As we discussed in our “breaking news” post, the Supreme Court’s decision in Merck Sharp & Dohme Corp. v. Albrecht, ___ S. Ct. ___, 2019 WL 2166393 (U.S. May 20, 2019) (“Albrecht”), delivered a defense win on the main issue before the Court – that preemption is a question “a question of law, normally for a judge to decide without a jury.”  Id. at *9.  All nine justices agreed that preemption is a question of law.  “We here decide that a judge, not a jury, must decide the pre-emption question.”  Id. at *6.

[T]he question is a legal one for the judge, not a jury.  The question often involves the use of legal skills to determine whether agency disapproval fits facts that are not in dispute.  Moreover, judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination. . . .  And judges are better suited than are juries to understand and to interpret agency decisions in light of the governing statutory and regulatory context.  To understand the question as a legal question for judges makes sense given the fact that judges are normally familiar with principles of administrative law.  Doing so should produce greater uniformity among courts; and greater uniformity is normally a virtue when a question requires a determination concerning the scope and effect of federal agency action.

Id., at *9. (citations and quotation marks omitted).  See also Id. at *12 (“I agree with the Court’s decision on the only question that it actually decides, namely, that whether federal law allowed [defendant] to include in the [drug] label the warning alleged to be required by state law is a question of law to be decided by the courts, not a question of fact.”).

In holding preemption a question of law, the Albrecht Court looked to the resolution of subsidiary factual issues in patent law, relying on Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996).  Markman likewise evaluated the relative competence of judges and juries (after finding originalism unavailing in the patent arena due to lack of available 18th Century case law), and similarly held that complex and technical issues are best decided by trained jurists rather than lay jurors:

[W]hen an issue falls somewhere between a pristine legal standard and a simple historical fact, the fact/law distinction at times has turned on a determination that, as a matter of the sound administration of justice, one judicial actor is better positioned than another to decide the issue in question.”  So it turns out here, for judges, not juries, are the better suited to find the acquired meaning of patent terms.

Id. at 388 (citation and quotation marks omitted).  “[C]redibility” findings – the jury’s “forte” – were typically “subsumed within the necessarily sophisticated analysis of the whole.”  Id. at 389.  “The decisionmaker vested with the task of construing the patent” – that is to say, the judge – “is in the better position to ascertain whether an expert’s proposed definition fully comports with the specification and claims and so will preserve the patent’s internal coherence.”  Id. at 390.  Further, “[u]niformity would, however, be ill served by submitting issues of [patent] construction to juries.”  Id. at 391.  As Albrecht observed, uniformity is also a “virtue” preserved by preemption.  2019 WL 2166393, at *9.  Accord, e.g., Geier v. American Honda Motor Co., 529 U.S. 861, 871 (2000).  Markman provides strong support for defense arguments that factual questions arising in the context of preemption motions are to be decided by judges.

What are the implications of Albrecht’s unanimous ruling?  First, the Court’s rationale does not appear to be limited to any particular form of preemption.  Heck, we see no reason why Albrecht shouldn’t apply to other preemption regimes such as aviation.  But in our sandbox, if factual disputes involving, say, compliance with the FDCA, encountered in the context of implied preemption are to be resolved by judges, the same would logically be true of factual disputes encountered in the context of express preemption.  We note that even the Third Circuit admitted as much.  See In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268, 288 (3d Cir. 2017) (“most preemption cases present purely legal questions − for example, . . . how to interpret the scope of an express preemption provision”), rev’d on other grounds, 2019 WL 2166393 (U.S. May 20, 2019).

For instance, the logic of Albrecht is that, not only should courts decide whether a viable “parallel” claim exists in a PMA medical device case, but they also should resolve the merits of such purported exceptions to preemption.  Instead of juries hearing dueling testimony of plaintiff and defense FDA experts on whether some arcane CGMP was violated in some possibly causal fashion, judges should decide such issues, since the Albrecht Court has unanimously concluded that judges are “better equipped to evaluate” the intricacies of the FDA’s regulatory scheme.  Purported FDA experts like Kessler and Parisian regularly violate the limitation that expert witness should not offer conclusions of law, so confining them to testifying to judges rather than juries is more in keeping with the proper roles of expert witnesses generally.

In this respect, therefore, Albrecht should be of great interest to medical device manufacturers and other defendants litigating express preemption cases.  If preemption, qua preemption, is a question of law, then as in implied preemption cases, judges will no longer be able to hold that “issues of fact” relating to preemption exist as sufficient to deny preemption motions.  Thus, defendants should carefully consider whether a lot of adverse PMA preemption precedent actually applies any longer, given that “a judge, not a jury” must resolve all preemption related factual disputes.

For instance, the Blog has bashed Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), for years, but Bausch’s rationale was that additional “discovery” could allow plaintiffs to establish a factual basis for FDCA violation claims that juries would ultimately decide.  Id. at 560-61.  Now (assuming we’re right about the overall scope of Albrecht) judges are to decide the sort of preemption-avoidance questions raised in Bausch.  So while plaintiffs might still avoid immediate dismissal on the pleadings, targeted discovery and a relatively rapid summary judgment motion should be the rule for parallel claims in the Seventh Circuit.

We caution that nothing in Albrecht means that defendants will win preemption motions all the time – anti-preemption judges will still be anti-preemption − but a lot more preemption cases are going to be decided on the basis of dispositive motions, rather than the can being kicked down the road with a “factual disputes exist” excuse.

Thus, it is quite likely that juries will be hearing fewer regulatory opinions from fewer FDA experts – on both sides.  Judges have to decide preemption issues; they can’t leave them to juries.  Often, but not always, that will be to the defendant’s benefit.  But Albrecht also probably precludes both sides from conducting preemption-related guerrilla warfare during the trial.  Albrecht authorizes courts to refuse, as irrelevant to any question the jury can decide, expert testimony on preemption related issues, such as whether the FDA has imposed this or that “requirement” on a regulated defendant.  On the other hand, both plaintiffs and defendants will have to live with more judicial decisions finding preemption to exist, or not to exist, rather than leaving those issues undecided pending trial.

Second, we think that the point made above about increased judicial decisionmaking in preemption cases is particularly true of “clear evidence” determinations under Albrecht’s new and (we hope) improved definition:

“[C]lear evidence” is evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.

Albrecht, 2019 WL 2166393, at *3.

As we mentioned in our breaking news post, any determination in a state-law-based case of whether the FDA was “fully informed” about anything runs headlong into Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), forbidding plaintiffs in such matters from second-guessing the adequacy of submissions made to the FDA.  Preemption under Buckman applies to:

claims [that] would also cause applicants to fear that their disclosures to the FDA, although deemed appropriate by the Administration, will later be judged insufficient in state court.  Applicants would then have an incentive to submit a deluge of information that the Administration neither wants nor needs, resulting in additional burdens on the FDA[.]

Id. at 351.

Thus, we don’t see Albrecht as providing any basis for allowing plaintiffs to argue to juries that any submission that the FDA found adequate nonetheless provided less than “full information” in some hindsight view.  To the extent that any litigation at all of whether the FDA is “fully informed” is permissible after Albrecht, that would appear to be squarely within the realm of judicial competence discussed in our first point.

