There used to be a TV show called “That Was the Week That Was.”  It was a satirical look at the news of the prior week, but perhaps it’s most lasting accomplishment was to launch David Frost’s career.  Without an ounce of satire, however, we have to say that the business week of August 15 through 19, 2016 was a heck of a week for implied preemption utilizing Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  We’ve already blogged about the Ninth Circuit’s decision in DeBons v. Globus Medical, Inc., ___ F. Appx. ___, 2016 WL 4363171 (9th Cir. Aug. 16, 2016), which invoked Buckman preemption to affirm dismissal of a consumer protection class action that was seeking to recover based on allegations that a medical device wasn’t properly “approved” (but rather cleared under §510(k)) by the FDA.

But DeBons was only one part of that week’s Buckman hat trick.

On the same day, the Fifth Circuit got into the act, affirming a preemption-based dismissal of another medical device product liability suit in Estes v. Lanx, Inc., ___ F. Appx. ___, 2016 WL 4375644 (5th Cir. Aug. 16, 2016).  We’ve already blogged about favorable district court results in the Estes case three times.  The Fifth Circuit affirmed all of them.  Estes involved a spinal fixation system anchored with bone screws, some of which broke under the intense pressures of holding the human body upright.  The screws were explanted and replaced, but “neither the hospital nor [defendant]  retained” them. Id. at *1.

Plaintiff first screamed “spoliation” – he lost.  Id. (“we find no basis for disturbing the district court’s finding of no bad faith”).

Unable to establish a conventional defect without the product, plaintiff tried “fraudulent concealment” instead. That’s where his claim collided with Buckman.  The alleged “fraud” involved how the defendant allegedly presented the device to the FDA:

[Plaintiff’s] claim for fraudulent concealment was premised on the allegation that by submitting component-based applications (rather than a single application) for 510(k) approval for the [device] system, [defendant] violated the Federal Food, Drug, and Cosmetic Act (“FDCA”).

Estes, 2016 WL 4375644, at *2.  Buckman, of course, famously held that there can’t be a private right of action for enforcing FDCA violations, and this claim plainly failed the Buckman preemption test because it could not exist without the FDCA – since there wouldn’t have been an FDA application process at all unless statute existed.  Id. (plaintiff’s “claim is based on the allegation that the system lacked, to use his words, ‘the requisite FDA approval’”; thus, it ‘exist[s] solely by virtue of the FDCA disclosure requirements’”) (citation and quotation marks omitted).

Our non-preemption Estes post praised a discovery ruling that refused to require production of documents about other devices that the defendant made that were never prescribed for, or used by, the plaintiff.  The Fifth Circuit affirmed that as well:

[Plaintiff] also sought all consumer complaints for any [a different] device. . . . To the extent this discovery would even matter with the dismissal of the fraudulent concealment claim that we have just affirmed, we conclude that the trial court did not abuse its discretion in denying the discovery request.

Id.

Two days later, Elliott v. Sandoz, Inc., 2016 WL 4398407 (N.D. Ala. Aug. 18, 2016), completed the week’s Buckman Trifecta.  Elliott involved a generic drug, so the plaintiff’s immediate problem was to gin up some sort of claim that stood a prayer of getting around Mensing/Bartlett preemption.  This particular drug was approved only as a “last resort” for patients suffering from a life-threatening condition.  However, since the physician prescribed it off-label for a non-life-threatening condition, plaintiff made off-label promotion allegations against the both the defendant and the manufacturer of the branded reference drug (not a defendant).  2016 WL 4398407, at *2.

Plaintiff also alleged that the defendant (indeed, any seller of this drug) had to supply pharmacies with FDA-mandated “Medication Guidelines,” which were in turn supposed to be given directly to patients by pharmacies.  Id.  Plaintiff claimed that the defendant didn’t supply enough of these guides, the decedent (this was a wrongful death case) never received it, and wouldn’t have taken the drug if he had, because of the off-label use issue – that is, that the decedent would not have followed his doctor’s prescription.  Id.

