters of federal supremacy as early as possible in the life of a case (which is only possible when the issue is properly considered a ‘question of law’ for judicial resolution without the jury).” Exactly right. And that is exactly what the Third Circuit missed. Under the Third Circuit’s rule, preemption wouldn’t be decided until a jury returns a verdict, perhaps one containing many zeroes and zero analysis.

The California judge went on to observe that the trial judge in Levine v. Wyeth and the SCOTUS justices in the same case “all simply assumed that the federal preemption question was a matter reserved for the judge and not a jury question.” The same can be said for a squadron of decisions applying Levine. Thus, “Fosamax stands out as an outlier under the circumstances.” In conclusion, the California judge stood by his earlier decision that clear evidence led to preemption, and that “[b]oth the questions of whether proposed label changes are based on ’newly acquired information’ and whether there is ‘clear evidence’ FDA would have not approved the proposed label changes are legal questions for the Court to decide.” The California judge is right about that.

The California judge also “does not see this as a close question but as the only correct ruling that could be made here.” He’s right about that, too.

This post is from the non-Reed Smith side of the blog.

Do as I say, not as I do. A crutch used by parents worldwide to justify their own bad habits while trying to ensure their children don’t repeat them. Technically, it’s being a hypocrite. Sure, parents should strive to set an example through behavior. But frankly, sometimes we’ll settle for hypocritical. Well, a federal court in Massachusetts just said the same applies to the FDA. We’ll explain.

A group of plaintiffs brought a putative class action against a group of pharmaceutical companies alleging that their prescription eye drops were intentionally designed to dispense more liquid than the human eye is capable of absorbing. Gustavesen v. Alcon Laboratories, Inc., — F. Supp.3d –, 2017 WL 4374384, at *1 (D. Mass. Sep. 29, 2017). Plaintiffs allege that therefore, medication is wasted and they are required to more frequently re-fill their prescriptions than is necessary to the financial benefit of the defendants. Id. Plaintiffs sought recovery under various states consumer protection statutes as well as for unjust enrichment and “money had and received.” Id. at *2. Defendants filed a motion to dismiss alleging multiple reasons why plaintiffs’ claims fail as a matter of law. The court opted not to consider anything beyond preemption finding that that precluded all of the alleged claims.

To begin its analysis, the court did a nice walkthrough of what it calls the Supreme Court’s trilogy of impossibility preemption decisions. First, of course, is Wyeth v. Levine, where the Court said failure to warn claims are not preempted because of a manufacturer’s ability to make certain labeling changes without prior approval of the FDA, unless there is clear evidence that the FDA would have rejected the change. Id. at *4. Next up was Pliva v. Mensing. A generic drug is required to have the same labeling as the brand-name version. Therefore, a generic drug manufacturer does not have the same ability to change its label as the brand manufacturer. Id. at *5. And, finally came Mutual Pharmaceutical v. Bartlett. Here the Supreme Court said that plaintiff’s design defect claim was preempted because any attempt by the manufacturer to change the design of the drug would have resulted in a new, unapproved drug that the manufacturer would have been prohibited from marketing. Id. Moreover, the court rejected plaintiff’s claim that defendant could have simply stopped selling the drug – defendant is not required to “cease acting altogether to avoid liability.” Id. Put the three cases together and you have the following framework. If FDA regulations allow a manufacturer to make a change without prior approval, no preemption unless clear evidence change would have been rejected. If “a party cannot satisfy a state law without first obtaining the discretionary approval of a federal agency, the state law is preempted.” Id. at *5.

Against that legal backdrop plaintiff’s argued that they had 2 theories of liability that were not preempted. First, they alleged that defendants could have changed the eye dropper tip to deliver a smaller drop and that this would have been prohibited by the FDA. Id. at *7. There are 3 categories of changes for approved drugs – major, moderate, and minor. Moderate changes are the type of labeling change discussed in Wyeth that do not need pre-approval. Major changes on the other hand must be submitted to the FDA before the drug is distributed. Id. To determine whether something is a major change, the court looked to FDA regulations and FDA guidances interpreting those regulations. In this case, that would include a guidance that for sterile products, like eye drops, any change to the container closure system is a major change. Id. The opinion goes more in depth on these regulations – but the conclusion is what is important. Plaintiff’s proposed design change would be a major change that would require prior FDA approval – therefore, the claim is preempted.

Now we come to the “do as I say” part. In response to defendants’ argument that the design change suggested by plaintiffs would be a major change, plaintiffs cited to three occasions where they claim the FDA allowed a container change without prior approval. As to 2 of the events, the documents relied on by plaintiffs don’t support their position. Id. at *9. As to the third:

At most, this is evidence of the FDA’s failure to follow strictly its own guidance. It does not cast doubt on the plain language of the 2004 Guidance deeming all changes to the size or shape of a sterile product’s container to be major changes requiring preapproval.

Id. Also:

[P]laintiffs cite no law indicating that particular actions by an agency—as opposed to the agency’s official position—are relevant to interpreting a regulation. In fact, the Supreme Court has rejected invitations to apply the standards an agency follows in practice rather than the standards it officially promulgates.

Id. In sum, do as the FDA says, not as it does. The regulations and official guidances control over individualized instances where the FDA chose not to apply them. The court can’t be guided by internal decision-making processes in one-off situations.

Having found that a post-approval change of the eye drop container would have been a major change and therefore claims premised on that preempted, the court examined whether plaintiff could sustain a claim for a “pre-approval” design change. Meaning, could/should defendants have design the dropper tips differently before seeking FDA approval. This question was decided in defendants’ favor by the Sixth Circuit in Yates v. Ortho-McNeil-Janssen Pharm, Inc., 808 F.3d 281 (6th Cir. 2015) (see post here). After examining some other district court authority cited by plaintiffs, the court in this case decided Yates was more consistent with Mensing and Bartlett.

Going back to the trilogy – if a manufacturer can’t satisfy its state law duties without FDA permission, the claim is preempted. Well, it’s not possible for a manufacturer to market a re-designed drug because that drug “would require its own NDA to be marketed in interstate commerce.” Id. at *11. So, arguing that the defendant should have changed the design pre-approval runs straight into the same impossibility preemption as a post-approval design change. Moreover, arguing that the defendant should never have sold the product is virtually the same thing as arguing that it should have stopped selling the product – the theory rejected in Bartlett.

A nice preemption decision, especially the use of Mensing and Bartlett outside the generic realm.