Third, what happens when a judge does decide preemption-related factual questions that might arise but are “subsumed within an already tightly circumscribed legal analysis”?  Albrecht, 2019 WL 2166393, at *9.  Here, we look to another patent decision cited in Albrecht, Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831 (2015).  Teva held that, where judges decide subsidiary factual questions in patent (and presumably post-Albrecht preemption) cases, on appeal such factual resolutions cannot be overturned unless “clearly erroneous.”  135 S.Ct. at 836-37 (citing, inter alia, Fed. R. Civ. P. 51(a)(6)).  “[T]his rule and the standard it sets forth must apply when a court of appeals reviews a district court’s resolution of subsidiary factual matters.”  Id. at 836.  So another significant consequence of Albrecht is that, where judicial determination of “contested brute facts,” Albrecht, 2019 WL 2166393, at *9, is necessary to a preemption decision, those findings, on appeal, will likely be subject to relatively deferential “clearly erroneous” appellate review.  After all, under Albrecht, all a judge has to do in deciding preemption is “simply ask himself or herself whether the relevant federal and state laws irreconcilably conflict.”  Id. at *8 (citation and quotation marks omitted).

Thus, both defendants and plaintiffs have even more reason to “be careful what they ask for” when preemption is involved.  If a party forces a judicial decision of a disputed factual issue tied to preemption, it must be prepared to live with the outcome.  Regardless of what the substantive preemption decision is – pro or con – if it involves resolution of factual disputes, the “clearly erroneous” standard (assuming it applies) will make such decisions, formerly treated as legal issues subject to de novo review, harder to overturn on appeal.

Fourth, there is going to be renewed litigation over the preemptive (and perhaps other) impact of FDA decisions that do not, themselves, have force of law.  Justice Thomas’s anti-preemption result was based on a constrained view that an FDA “complete response letter” didn’t have such force, and therefore could not create a preemptive conflict.  Albrecht, 2019 WL 2166393, at *11 (Thomas, J. concurring).  While his view appears idiosyncratic on the current Court, the majority opinion does include the statement that FDA disapproval of warnings may be communicated “by means of notice-and-comment rulemaking setting forth labeling standards, by formally rejecting a warning label that would have been adequate under state law, or with other agency action carrying the force of law.”  Id. at *9 (citations omitted).

Take, for example, the Utah medical device preemption case we discussed recently.  The source of detailed preemptive requirements was an FDA guidance document.  Kelsey v Alcon Laboratories, Inc., 2019 WL 1884225, at *6-7 (Utah Dist. April 22, 2019).  While FDA guidance documents generally do not have force of law, the particular guidance at issue in Kelsey had been incorporated as “special controls” into the device’s formal FDA clearance.  Id. at *10-11.  Thus the preemption ruling in Kelsey should be OK because guidance was incorporated into something else with force of law.  However, any preemption argument that depends in part on an FDA action conveyed via something (like a guidance or a letter) that doesn’t have force of law, will need to show how, as in Kelsey, that action came to have legal effect in each particular case.

The converse should also be true.  Among FDA actions that lack force of law are warning letters, untitled letters, and inspection Forms 483.  We’ve discussed this point numerous times.  See here, here, and here.  Thus, to the extent that Albrecht requires that preemption stem from FDA actions with force of law, we think that it equally precludes preemption from being opposed by evidence of FDA actions, such as warning letters, that themselves lack force of law.

Fifth, and finally, the preemption as a legal issue holding of Albrecht may also have jurisprudential implications.  We’ve also discussed current initiatives (and even proposed our own) to change the Federal Rules of Civil Procedure that apply (or aren’t being applied) to multi-district litigation.  One of the proposals that the Federal Judicial Conference’s committee on Civil Rules is considering is whether to increase the availability of interlocutory appeals in multi-district litigation.  Such appeals would be limited to “important” pre-trial MDL rulings, and of course there is the question of how to define “important.”

But one type of MDL ruling that everyone agrees qualifies as “important” is preemption.  Now that Albrecht has disconnected preemption decisions from factual disputes that require jury resolution, preemption rulings thereby become much more discrete, and thus collateral to, the rest of any given MDL morass.  Thus, Albrecht makes it much easier for the defense side to argue that MDL preemption decisions (including factual determinations arguably subject to “clearly erroneous” appellate review as discussed earlier) are not only important, but procedurally severable, so as to facilitate interlocutory appeal.

We’re sure that Albrecht has other aspects that will also be the subject of litigation, but these are the important ones that occur to us right now.  We will, of course, address any other Albrecht-related issues as they arise.

Perhaps you recall how President Trump campaigned on behalf of “Big Luther” Strange in Alabama. Strange had been appointed by Alabama’s Governor to fill the Alabama United States Senate seat vacated by Jeff Sessions when Sessions became U.S Attorney General. Trump supported Strange’s effort to win election to the seat in his own right for the term to commence after the interim appointment expired. Big Luther is, indeed, big. At six feet, nine inches, he is the tallest U.S. Senator ever. But Strange lost the Republican primary to Judge Roy Moore, and then Moore went on to lose to Doug Jones.

Sometimes we forget that state attorneys general also – at least usually – had careers as working attorneys who handled the same sorts of discovery and motion issues that fill up the days of most of us. Strange was a lawyer for an important energy company (full disclosure: we represented that same company many years ago), and was once a partner at one of Alabama’s preeminent law firms.

And it turns out that Strange is also an impressive legal scholar. He is the author of “A Prescription for Disaster: How Local Governments’ Abuse of Public Nuisance Claims Wrongly Elevates Courts and Litigants into a Policy-making Role and Subverts the Equitable Administration of Justice,” 70 South Carolina L. Rev. 517 (Spring 2019). It is a useful and good read, and it is not our aim to steal Strange’s thunder. Consider our little summary an invitation to go to the article, study its citations, and follow its argument.

Strange makes the point that nuisance actions originated in criminal law, with the prosecution of such claims reserved for state or government officials seeking injunctive relief or criminal conviction for harms to the public. Strange then traces the evolution and expansion of the theory, with specific allusion to municipal suits against the gun industry for violent crimes, against the oil industry for climate change, and against banks and lenders for subprime lending practices. The last episode outlined in the historical section of the article is the opioids litigation. Strange distinguishes a state AG’s parens patriae authority from local governments, which have authority to recover only for injuries suffered by the municipality/county/whatever itself. It is the latter species of action that troubles Strange.

Strange’s fundamental criticism of local government actions against alleged public nuisance is that they inject litigants and courts into democratic policy-making decisions. He does not favor regulation by litigation, and warns that it implicates separation of powers concerns. Regulatory lawsuits invade legislative powers, and courts are not particularly good at such regulation. Moreover, the subject of the proposed judicial regulation will often be a nonjusticiable political question, which was committed to a coordinate government branch, eludes judicial standards, reeks of policy determinations, and creates the possibility of multifarious pronouncements by different organs of government. Legislatures and regulators possess technical expertise that courts (and juries) lack, and are also peculiarly capable of balancing cross-cutting policy interests.

There are, of course, legal doctrines that should step in and halt lawsuits that infringe upon regulatory regimes. Any reader of this blog will have bumped into dozens of posts about preemption and primary jurisdiction. Strange takes those doctrines seriously – certainly more seriously than the many rogue courts that seem to view them as inconveniences. Wyeth v. Levine is appropriately cabinned by the article. Primary jurisdiction gets the respect it deserves in this article, as does the dormant commerce clause. Strange also sets out how public nuisance suits allege damages that are not traceable to and proximately caused by the defendants’ conduct – with such conduct usually being lawful under the applicable regulatory regime.