These allegations in Elliott formed the basis for warning and fraudulent marketing claims.  Also included throughout the complaint were vague allegations that the defendant failed to warn “physicians” generally about the risks of off-label use.  No go.  Buckman, combined with TwIqbal, did them in.

First, Buckman.  Plaintiff was trying for the hypothetical “parallel claim” exception to generic drug preemption, alluded to in Bartlett, footnote 4 (we discussed that in more detail here).  Plaintiff argued that the medication-guide-based claims were “parallel” claims – alleging conduct violative both of state and federal law − and thus were not preempted.

Fail!

In her attempt to run away from Mensing/Bartlett, plaintiff ran headlong into Buckman.

The court finds the argument in favor of preemption is persuasive.  Plaintiff seeks to sue Defendant for an alleged violation of federal law and regulations − that is, Defendant’s failure to provide the Medication Guide.  The duty of Defendant to provide Medication Guides to pharmacies . . . arises solely under federal law.  See 21 C.F.R. §208.24(b).  Even if Mensing and its progeny do not apply in this case (which is doubtful because Plaintiff is ultimately arguing a “failure to communicate” theory . . .), Plaintiff’s claim that Defendant was negligent for failing to provide Medication Guides to Decedent is preempted by section 337(a).

2016 WL 4398407, at *6 (other citations and quotations omitted). Section 337(a), of course, is the foundation of Buckman preemption.  “The Supreme Court has held that ‘that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.”  Id. at *5 (quoting Buckman, 531 U.S. at 349 n.4 (which, in turn, cites §337(a)).

Nor could plaintiff point to any analogous state-law duty.  A medication guide goes to the plaintiff-patient.  The learned intermediary rule (adopted in Alabama, like everywhere else) bars warning claims based on direct-to-patient allegations. Id. at *6-7 (“the manufacturer has no further duty to warn the patient directly”) (citation and quotation marks omitted) (emphasis original). TwIqbal then nailed plaintiff’s “conclusory statement” that the defendant failed to warn “physicians.” Id. at *7.

Nor did plaintiff’s warning claims plausibly allege causation.  Employing judicial notice, the court observed that multiple companies manufactured this generic drug, id., and the prescribing physician could have relied on any (or indeed, none) of their warnings.  Id. (“any one of the [manufacturers] may (or may not) have influenced or warned [the prescriber] (adequately or inadequately) concerning off-label use of [the drug]”).  Finally, since plaintiff couldn’t plead enough to satisfy TwIqbal, she certainly couldn’t plead fraud-based claims with the specificity needed to satisfy Fed. R. Civ. P. 9(b). Id. at *8 (allegations were “quintessential examples of the ‘naked assertion[s] devoid of further enhancement’”) (citation omitted).

That makes three nifty Buckman-based wins – two of them appellate – in one week.  Keep up the good work.

It’s been two years since the First District California Court of Appeals issued its ill-founded decision in Bristol-Myers Squibb Co. v. Superior Court, 175 Cal. Rptr. 3d 412 (Cal. App. 2014), which used specific personal jurisdiction to accomplish what the United States Supreme Court had, only six months earlier, condemned as “grasping” and “exorbitant” when attempted through general personal jurisdiction in Daimler AG v. Bauman, 134 S. Ct. 746 (2014).  We immediately blogged about that decision in our “Hotel California” post – describing the California court’s rationale in considerable detail.

Fortunately, the California Supreme Court promptly granted an appeal, which we duly noted here, of the following two questions: “(1) whether after Daimler AG v. Bauman, 571 U.S. ––––, 134 S.Ct. 746, 187 L.Ed.2d 624 (2014), general jurisdiction exists; and (2) whether specific jurisdiction exists.” Bristol-Myers Squibb Co. v. S.C., 337 P.3d 1158 (Cal. 2014).

Thereafter “prompt” dropped out of the lexicon.