The article also makes the point that local government actions disrupt the ability of state attorneys general to bring and manage litigation arising from the same alleged conduct. The actions might be beyond the scope of local governmental authority. Even if within scope, the local government actions raise the specter of double recovery.

Aside from doctrinal barriers and practical dangers, local government suits adversely affect the administration of justice in other ways. Strange describes how the various layers of redundant suits can multiply discovery requests, enable outlier verdicts to distort the overall litigation process, and penalize defendants for conduct occurring outside the relevant jurisdiction.

Anyone who has played a role in local government nuisance litigation will recognize the force of Strange’s insights. The system is messy and sometimes yields unfair results. As is always the case, there are winners and losers. Predatory plaintiff lawyers and policy-making judges seem to think the system is just fine. But Strange makes a compelling case that judicial administration is a loser, as is the regulatory function that weighs costs and benefits for society as a whole.

We all know hindsight is 20/20.  And, it’s easy.  There are dozens of television and radio programs that thrive on Monday morning quarterbacking.  There’s no risk in saying the coach should have called for a pass when you already know the run didn’t work.  It’s also dangerous because it’s easy.  People are often too quick to point out that you should have taken path B after everyone learns path A is full of potholes.  Pointing it out is one thing, holding you liable for it is another.

What does hindsight mean in the products liability arena? Unfortunately, it can be used to demand perfection.  It can be used to allow plaintiffs to proceed on what is essentially a stop-selling theory based on the fact that in hindsight later approved treatments were safer.  That’s what happened in Holley v. Gilead Sciences, Inc., 2019 WL 2077845 (N.D. Cal. May 10, 2019).

Gilead is the manufacturer of several drugs used to treat and/or prevent contraction of the AIDS virus.  Several contain as their active ingredient tenofovir disoproxil fumarate (“TDF”).  The TDF drugs were approved by the FDA between 2001 and 2012.  Certain other of Gilead’s AIDS medications contain tenofovir alafenamide fumarate (“TAF”) rather than TDF.  The TAF drugs were approved by the FDA in 2015 and 2016.  Plaintiffs allege that defendant failed to provide adequate warnings with the TDF drugs regarding the increased risk of kidney and bone damage.  Plaintiffs also claim that defendant should be liable for “its decision to develop drugs containing TDF rather than the safer compound [TAF].”  Id. at *1.  At the heart of this claim is an allegation that the defendant was aware of TAF and that TAF was safer before it started selling TDF.  Id. at *2.

Defendant moved to dismiss all counts on federal preemption grounds.  Plaintiffs’ primary design defect claim was that there was a safer alternative available at the time defendant sought FDA-approval for the TDF drugs.  Id. at *7.  So, plaintiffs’ argument is that defendant never should have brought TDF to market.  But never-start selling claims based on allegations that the defendant should never have submitted the product to the FDA should be preempted as disguised “stop-selling” claims.  See Yates v. Ortho-McNeil Pharmaceuticals, Inc., 808 F.3d 281, 300 (6th Cir. 2015); Utts v. Bristol-Myers Squibb Co., 226 F. Supp. 3d 166 (S.D.N.Y.  2016); and Brazil v. Janssen Research & Development LLC, 196 F. Supp.3d 1351, 1364 (N.D. Ga. 2016).  But the Holley court did not see it that way.  Where Holley misses the point, however, is its focus on some hypothetical pharmaceutical product rather than the one at issue in the case.  To even state a design defect claim, plaintiffs have to identify a defect in the product they used – the one that was sold and marketed.  The court is correct that there is no federal law that prevents a manufacturer from developing a drug different from the one at issue.  Id. at *9.  That would be silly.  The fact that it did so at a later date, however, can’t be used to second guess the FDA’s approval of the drug at issue.

The danger of drawing an artificial distinction between pre and post approval is even more clearly seen in plaintiff’s argument that one of its TDF products should have contained a lower dose of TDF.  That argument could be made of almost any drug.  And post-approval, the design claim is preempted by Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013).  Pre-approval, it’s not?  We’ve argued time and again that a different product isn’t a safer alternative design.  Neither is it by-pass around preemption.

Holley doesn’t stop there, unfortunately.  To the contrary, it extends “pre-approval” claims to warnings as well as design.  To do that, it first had to discount the body of law that has interpreted Wyeth v. Levine as preempting failure to warn claims based on “information known to the FDA.” Id. at *11 (citations omitted).  That is why claims regarding the adequacy of a drug’s label at the time of approval are preempted.  That label was reviewed and approved by the FDA and the jury can’t be used to second guess that approval.  What a manufacturer can/should do with its label post-approval based on information not presented to the FDA is a different question.  So what is a pre-approval failure to warn claim anyway?  An allegation that the manufacturer should have submitted a different warning or different information to the FDA for approval?  That sounds an awful lot like fraud-on-the-FDA, which is Buckman preemption.  So, the fiction of calling plaintiffs’ claim a pre-approval failure to warn claim should not have saved it.

After allowing the pre-approval claims, the court did have to find that at least some of plaintiff’s post-approval warning claims were preempted due to lack of newly acquired evidence.  Id. at *11-12.  The “newly acquired information” requirement for CBEs wasn’t added until 2008.  So, for the older drugs, defendant could have changed the warning regardless of whether it had such new information; those claims aren’t preempted.  Id. at *12. Post-2008, plaintiffs point to different types of post-marketing information regarding the risks of TDF drugs.  But, they failed to plead whether and to what extent that information was provided to the FDA.  Therefore, the court could not determine what was “newly acquired evidence” that would support a CBE; those claims were preempted.  Id.  But dismissal is without prejudice as the court found there was a likelihood the deficiency could be cured.

Moving outside of preemption, defendant did make a few TwIqbal arguments.  First, warning causation.  Here the court said plaintiffs met the pleading standard by alleging that physicians would have “acted differently.”  Id. at *13.  So, an allegation that the prescriber would have monitored plaintiff more closely sufficed, as opposed to the prescriber would not have used the drug.  Second, consumer fraud.  Apparently, in this part of California, pleading of some consumer fraud claims doesn’t have to meet Rule 9(b).  Where plaintiff’s consumer fraud claim alleges “some fraud” and “some non-fraudulent conduct” – only the fraud is subject to Rule 9(b).  So, does that mean you can dismiss half a claim under a TwIqbal?  Here, the portion of the claim based on allegations that defendant acted “unfairly” instead of fraudulently weren’t subject to heightened scrutiny.  The court also didn’t dismiss plaintiffs’ omission based claims, but did dismiss without prejudice their misrepresentation claims.

A hindsight-oriented opinion on hindsight claims alleging that first-generation drugs should not have even been submitted to the FDA because later treatments were safer.  The logic is flawed because it’s based on Monday morning quarterbacking which should be left to sports commentators and ticked-off fans; not to judges and juries.

Just in.  United States Supreme Court rules unanimously in Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290, slip op. (U.S. May 20, 2019) (“Albrecht”), that the Third Circuit got it wrong in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017).  However, the majority opinion, by Justice Breyer, is limited and draws the support of members of the Court who are usually anti-preemption.  That says two things.  First, the Third Circuit was so far off the wall that its extreme anti-preemption position could not be stomached by anyone.  Second, if the analysis had been by a generally pro-preemption majority, rather than one with the opposite inclinations, the reasoning could have been a lot better.

Because the majority opinion has the votes of Thomas, Ginsberg, Sotomayor, Kagan and Gorsuch, it is limited to cleaning up the Third Circuit’s mess and does not decide the ultimate question of preemption on the existing facts.  Albrecht, slip op. at 17 (vacating and remanding, but not deciding the underlying preemption decision).  Once again (as with Wyeth v. Levine, 555 U.S. 555 (2009)), the “facts” are surprisingly malleable.  The majority (for reasons we’ll get into) omits a great deal of the regulatory history, and are called to task for that in Justice Alito’s concurring opinion (for Roberts, C.J., and Kavanaugh).

First, the Albrecht majority offers a more detailed definition of “clear evidence” under Wyeth v. Levine, 555 U.S. 555 (2009), rejecting the Third Circuit’s “clear and convincing” standard:

“[C]lear evidence” is evidence that shows the court that the drug manufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.

Albrecht, slip op. at 1-2 (emphasis added); see also id. at 13 (satisfying this test would “show[] that federal law prohibited the drug manufacturer from adding a warning that would satisfy state law”).  This definition avoids situations where the FDA was “fully informed” (or not) by someone else, such as through a third-party Citizen’s Petition.  The majority doesn’t reach facts not before it.  See id. at 12 (emphasizing importance of “record” facts).

The dividing line for preemption in branded prescription drug cases continues to be whether the provisions of the FDA’s “changes being effected” (“CBE”) regulation are satisfied by the facts of the case.  Id. at 3-4, 14.  That regulation requires “newly acquired information” and, further, “manufacturers cannot propose a change that is not based on reasonable evidence.”  Id. at 14 (citing various parts of CBE regulation).  However, “in the interim, the CBE regulation permits changes, so a drug manufacturer will not ordinarily be able to show that there is an actual conflict between state and federal law such that it was impossible to comply with both.”  Id.  But what about what was done here – a Prior Approval Supplement (“PAS”), which is an alternative to a CBE label change?  Very little was said about that by the majority.

Second, the majority ruled that preemption – as had always been the case before Fosamax, remains a question “primarily of law” for courts, not juries, to decide.  “We here decide that a judge, not a judge, must decide the pre-emption question.”  Id. at 9.

[T]he question is a legal one for the judge, not a jury.  The question often involves the use of legal skills to determine whether agency disapproval fits facts that are not in dispute.  Moreover, judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination. . . .  And judges are better suited than are juries to understand and to interpret agency decisions in light of the governing statutory and regulatory context.  To understand the question as a legal question for judges makes sense given the fact that judges are normally familiar with principles of administrative law.  Doing so should produce greater uniformity among courts; and greater uniformity is normally a virtue when a question requires a determination concerning the scope and effect of federal agency action.

Albrecht, slip op. at 16 (citations and quotation marks omitted).  Whatever factual questions might exist in a particular case are “subsumed within an already tightly circumscribed legal analysis” and decided by the judge.  Id. at 17.  So that issue’s over with.

Third, as a consequence of preemption being a legal question, the Albrecht majority also eliminated the Third Circuit’s peculiar “clear and convincing evidence” standard as superfluous:

We do not further define [Levine’s] use of the words “clear evidence” in terms of evidentiary standards, such as “preponderance of the evidence” or “clear and convincing evidence” and so forth, because, . . . courts should treat the critical question not as a matter of fact for a jury but as a matter of law for the judge to decide.

Albrecht, slip op. at 14.  Rather, “the judge must simply ask himself or herself whether the relevant federal and state laws irreconcilably conflict.”  Id. (citation and quotation marks omitted).  FDA action establishing preemption may occur by “notice-and-comment rulemaking,” “formally rejecting a warning label,” or any “other agency action carrying the force of law.”  Id. at 15 (citing, inter alia, 21 U.S.C. §355(o)(4)(A), concerning FDA acting on its own accord).

Albrecht was necessary because the Court did a lousy job in Wyeth v. Levine, 555 U.S. 555 (2009), articulating what it held about impossibility preemption.  For the last decade, courts have struggled to apply a counterfactual preemption standard requiring “clear evidence” – an undefined term − that FDA “would have” rejected a proposed warning change that in fact was never submitted.  Post-Levine decisions have been all over the lot about how strictly to apply Levine’s “would not have approved” standard.

But in Albrecht, the FDA had actually refused to allow a warning about the risk at issue.  Piling absurdity on top of absurdity, the Third Circuit had denied preemption even then – where the FDA actually rejected what plaintiffs demanded – making impossibility preemption truly impossible.  Fosamax, as it was called before reaching the Supreme Court, was awful enough that we ranked it the worst decision of the year in 2017.  Not surprisingly, the defendant sought certiorari in the Supreme Court.  The FDA agreed on how badly the Third Circuit had erred, and the Solicitor General filed supporting amicus briefs, both on the writ and on the merits.  In the Supreme Court, the Third Circuit’s rationale could not garner even one vote.

The Supreme Court also agreed (at least sub silentio) that Levine was poorly reasoned.  Albrecht spent an extraordinary four pages of the opinion just “describing [Levine],” Albrechtslip op. at 10-13, which would hardly have been necessary had Levine made more sense.  We note that, conspicuously absent from that description is any express reference to any “presumption” (as opposed to the older “assumption”) against preemption.

In addition to the main points above, another highlight of the Supreme Court’s decision in Albrecht is express recognition of “overwarning” as a reason for the FDA’s labeling requirements:

The hierarchy of label information is designed to “prevent overwarning” so that less important information does not “overshadow” more important information.  It is also designed to exclude “[e]xaggeration of risk, or inclusion of speculative or hypothetical risks,” that “could discourage appropriate use of a beneficial drug.”

Albrecht, slip op. at 3 (quoting 73 Fed. Reg. 49603, 49605-06 (Aug. 22, 2008) & 73 Fed. Reg. 2848, 2851 (FDA Jan. 16, 2008)).

Justice Thomas’ concurring opinion explains some of the oddities of the Albrecht decision.  Basically, he doesn’t accept an FDA “complete response letter” as a form of “law” that can be preemptive.  Albrecht, slip op. at 5 (“the letter was not a final agency action with the force of law, so it cannot be ‘Law’ with pre-emptive effect”) (Thomas, J. concurring).  We think that’s why the majority’s discussion of the regulatory history of Fosamax, compared to the concurrence, is so limited.  There is a lot of regulatory activity in between actual FDA actions.  To get Thomas’s vote, the majority omitted it.  Justice Thomas didn’t like what the Third Circuit had done, but wasn’t a pro-preemption vote either.  On that issue, Justice Thomas wrote only for himself.

Justice Alito (plus Roberts, C.J., and Kavanaugh) concurred only in the result because of “concern that its discussion of the law and the facts may be misleading on remand.”  Albrecht, slip op. at 1 (Alito concurrence).  Most of this objection has to do with the majority’s slanted version of the facts, id. at 4-5, something that also recalls Levine, and not in a good way.  However, the concurrence also highlights §355(o)(4)(A) – which as we noted was merely cited by the majority – because “if the FDA declines to require a label change despite having received and considered information regarding a new risk, the logical conclusion is that the FDA determined that a label change was unjustified.”  Id. at 2.  The concurrence would go further than the majority, addressing the “who else” question under this section:  “The FDA’s duty does not depend on whether the relevant drug manufacturer, as opposed to some other entity or individual, brought the new information to the FDA’s attention.”  Id.  Conversely, on the actual facts before the Court in Albrecht, Justice Alito was nonplussed by the majority’s failure to discuss the “Prior Approval Supplement” route of changing warnings.  Id. at 3-4.