But today the wait is over.  The California high court has answered the two questions “no” and “yes.”  This latter ruling – a 4-3 decision − is almost certain to be appealed to the United States Supreme Court, as it creates a form of “specific” jurisdiction in mass tort cases that is every bit as “grasping” and “exorbitant” as that rejected as a Due Process violation in Bauman.  See Bristol-Myers Squibb Co. v. Superior Court (Anderson), S221038, slip op. (Cal. Aug. 29, 2016) (hereafter Anderson). Anderson involved mass tort litigation in California against a defendant that was neither headquartered nor incorporated in California, nor had any peculiar ties to the state.  The plaintiffs in question were also nonresidents of California, so the jurisdictional questions boiled down to whether California can constitutionally provide a forum for non-resident plaintiffs to sue a non-resident defendants.

This is quite apart from the practical question of why, given the severe funding crisis everyone recognizes as facing the California judiciary, California taxpayers should be burdened by thousands (or more) of suits by non-residents against non-residents.

Bauman, of course, rejected general jurisdiction theories that would expose corporations to suit in any state about anything.  As to Bristol-Myers-Squibb, a large pharmaceutical company that markets its products in all fifty states, the court unanimously agreed that general jurisdiction could not lie under Bauman.

Although the company‘s ongoing activities in California are substantial, they fall far short of establishing that is it at home in this state for purposes of general jurisdiction. . . .  In assessing [defendant’s] California business activities in comparison to the company‘s business operations “in their entirety, nationwide,” we find nothing to warrant a conclusion that [it] is at home in California.  As the high court warned in [Bauman], to conclude that [defendant] may be sued in California on any cause of action, whether or not related to its activities here, under a theory of general jurisdiction, would be to extend globally the adjudicatory reach of every state in which the company has significant business operations.

Slip op. at 14 (citations omitted).  In Bauman, “the high court plainly rejected the theory that a corporation is at home wherever its sales are ‘sizeable.’”  Id.  Merely being a large corporation selling products and having business operations in every state – including dealings with Calfornia distributors − isn’t enough.  Id. at 14-16.  Nothing on the order of the “exceptional fact pattern” in Perkins v. Benguet Mining Co., 342 U.S. 437 (1952) (Philippine corporation moved its entire business to Ohio due to wartime occupation), is present in the interstate operations of a large pharmaceutical company.  Slip op. at 15.

Anderson also rejected general jurisdiction based on “consent” – by virtue of the defendant’s having registered to do business and maintained an agent for service of process in California.

California law, however, requires a foreign corporation transacting business here to name an agent in the state for service of process. . . . [T]he purpose of state statutes requiring the appointment by foreign corporations of agents upon whom process may be served is primarily to subject them to the jurisdiction of local courts in controversies growing out of transactions within the State.  Accordingly, a corporation’s appointment of an agent for service of process, when required by state law, cannot compel its surrender to general jurisdiction for disputes unrelated to its California transactions.  The designation of an agent for service of process and qualification to do business in California alone are insufficient to permit general jurisdiction.

Id. at 15 (citation and quotation marks omitted) (emphasis added).

Specific personal jurisdiction, however, is based on a “minimum contacts” analysis that precludes only assertion of jurisdiction that would violate “traditional notions of fair play and substantial justice.” Slip op. at 5 (quoting International Shoe Co. v. Washington, 326 U.S. 310, 316 (1945).  This requires that the litigation “arise out of or are connected with the [company‘s] activities within the state.”  Id. at 6 (same).  This Due Process language was pliable enough to allow the same thing – “jurisdiction for disputes unrelated to its California transactions” – for any mass tort.  All plaintiffs have to do is simultaneously have California residents make the same allegations.