Justice Alito agrees with the majority that Levine’s use of “clear evidence” was “merely a rhetorical flourish.”  Id. at 3.  “Standards of proof, such as preponderance of the evidence and clear and convincing evidence, have no place in the resolution of this question of law.”  Id.

So now what?

The one thing that’s definitively been put to bed by Albrecht is the notion of preemption as a question of fact to be decided by juries.  That is gone, and Albrecht’s ruling on this point will apply to all forms of implied preemption no matter what the product, since implied preemption is trans-statutory.  Also gone is the notion of a “clear and convincing” evidence standard.

If one is seeking clarity, that is as far as Albrecht will take you.  “Clear evidence” now has a new, post-Levine definition, but as Justice Alito discussed, that definition has some issues with it – most significantly with respect to the role of Citizen’s Petitions.  As for the redefined “clear evidence” standard, plaintiffs will be henceforth argue over what it means to “fully inform” the FDA.  OK, but not cited anywhere in Albrecht was Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), which has a lot to say about what plaintiffs can and can’t assert about sufficiency of submissions to the FDA.  The FDA also has to act for there to be “clear evidence,” but that’s been less of an issue historically, as Levine pretty much ended FDA inaction cases.  Another thought we have is that Albrecht has next to nothing to do with design defect claims, since there is no CBE regulations for design changes.

More than anything else, Albrecht reminds that Justice Thomas has very quirky views on preemption.  Even in a case like this one, where the anti-preemption position of the circuit court was way out in left field, there are reversals and there are reversals.  Albrecht is the kind of reversal that leaves both sides with only half a loaf.


To the surprise of almost nobody, the Centers for Medicare & Medicaid Services finalized their proposed direct-to-consumer advertising regulation the other day.  That’s the one that would require a statement of the promoted drug’s “list price” in all DTC advertising.  We’ve already discussed why we thought the regulation was on shaky ground in terms of CMS’s authority to issue it, and in terms of the First Amendment.  The final rule doesn’t seem to have changed anything in terms of the former, so we won’t re-examine the authority question, except to note one thing – Congress could fix that problem at any time through legislation expressly granting CMS the authority it currently seems to lack.

As to the First Amendment, we find risible the government’s position that “list price” isn’t “controversial” in the context of prescription drug pricing.  Here’s the regulation’s definition:

Wholesale acquisition cost.  Wholesale acquisition cost means, with respect to a drug or biological, the manufacturer’s list price for the drug or biological to wholesalers or direct purchasers in the United States, not including prompt pay or other discounts, rebates or reductions in price, for the most recent month for which the information is available, as reported in wholesale price guides or other publications of drug or biological pricing data.

(Emphasis added).  This definition is facially controversial, since it demands that the advertiser “not includ[e] prompt pay or other discounts, rebates or reductions in price.”  In blunt terms, the advertiser is being expected to mislead most, if not all, of its target audience by using a product price that is too high, since most of us drug consumers benefit from “discounts, rebates or reductions in price.”  The folks currently running CMS may not like it, but most Americans still have health insurance.  Most tellingly, CMS concedes the point, admitting that “where the consumer may be insured” s/he “therefore will be paying substantially less than the list price.”

This regulation is odd in other respects than government mandated lying (we will refrain from further political comment).  In terms of enforcement, it’s essentially toothless.  Here’s the only “compliance” provision:

 403.1204 Compliance.

(a) Identification of non-compliant products.  The Secretary shall maintain a public list that will include the drugs and biological products identified by the Secretary to be advertised in violation of this subpart.

CMS will put you on a list.  Big whoop.  And even that’s not hard to avoid.  We can see it now – a DTC advertisement that ends with:

List Price:

Any Single

Price Would Be


See our website, for full pricing and cost details.

On the referenced website, the advertiser provides every bit of actual pricing information available, perhaps offering customers assistance in navigating the healthcare system to obtain particular prices.  In a bit of delicious irony, to help consumers get the best prices, the advertiser could even choose to assist with Obamacare sign ups.  After all, if CMS can now require DTC drug advertisements to state one thing, then a different administration’s CMS could mandate that such advertisements assist the public in participating in the very programs that CMS administers.  Sauce for the goose….

The CMS rule also suggests that private Lanham Act actions could assist enforcement.  Good luck trying to convince anyone that the hypothetical above (and many other possibilities) is “misleading” so as to create liability under that statute.  It’s likely more accurate than what CMS is seeking, and in any event it’s sufficiently accurate that competitors aren’t going to waste attorney fees on Lanham Act litigation with little chance of success.

As product liability litigators, however, we are most interested in anything that preempts state-law tort suits.  This regulation comes with an express preemption clause:

(b) State or local requirements.  No State or political subdivision of any State may establish or continue in effect any requirement that depends in whole or in part on any pricing statement required by this subpart.

403.1204(b).  We’ve seen that before.  It’s patterned on 21 U.S.C. §360k(a), the preemption clause for the Medical Device Amendments.  Thus, this preemption language includes state tort suits, and being express, is not subject to any presumption against preemption.  Recognizing the above caveat concerning CMS having any authority at all in this area, if it does, then many decisions have held that administrative regulations also have the same preemptive effect as statutes.  E.g., Geier v. American Honda Motor Co., 529 U.S. 861, 872 (2000).

So the preemption clause provides that any state-law tort claim is preempted if it “depends in whole or in part on any pricing statement required by this subpart.”  We refer back to the definition of “wholesale acquisition cost” (“WAC”) we quoted above.  Under this preemption clause, it doesn’t matter what context – private tort suit, private consumer fraud suit, or state enforcement action – if a claims “depends” even a little bit on anything having to do with WAC, then preemption should whack the action.  We think the preemption clause is sufficiently broadly worded to encompass both how WAC is calculated and how it is disseminated.

To sum up, we think:

  • CMS probably doesn’t have authority to do this.
  • If it does, this exercise probably violates the First Amendment.
  • If it’s constitutional, it’s damn near toothless.
  • But, in any event, it gives us defense lawyers another preemption clause to assert.

As a young associate, we worked for a short time with then soon-to-be-Judge Harvey Bartle. We remember that, although kind and very funny, then-lawyer Bartle had a no-nonsense approach to law practice and a keen ability to discern the correct answer, sweeping aside fluff and obstacles en route to what made sense. We were excited when his appointment to the federal bench was announced. A few months later, we even asked Judge Bartle to perform our wedding (we almost said, “asked him to marry us,” but that wasn’t going to come out right) and were disappointed to learn that he would be out of town for the big day.

And so we were pleased, but unsurprised, to observe that Judge Bartle authored the decision on which we report today. We are told that a Westlaw cite will be forthcoming, but you can find the decision and order, respectively, at Documents Nos. 288 and 289 in the Zostavax MDL, In re Zostavax (Zoster Vaccine Live) Products Liability Litigation, E.D. Pa., MDL No. 2848, Civil Action No. 2:18-md-02848-HB. We have linked the documents here and here. We have blogged previously on the Zostavax MDL, and you can read those posts here.