California uses a multi-factor test (Anderson calls it a “sliding scale,” id. at 26) for “relatedness” for evaluating specific jurisdiction as “fair” or not:

This test requires courts to evaluate the nature of the defendant‘s activities in the forum and the relationship of the claim to those activities in order to answer the ultimate question under the due process clause: whether the exercise of jurisdiction in the forum is fair.  Under the substantial connection test, the intensity of forum contacts and the connection of the claim to those contacts are inversely related.  The more wide ranging the defendant‘s forum contacts, the more readily is shown a connection between the forum contacts and the claim.

Slip op. at 19 (citation and quotation marks omitted).  Critically enough to be quoted three times, in California “[a] claim need not arise directly from the defendant‘s forum contacts in order to be sufficiently related to the contact to warrant the exercise of specific jurisdiction.”  Id. at 19, 20, 22 (identical quotations).

First, the court had find “purposeful availment.”  For that jurisdictional requirement, it was enough that the defendant corporation advertised and sold its products in California – even if the plaintiffs in question were out-of-state litigation tourists.  Id. at 20.

For relatedness, the more difficult proposition, the court relied primarily upon prior precedent involving a California third-party plaintiff (Von’s grocery stores, in a third-party action) suing out-of-state defendants.  Id. at 20-22 (discussing Vons Companies, Inc. v. Seabest Foods, Inc., 926 P.2d 1085 (Cal. 1996)).  That the majority in Anderson could not find any precedent at all involving non-resident plaintiffs demonstrates how great a stretch its expansion of specific jurisdiction really is.  According to Anderson’s gloss on Vons, any “substantial connection” between the defendant’s activities and the forum, even if totally non-causal of the specific plaintiff’s injuries, is enough – even for a non-resident plaintiff – as long as a resident plaintiff has brought a similar suit.  Here’s the money quote:

Both the resident and nonresident plaintiffs‘ claims are based on the same allegedly defective product and the assertedly misleading marketing and promotion of that product, which allegedly caused injuries in and outside the state. Thus, the nonresident plaintiffs’ claims bear a substantial connection to [defendant’s] contacts in California.  [Defendant’s] nationwide marketing, promotion, and distribution of [the drug] created a substantial nexus between the nonresident plaintiffs’ claims and the company’s contacts in California concerning [that drug].

Slip op. at 23.  Anderson reached the same attenuated jurisdictional conclusion with respect to other claims that targeted the drug’s development and design.  Id. at 24 (“that the company engages in research and product development in these California facilities is related to plaintiffs’ claims . . . that even if those claims do not arise out of [defendant’s] research conduct in this state”).

Thus, the California Supreme Court has, for mass torts at least, created the same universal sort jurisdiction that Bauman condemned as “grasping” and “exorbitant” in the context of general jurisdiction – only it calls it “specific jurisdiction.”  Under this logic, any plaintiff could sue this defendant (or any other large company) in any state of the union, as long as some in-state plaintiff is making the same claim.  This result is broader even than the discredited concept of pendent jurisdiction, through which other plaintiffs failed to obtain the same result.

Indeed, the majority essentially concedes this point, calling it an “invalid assumption” that a defendant’s “forum contacts must bear some substantive legal relevance to the nonresident plaintiffs‘ claims.”  Slip op. at 25 (once again relying solely on Vons, which involved only a resident plaintiff).  Any “forum contacts” that “are part of the nationwide marketing and distribution of [a product]” are ipso facto “substantially connected to the nonresident plaintiffs‘ claims” also involving that product.  Id.  Under this rationale, any “nationwide marketer” of a product may be sued by anyone in any state, as long as some in-state plaintiff also makes the same allegations.  See Id. at 31 (arguing that given 86 California plaintiffs, addition of another 592 litigation tourists is less of a “burden” than litigating where those other plaintiffs reside); at 32 (“other injuries” anywhere in the country, can be evidence of defect).