Today’s opinion is a decision on Merck’s motion to dismiss 173 plaintiffs’ claims for fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, violations of state consumer fraud statutes, and on a motion by co-defendant McKesson (a distributor) to dismiss the entire complaint in each of the 173 cases. As he and transferor courts had in four earlier individual cases, Judge Bartle granted Merck’s motion to dismiss the fraud-based claims, including the consumer fraud claims, with prejudice, holding that none had been pled with the particularity required by Fed. R. Civ. P. 9(b), despite several opportunities to amend. Judge Bartle stated. “Each of the 173 complaints is full of boilerplate language unrelated to the individual case and is the antithesis of how a proper federal complaint should be drafted. The one-size-fits-all approach of plaintiffs’ counsel produced allegations that are absurd on their face as to every plaintiff.” Opinion, at 2. These absurdities included allegations that plaintiffs “were induced to obtain a Zostavax vaccination by advertisements that began running years after plaintiffs were inoculated.” Id. at 3. Judge Bartle commented, “Plaintiffs’ counsel has habitually made such improper allegations, and the court has previously granted motions to dismiss nearly identical claims with prejudice,” id., and that, “[d]espite the court’s strong language chastising plaintiffs’ counsel” in those decisions, “counsel [had] continue[d] its vexatious behavior.”   Id. In light of those earlier decisions, the defendants had asked the plaintiffs’ counsel to dismiss these claims from the 173 cases, but plaintiffs’ counsel refused. The court “reiterated that such behavior can only be designed to waste the time and resources of the court and opposing counsel.

With respect to McKesson’s motion to dismiss the entire complaints in each of the 173 cases, Judge Bartle dismissed the fraud-based claims with prejudice, and the remaining counts without prejudice “on the ground that plaintiffs have failed to satisfy the requirements of Rule 8(a) of the Federal Rules of Civil Procedure,” id, by filing complaints in which the “deficiencies” were “manifest” and that did not contain “a short and plain statement of the claim showing that” the plaintiffs were “entitled to relief.” Id. The court also, sua sponte, dismissed the remaining claims without prejudice as to Merck, to avoid the “unmitigated confusion” that would result if different complaints were pending against the two defendants. Id. at 4. In closing, the court “urge[d]” plaintiffs’ counsel “not to repeat the same behavior here with respect to any future filings” in the MDL. Id. at 4-5.

But that wasn’t Judge Bartle’s final punch. In his separate Pretrial Order (the second of our linked documents), the judge ordered that re-filed amended complaints not exceed 40 pages. He then called out a plaintiffs’ firm by name, ordering that firm never to file another complaint or amended complaint longer than 40 pages and stating that any overlength pleading would be dismissed “without prejudice on [the court’s] own motion.” Pretrial Order No. 172, at 2.

We spend much of our professional life in the largely-unchecked world of MDL “master complaints” that list dozens and dozens of possible claims, and of plaintiffs’ lawyers who “incorporate” every single claim into every single short-form complaint filed on behalf of an individual plaintiff. Facilitating the MDL “cattle call” mentality in which plaintiffs’ firms assemble “inventories” of hundreds or thousands of cases without ever meeting the individual plaintiffs, this regime has never made a bit of sense and has allowed plaintiffs’ complaints to become procedural exercises lacking all significance. It has also permitted cases to remain pending for years and years during which no one – least of all the plaintiffs themselves – have any idea what the “real” claims are, let alone whether any claim has merit. We have lost track of the number of times we have expressed, in these pages, our frustration at the resulting MDL “parking lots.”

So we would love this decision even if it didn’t involve a bit of our professional history. The fact that it evokes decades-old memories of a fresh-faced associate only makes it sweeter. We are sure there is more to come in the Zostavax MDL, and we will keep you posted.

Bexis is going to have to give up saying that nothing good ever comes out of Missouri, because for the second time in just a few months we are reporting on a well-reasoned opinion from Missouri that comes to the right result for the right reasons.  In Fullerton v. Smith & Nephew, Inc., No. 1:18-cv-245, 2019 U.S. Dist. LEXIS 77350 (E.D. Mo. May 8, 2019), the district court dismissed all claims against a Tennessee-based medical device manufacturer on the basis that the Missouri-based court lacked personal jurisdiction.

There are a couple of interesting things about this order.  But first, what happened?  The plaintiff underwent a hip procedure in Arkansas using the defendant’s device, and the hardware allegedly failed, resulting in a second procedure to remove the device.  Id. at *2.  The defendant was a citizen of Delaware and Tennessee, but the plaintiff sued in Missouri.  Id. at *2-*3.  The plaintiff was a Missouri resident, so this is not a case of blatant litigation tourism that Missouri’s courts see all too often.

Regardless, because the defendant was not “at home” in Missouri and because there was no nexus between the tort and Missouri, the defendant moved to dismiss for lack of personal jurisdiction.  Id. at *3.

It was undisputed that the court did not have general jurisdiction over the defendant because Missouri was not the defendant’s home state.  Id. at *5.  The plaintiff therefore offered up two theories of specific jurisdiction:  First, the plaintiff asserted that the court had specific jurisdiction because the defendant sought to do business in Missouri by registering to do business with the Missouri Secretary of State.  Second, the plaintiff argued that although the device was implanted in Arkansas, the tort occurred in Missouri, where the device allegedly malfunctioned.  Id. at *5.

The district court rejected both arguments, and there are two points that we would emphasize.  First, although the plaintiff attempted to base specific jurisdiction on the defendant’s registration with the Missouri Secretary of State, he acknowledged that registering to do business and maintaining a registered agent alone do not create personal jurisdiction.  Id. at *8.  Corporate registration is often asserted as a basis for general jurisdiction, but the Missouri Supreme Court has already rejected that position.  The plaintiff in Fullerton therefore added that the defendant “has a long standing history of conducting business in Missouri and sells an ‘enormous amount’ of products in Missouri on a daily basis.”  Id. at *9.

Do those alleged facts sound familiar?  They should, because those were the facts in the U.S. Supreme Court’s landmark case on specific jurisdiction, BMS v. Superior Court, 137 S. Ct. 1773 (2017).  The defendant in BMS allegedly sold lots of product in California for patients other than the plaintiffs.  But according to the U.S. Supreme Court, even a defendant’s “extensive forum contacts” cannot support specific jurisdiction if they are unrelated to the plaintiff’s claims.  Id.  Any other approach would resemble a “loose and spurious form of general jurisdiction.”  Id.

The district court in Fullerton followed BMS and rejected specific personal jurisdiction based on the defendant’s allegedly “enormous amount” of unrelated business in Missouri:

Simply stating that a company marketed, promoted, and sold a product in Missouri does not establish specific jurisdiction.  Indeed, “[t]he inquiry into specific jurisdiction does not focus on Plaintiff’s contacts with the forum state, but Plaintiff’s injury must be connected to Defendant’s contacts with the forum state.”

Id. at *9-*10 (citing cases including Keeley v. Pfizer, Inc., No. 4:15CV00583 ERW, 2015 U.S. Dist. LEXIS 85282, 2015 WL 3999488, at *3 (E.D. Mo. July 1, 2015)).  That is where the plaintiff’s case for specific jurisdiction failed:  It was not relevant that the defendant sold products for other patients in Missouri.  The defendant had to have sold the plaintiff’s product in Missouri.