Finally, Anderson seems to be creating a special – and particularly pro-plaintiff – jurisdictional rule specifically for mass torts:

[B]ecause mass tort injuries may involve diverse injuries or harm not amenable to the efficiency and economy of a class action, they present special problems for the proper functioning of the courts and the fair, efficient, and speedy administration of justice. Without coordination, those who win the race to the courthouse and bankrupt a defendant early in the litigation process would recover but effectively shut out other potential plaintiffs from any recovery. Moreover, coordinated mass tort actions also avoid the possible unfairness of punishing a defendant over and over again for the same tortious conduct.

Slip op. at 35 (citations and quotation marks omitted).  Anderson cites no jurisdictional cases for this totally unprecedented result (not even Vons).  Nothing in United States Supreme Court precedent supports the contention that mass tort defendants are entitled to less Due Process consideration than other defendants in other sorts of litigation.

Thus, the result in Anderson is indistinguishable from the jurisdictional result condemned in Bauman.  The supposed “sliding scale,” id. at 26, in Vons has become a slippery slope, and in Anderson California has slid all the way to the bottom.  The extensive, three justice dissent recognized that the majority’s result is untenable and contrary to modern Due Process principles:

[M]inimizing the relatedness requirement undermines an essential distinction between specific and general jurisdiction. In [Bauman], the United States Supreme Court made clear that general jurisdiction − jurisdiction to adjudicate controversies unrelated to the defendant’s forum contacts − is not created merely by commercial contacts that are “continuous and systematic, but only by contacts so extensive as to render the defendant “at home” in the forum state. . . .  But by reducing relatedness to mere similarity and joinder, the majority expands specific jurisdiction to the point that, for a large category of defendants, it becomes indistinguishable from general jurisdiction.  At least for consumer companies operating nationwide, with substantial sales in California, the majority creates the equivalent of general jurisdiction in California courts.  What the federal high court wrought in [Bauman] − a shift in the general jurisdiction standard from the “continuous and systematic” test . . . to a much tighter “at home” limit − this court undoes today under the rubric of specific jurisdiction.

Anderson, dissenting slip op. at 4-5 (citations and quotation marks omitted) (emphasis added).

California has no discernible sovereign interest in providing an Ohio or South Carolina resident a forum in which to seek redress for injuries in those states caused by conduct occurring outside California.  A mere resemblance between the nonresident plaintiffs’ claims and those of California residents creates no sovereign interest in litigating those claims in a forum to which they have no substantial connection.

Id. at 11. See also Id. at 17-18 (pointing out that Vons involved a California third-party plaintiff seeking indemnity for the defendants’ “California activities”).

There’s lots else in the dissent (interest analysis, interstate comity, and analysis of lots of cases, to name three), which we commend to any interested readers, but for our purposes, it’s time to refocus on the United States Supreme Court, where Anderson in undoubtedly headed.  We think that the Supreme Court – in its rejection of “grasping” and “exorbitant” theories of personal jurisdiction – would be interested in what the dissent has to say:

Such an aggressive assertion of personal jurisdiction is inconsistent with the limits set by due process.  Although those limits are more flexible and less strictly territorial than in the past, the high court has explained that they still act to keep any one state from encroaching on the others. . . .  That [defendant] marketed and sold [a product] throughout the United States, presumably using much of the same advertising in many markets, does not give California authority, under our federal system, to assert jurisdiction over claims arising throughout the nation.

Id. at 33-34 (citation and quotation marks omitted) (emphasis added).

At this point, we can only say “take it up,” and hope that the Supreme Court will once again be willing to review a blatant attempt to nullify its recent precedent.

We’ve always been bothered by the presumption against preemption – so much that this blog’s first major substantive post was on that subject.  Even before that, back in the Bone Screw days, we remember the presumption against preemption accompanying the death of express preemption for 510(k) medical devices in Lohr.  In Lohr, the presumption was used as a narrowing principle of statutory construction: “[W]e use[] a presumption against the pre-emption of state police power regulations to support a narrow interpretation of such an express command.”  Id. at 485.  Then along came Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), which (as we pointed out at the time) upheld preemption of pre-market approved medical devices under the same statutory provision with nary a peep about any preemption-busting presumption.  Nonetheless, even after Riegel, some lousy circuit court decisions still invoked the presumption as a way of poking holes in PMA preemption, most notoriously the en banc Ninth Circuit in Stengel v. Medtronic Inc., 704 F.3d 1224, 1227-28 (9th Cir. 2013), which fawned over the presumption at some length before deciding that a duty to provide information to a governmental agency wasn’t any different than a bog standard product liability duty to warn.

The presumption also came up in the context of the Vaccine Act, where one court (discussed here) sought to nullify statutory preemption by latching onto a statement in Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005) (a non-FDCA case), about there being “a duty to accept the reading [of a statute] that disfavors pre-emption,” even where there are other equally “plausible” interpretations. Id. at 449.  That view was shot down by the Supreme Court in Bruesewitz v. Wyeth LLC, 562 U.S. 223 (2011), which interpreted the Vaccine Act’s preemption clause in a pro-preemption direction with nary a mention of the erstwhile adverse presumption – something else we mentioned at the time.

Then along came PLIVA v. Mensing, 564 U.S. 604 (2011), where four justices found, if anything, a presumption in favor of presumption, id. at 621-23 (viewing the Supremacy Clause as a constitutional “non obstante” provision), four justices disagreed, and one didn’t take a position.  Mensing, of course, was an implied preemption case.

For these reasons, we speculated a little over a year ago whether the presumption against preemption might be dead.  Then a little later, we thought we might be wrong.

Turns out we’re half right.

In a case decided this June, the Supreme Court appears to have killed the presumption against preemption in express preemption cases – that is with respect to express preemption clauses of the sort at issue in Lohr and Bruesewitz.  The Court did so in Puerto Rico v. Franklin-California Tax-Free Trust, 136 S. Ct. 1938 (2016).  We missed it at the time because the substantive issue was bankruptcy, which is far afield from our rather limited sandbox.  The preemption issue was whether Puerto Rico was a “state” within the meaning of the express preemption clause (11 U.S.C. §903(1)) of Chapter 9 of federal bankruptcy statute.

We’ll spare you the details and cut directly to what the Court held about the presumption against preemption. The sides offered conflicting interpretations of whether Puerto Rico was still a “state” for purposes of the preemption clause – if it was it couldn’t pass its own municipal bankruptcy statutes deviating from federal law, if it wasn’t, the local statute escaped preemption.  PR v. Franklin, 136 S. Ct. at 1946.  The Court concluded that “Respondents [entities disadvantaged by the local statute] have the better reading.  We hold that Puerto Rico is still a ‘State’ for purposes of the pre-emption provision.” Id.

Puerto Rico opposed this result by relying on the presumption against preemption – that the presumption required reading the preemption clause narrowly. The Court disagreed, holding that there was no presumption at all where a court was applying an express preemption clause:

The plain text of the [preemption clause] begins and ends our analysis. Resolving whether Puerto Rico is a “State” for purposes of the pre-emption provision begins “with the language of the statute itself,” and that “is also where the inquiry should end,” for “the statute’s language is plain.”  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.

Id. (emphasis added).  RIP presumption against preemption in express preemption clauses – “we do not invoke any presumption against preemption.”

PR v. Franklin is a 5-2 majority opinion.  Justice Thomas – the scourge of the presumption against preemption in Mensing – wrote it, and was joined by Chief Justice Roberts, Justice Kennedy (who created a 4-4 split in Mensing by joining neither side), Justice Breyer, and Justice Kagan.  Another Mensing foe of the presumption against preemption, Justice Alito, did not participate.  The bolded language above quotes from United States v. Whiting, 563 U.S. 582, 594 (2011), a decision that we observed in a prior preemption post was a plurality “split in more ways than are worth describing.” Whiting, which preempted most of Arizona’s 2007 Trumpist precursor immigration restriction, simply stated that “[w]hen a federal law contains an express preemption clause, we ‘focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ preemptive intent.’”  563 U.S. at 594 (quoting CSX Transportation, Inc. v. Easterwood, 507 U.S. 658, 664 (1993)).