Bexis recently proposed a simple test to determine specific jurisdiction under BMS:  If the claimed forum contact could be asserted by any plaintiff, no matter where that plaintiff resides, was injured, etc., then it’s not the kind of contact that makes a claim “arise from” or “relate to” the forum state.  The plaintiff’s alleged forum contacts in Fullerton fail this test spectacularly.  Anyone, anywhere could assert that the defendant sells “an enormous amount” of product in Missouri.  That, however, is not relevant.  The plaintiff had to come up with “case-linked” Missouri contacts, and he could not.

That leads to the second interesting part of the Fullerton order.  This plaintiff argued also that the product was implanted in Arkansas, but that it allegedly malfunctioned in Missouri, which meant that a tort was committed in Missouri.  Nice try, but what does that have to do with the Defendant’s forum contacts?  “While Plaintiff maintains that he was a resident of Missouri when the tort occurred, the medical device at issue was manufactured in Tennessee, shipped to Arkansas, sold in Arkansas, and implanted in Arkansas.”  Id. at *10.  In other words, the complaint was devoid of any specific facts indicating that the plaintiff’s claim “arises out of and relates to the Defendant’s activities in the State of Missouri.”  Id. at *10-*11.

In the end, “[n]one of the facts alleged by Plaintiff connect [the defendant’s] conduct in Missouri to Plaintiff’s injury.”  Id. at *11.  The court therefore lacked personal jurisdiction.  As we said at the outset, the right result for the right reasons.

There are more bad fraudulent joinder decisions than good ones out there, and we typically do not like publicizing the other side’s wins. But occasionally an opinion is so weird that it merits a brief comment. Cardoza v. Med. Device Bus. Servs., 2019 U.S. Dist. LEXIS 77506 (W.D.Va. May 8, 2019), is a bit weird. The plaintiff was a Virginia resident who alleged that the liner of her hip implant fractured shortly after being implanted, requiring her to have emergency revision surgery. Because some of the fractured pieces could not be removed, she continues to have shards in her body. She sued in Virginia state court, naming five out-of-state defendants, all of whom have some relationship to the development, manufacture, or distribution of the hip implant and/or the liner, while also naming three Virginia defendants. What’s weird about any of that? It sounds like a run of the mill product liability case, doesn’t it?

Not completely. In addition to the product liability claims, the plaintiff also asserted three additional state-law claims: a “spoliation” claim; a claim for wrongful disclosure of medical information; and conversion. Those claims arose out of her allegation that, despite her surgeon’s pre-surgery assurances that he would give her the parts of the implant that were removed, those pieces were not provided to her, but were instead given to the manufacturing defendants, where they were “examined, inspected, and tested.” Although the parts have since been returned to her, she alleged that their condition and the lack of any information about the chain of custody makes it “virtually impossible for [her] to determine with reasonable certainty the root cause of her injuries and damages.”

The out of state defendants removed the case to federal court on the basis of diversity jurisdiction. The plaintiff moved to remand. Predictably, the plaintiff argued that the existence of the Virginia defendants destroyed diversity jurisdiction and required remand. Equally predictably, the out of state defendants countered that the non-diverse defendants were fraudulently joined because the plaintiff had no possibility of succeeding on the two counts in which they were named: wrongful disclosure of medical information, and conversion.

The plaintiff offered a threshold argument that remand was required because of technical violations of the removal statute, involving failures to attach copies of all process and pleadings in the case, as well as failure to give requisite notice. But no Fourth Circuit decision suggested that any such technical flaws invalidated removal, and the district court concluded that all that was afoot were de minimis violations that can be cured. We hope the defendants savored this victory, because it just gets worse after that.

The court concluded that, at least as to one claim against one of the non-diverse defendants, the conversion claim, the defendants “cannot show that there is no possibility of establishing the cause of action.” Still, the defendants did not go down without a fight. They relied on a consent form signed by the plaintiff prior to her surgery in which she consented in writing to the hospital doing what it pleased with the explanted parts. But the court held that it could not consider documents beyond the pleadings. The plaintiff claimed that she and her surgeon had a mutual intent to modify a term of the written agreement. Based on that, the court refused to say on the current record that defendants showed that the plaintiff had “no possibility” of succeeding on her claim.

The out of state defendants’ alternative argument was that, even if the non-diverse defendants were not fraudulently joined, the claims against them were improperly joined with the claims against the diverse defendants. This is a theory of “fraudulent misjoinder.” The court held that the plaintiff’s ability to prove her claims against the diverse defendants was “intertwined with her allegations regarding the conversion and spoliation of the extracted implants.” Thus, the court did not find that the claims against the non-diverse defendants were fraudulently misjoined. Lastly, as if to put a poisoned cherry on top of this rotten sundae, the court held that even if it had the discretion to sever, it would not do so here.

Anytime we start to write a post about a decision from New York, our heads start swimming in music lyrics.  Rose trees never grow in New York City…  Concrete jungle where dreams are made of…  Living just enough for the city…  Soon you will be on Sugar Hill in Harlem…  I don’t care if it’s Chinatown or on Riverside… Mom’s cookin chicken and collard greens…  Not only are there simply so many songs written about or inspired by New York, there are so many excellent songs written about or inspired by New York.  From Stevie Wonder to U2 to Paul Simon to the Beastie Boys and the list goes on . . . . Joel, Sinatra, Croce, Waits, Gershwin, Cohen . . .

As well as New York is known for its sound, our real goal today is to remind you it should also been known for its statute of limitations.  The opportunity to remind you is brought to us by the Second Circuit in Baker v. Stryker Corp., 2019 U.S. App. LEXIS 13869 (2nd Cir. May 9, 2019).  Plaintiff had a dental device implanted in August 2006 and in May 2016 filed suit alleging negligence, strict liability, and breach of warranty against the manufacturer.  Plaintiff’s sole argument was that he could not have discovered his injury until his first implant was removed in 2013.  Id. at *4.  But, that’s not the law in New York.  From the Battery to the top of Manhattan…  Actually from Tottenville to Massena since it’s the law of the state.

New York’s statute of limitations for products liability is three years and that starts to run from the date of injury.  Id. at *2-3.  That means the statute starts to run “when plaintiff first noticed symptoms, rather than when a physician first diagnosed those symptoms.”  Id. at *3.  So, it didn’t matter what the doctor diagnosed when he removed the implants.  The important facts are that plaintiff testified he started feeling pain within days of when the device was implanted in 2006.  He described the pain as “radically different from the pain he experienced” in earlier surgeries and that he also felt a choking sensation.  Id. at *3-4.  Therefore, his personal injury claims accrued in August 2006 and were time-barred.  New York where hustle’s the name of the game.

In New York, the discovery rule that plaintiff tried to rely on only applies to latent exposure cases.  See C.P.L.R. §214-c.  In other words, it was meant for toxic torts.  Baker at *5.  But even if it did apply, “discovery” is defined as “discovery of the physical condition and not . . . the more complex concept of discovery of both the condition and the nonorganic etiology of that condition.”  Id.