Obviously, the plurality in Whiting didn’t say anything about the presumption against preemption in that quote – that was added, entirely and intentionally, by the majority in PR v. Franklin.  Equally obviously, by splicing in the language “we do not invoke any presumption against preemption,” the majority knew exactly what it was doing – killing the presumption in express preemption cases.

Nor is it just us who thinks that. We found out about PR v. Franklin last week when we read In re Syngenta Ag Mir 162 Corn Litigation, 2016 WL 4382772 (D. Kan. Aug. 17, 2016), a food case interpreting the preemption clause (7 U.S.C. §87g(a)) of something called the Grain Standards Act.  That case involved the type of federal preemption of common-law tort claims that we deal with all the time, which is why we were reading it.  Not unexpectedly, the plaintiffs trotted out the presumption against preemption to oppose the defendants’ preemption arguments.  To no avail:

[P]laintiffs argue that the Court should apply a presumption against preemption. The parties acknowledge that the Supreme Court has appeared to take inconsistent positions with regard to whether such a presumption applies in the case of an express preemption provision.  The Supreme Court ruled on the issue fairly definitively in recent months, however, concluding in one case that “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.”  Thus, this Court will not invoke any presumption in applying the [statutory] express preemption provision.

2016 WL 4382772, at *3 (quoting PR v. Franklin, as previously quoted above).

The 2016 demise of the presumption against preemption in express preemption cases will affect the application of preemption for every federally regulated product where the organic statute has a preemption clause. Of particular importance to us and our clients, PR v. Franklin should eliminate the presumption against preemption in all cases involving medical devices, meaning that, in this respect, Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), can no longer be considered good law.

The Ninth Circuit filed a preemption opinion the other day that should help prevent the “foodification” of medical device litigation. That made-up word refers to the wasteful food-related class action litigation that has somewhat thrived in California.  The template is familiar:  Opportunistic plaintiffs’ lawyers find some aspect of food labeling that they claim is misleading—e.g., that a product is “wholesome” or “natural”—and they recruit a plaintiff to say that he or she would not have purchased the food or would have paid less for it had truth been told.  We wrote more than two years ago about a class action claiming that Hershey chocolates made misleading “healthy diet claims.”  Who would possibly rely on “healthy diet claims” for chocolate treats?  That class action obviously had no legs, but others have gotten by.

Attempts to extend this business model to medical devices have failed, and one reason is federal preemption. That is our takeaway from DeBons v. Globus Medical, Inc., No. 14-5645, 2016 WL 4363171 (9th Cir. Aug. 16, 2016), where the Ninth Circuit affirmed the district court’s order dismissing a putative class action involving bone putty, an allograft tissue product that the FDA regulates as a medical device. See the district court’s dismissal order, DeBons v. Globus Medical, Inc., No. 2:13-cv-08518, 2014 WL 12495351 (C.D. Cal. Aug. 8, 2014).  Taking a page from the food playbook, the plaintiff claimed that the device was “not in fact FDA approved,” which we take to mean that product was “cleared” through the 510k process rather than formally “approved.”  He alleged therefore that “had made it known that the product was not FDA approved,” he would not have paid for it. Id. at *1.  He asserted a raft of consumer fraud claims, including a claim under California’s broadly written Unfair Competition Law, and purported to represent a class of other bone putty patients. Id. Bear in mind that the plaintiff alleged no surgical complication; the device evidently worked just fine.  This was strictly a play for a price refund.