Plaintiff’s breach of warranty claim was similarly time-barred because that four-year statute began to run at the time of sale or entry into the stream of commerce.  Id.  So, the latest date of accrual for that claim was at the time of implant which was after the manufacturer sold the device to the hospital.  Id.   The dismissal was affirmed.  It comes down to reality…

And while it’s still a bit cold and dreary in New York right now, we’ll try to conjure up some warm thoughts by ending with — It’s not far, not hard to reach.  We can hitch a ride to Rockaway Beach…

We’ve explained at length why Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), is an anachronism with respect to preemption, given the complete overhaul that Congress gave to §510(k).  Still, strange things happen when preemption meets product liability, and there seems to be a conspiracy of silence among judges with respect to current FDA §510(k) practices and Lohr’s archaic 1982 “grandfathering” process.

But not always.

Thus, today we are discussing Kelsey v Alcon Laboratories, Inc., 2019 WL 1884225 (Utah Dist. April 22, 2019).  The product in Kelsey was contact lens disinfectant, which the plaintiff (predictably) claimed was ineffective in preventing a serious eye infection.  Id. at *1.  We can essentially predict that sort of thing.  Plaintiff at risk of condition X takes something designed to prevent it, and presto, the plaintiff demands that the manufacturer effectively becomes an insurer against whatever that risk might be.

But a funny thing happened in Kelsey on plaintiff’s way to collecting on her ex post facto free insurance claim.


This product was not grandfathered Lohr-style.  Rather it was subject to numerous FDA-imposed “special controls” – specific to this type product.  In particular, FDA had issued “guidance” concerning the applicable FDCA-based requirements:

[T]he FDA issued the Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products (Guidance).  The Guidance “sets forth the general information and special controls FDA believes are needed to assure the safety and effectiveness of contact lens care products. . . .”

Kelsey, 2019 WL 1884225, at *6.  “The Guidance ‘sets forth the special controls which have been determined at this time . . . to be necessary to provide reasonable assurance of the safety and effectiveness of class II contact lens care products.’”  Id. at *7.  We won’t recite the details, but the guidance covered the product’s design, good manufacturing practices, and labeling.  Id. at *7-8.  However, with respect to labeling, the guidance was ambiguous in certain respects:

There is nothing in the Guidance or the Appendix that defines package insert, specifically requires it to be a separate leaflet or pamphlet, or prohibits it from being printed on the inside of the carton.

Id. at *8.

Reviewing both Lohr and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), Kelsey concluded that “there is no automatic preemption” of product liability claims against §510(k) devices.  2019 WL 1884225, at *9.  Rather:

“[S]tate and local requirements are pre-empted only when the [FDA] has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device, different from, or in addition to, the specific Food and Drug Administration requirements.”

Id. (quoting 21 C.F.R. §808.1(d)).  “Special controls” imposed under the current §510(k) process can qualify as preemptive.

Special control documents may provide specific requirements that support a conclusion of preemption of state law claims if they show the federal government has weighed the competing interests relevant to the particular requirement in question, reached an unambiguous conclusion about how those competing considerations should be resolved in a particular case or set of cases, and implemented that conclusion via a specific mandate on manufacturers or producers.

Kelsey, 2019 WL 1884225, at *9 (citations and quotation marks omitted).

In the case of contact lens disinfectant, between a device-specific regulation, 21 U.S.C. §800.10(a), and the aforementioned guidance, there were plenty of preemptive requirements applicable to this device to support preemption.  FDA regulation “forbids a manufacturer from making changes in the design specifications, manufacturing processes, labeling, or any other attribute that could significantly affect the safety or effectiveness of the solution without FDA review, comment, and permission.”  Id. at *10.

Plaintiff tried to escape preemption by arguing that the FDA guidance wasn’t mandatory and only provided “recommendations.”  Id. at *11.  Not a bad argument.  We’ve pointed out the non-binding nature of FDA guidance on numerous occasions.  But it wasn’t the guidance itself, it was the FDA requirements as to which the guidance provided compliance tips that proved preemptive in Kelsey.  “The court disagrees as they relate to the design and manufacture of multi-purpose contact lens solution.  While the Guidance permits some flexibility in how applicants go about demonstrating their solution meets the safety and efficacy requirements, the solution must meet those requirements to be labeled a multi-purpose solution.”  Id.

Who says so?

The FDA in allowing the product onto the market, that’s who:

[A]ccording to the 510(k) Summary, the FDA determined “[b]ased on the results of the comprehensive preclinical evaluations, [the product] is safe for the consumer under the recommended use conditions, as well as under conditions of reasonably foreseeable misuse.”

Id.  Kelsey based its conclusions on a pair of Ninth Circuit decisions, since neither Utah, nor the much smaller Tenth Circuit, had on-point precedent.  Id. at *11-12 (citing Degelmann v. Advanced Medical Optics, Inc., 659 F.3d 835, 838-39 (9th Cir. 2011), vacated due to settlement, 699 F.3d 1103 (9th Cir. 2012), and Papike v. Tambrands Inc., 107 F.3d 737, 740 (9th Cir. 1997)).  “[T]he Ninth Circuit determined the sterility labeling requirement was a device specific regulation because it specifically required a contact lens solution to meet standalone performance criteria to be labeled ‘disinfecting solution.’”  Id. at *11.

As to warnings, Kelsey held that, while the §510(k) requirements could be preemptive, the defendant couldn’t yet muster the record, given the pleadings-restricted nature of a Rule 12 motion to dismiss.  Id.  Plaintiff had a rather odd claim, that turned on the location – rather than the language – of  the relevant warnings:

Plaintiff does not allege that [the product’s] labeling should include different or additional warnings or instructions.  Rather, Plaintiff alleges the warnings and instructions should be included on a “package insert,” which she defines as a separate leaflet or pamphlet inserted in the carton.

Id.  Defendant had instead printed the warning in question on the inside of the package containing the product.  Id. at *3.  The defendant had a bunch of exhibits that (according to it) showed that the inside-the-box warnings satisfied the FDA’s requirements, but the court refused to take judicial notice of them.  Id. at *12.

Further, the guidance wasn’t device specific as to warnings.  “[T]he labeling section of the guideline does not mandate any particular language or warning.  Instead, it provides suggestions’ for language to assist in preparing labeling.”  Id. at *13.  However, some labeling claims might be ultimately be preempted.  Warning claims “would be preempted to the extent . . . based on the label’s inclusion of the words ‘sterile’ or ‘disinfecting,’” but not as to the “claim related to the location of the warnings and instructions.”  Id.  Presumably, plaintiff had figured that out, which is why the unusual locational claim was made in the first place.

Thus, preemption barred the design claims in Kelsey even though the product was §510(k) cleared.  Preemption also could bar some of warning claims, but not the plaintiff’s locational claim.  Preemption also barred claims covered by Good Manufacturing Practices, but not against manufacturing defect claims based on allegations of actual contamination.  Id. at *10-11 & n.73.

While Kelsey involved a product-specific regulation and FDA guidance document, the court also cited to the FDA’s “safety and effectiveness” conclusions made during the clearance process.  That’s progress.  Finally, as a procedural note, Kelsey was not an MDL.  That also means that the built-in institutional biases that make preemption arguments an uphill battle in the MDL context didn’t exist.  We think that’s an apt practice pointer.  There is a reason that we entitled our post that first laid these arguments out, “In Case of Good Judge, Break Glass – Implied Impossibility Preemption in Cases Involving §510(k) Cleared Medical Devices.”