Here is where it gets interesting. The main reason why medical device class actions are so rare these days is that medical treatment unavoidably presents individualized issues, making class treatment impossible.  Another reason is Section 337(a) of the FDCA, which gives the FDA exclusive authority to enforce the Act’s provisions.  This provision impliedly preempts any private action right of action filed because a device manufacturer’s conduct allegedly violates the FDCA. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001).  When combined with the Medical Device Amendments’ express preemption provision, would-be plaintiffs face the “narrow gap” between implied preemption and express preemption on which we often comment (such as here). On the one hand, the MDA’s express preemption provision bars states from enforcing requirements “different from or in addition to” federal requirements.  21 U.S.C. § 360k(a).  On the other hand, private litigants cannot enforce the FDCA.  A plaintiff therefore “must be suing for conduct that violates the FDCA (or else his claim is expressly preempted . . . ), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman).” DeBons, 2016 WL 43463171, at *1 (quoting Perez v. Nidek Co., Ltd., 711 F.3d 1109, 1120 (9th Cir. 2013)).

Food law is a little different. Section 337(a) should create implied preemption in food cases too, for example in cases claiming that food labeling is misleading.  After all, the FDA regulates food labeling in great detail, and federal law should preempt any private right of action to enforce those requirements.  But the FDCA’s express preemption provision for food is slightly different from the Medical Device Amendment’s express preemption provision.  It prohibits states from imposing requirements that are not “identical” to an applicable food labeling standard [21 U.S.C. § 343-1(a)], which has been construed as an exception to the FDA’s prosecutorial exclusivity.  An example is the California Supreme Court’s opinion in In re Farm Raised Salmon, 175 P.3d 1170 (Cal. 2008) (which we wrote about here), where the Court held that Section 343-1 authorized states to enact food labeling laws “identical to” federal law and also permit the private enforcement of those laws.  Although we disagree with its reasoning, the California Supreme Court concluded that the legislature had done just that, thus avoiding implied preemption of claims alleging that salmon labeling was misleading. Id. at 1178-79.

There is no such “exception” to preemption for medical devices. On this point, the district court’s order dismissing DeBons v. Globus and the Ninth Circuit opinion affirming the dismissal properly resisted the plaintiff’s invitation to “foodify” medical device litigation.  As in food cases, the plaintiff tried to evade implied preemption by invoking California’s consumer laws and arguing that some of his claims “would exist independent of the FDCA” as a matter of state law.  2014 WL 12495351, at *3.  But the district court saw through that argument and concluded that “fundamentally, these claims are still premised entirely on the FDCA.” Id. The plaintiff therefore could not avoid preemption by placing a “state law” label on claims that were “fundamentally” meant to enforce the FDCA.  As the district court stated:

If Plaintiff’s argument was accepted, the doctrine of implied preemption under 21 U.S.C. § 337(a) and Buckman would be almost entirely eliminated and private citizens would in effect be permitted to enforce the FDCA’s requirements.  Such a reading is at odds with § 337, which provides that all proceedings to enforce the FDCA “shall be by and in the name of the United States.”

Id. at *4. It is difficult to argue with this reasoning.  Moreover, the Ninth Circuit agreed and affirmed the dismissal, with only one exception:  The plaintiff alleged a breach of contract based on an alleged “contractual representation” by the company that the product was “FDA approved” or had been determined to be “safe and effective.”  2016 WL 4363171, at *1.  Because such a contract would be a self-imposed undertaking, and not a state-imposed obligation, federal law would not preempt a breach of contract claim. Id. The plaintiff, however, could not identify any facts supporting a contract, despite four opportunities to amend his complaint.  The Ninth Circuit therefore affirmed the dismissal of the contact claim too, but on different grounds.   Id.

This is a welcome result, and we regret only that the Ninth Circuit opinion is unpublished.  If courts are going to allow food class actions, it is worthwhile to understand that medical devices operate in a different universe, where courts ought to hold the line.

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

 

We’ve been posting for a few months about the procedural and evidentiary controversies that have arisen in the Pinnacle Hip Implant MDL bellwether process. The second bellwether trial involved significant evidentiary and procedural rulings that raised eyebrows across the defense bar (discussed here and here). After that trial unsurprisingly produced a ½ billion dollar jury verdict, the defense asked the MDL Court to stay further bellwether trials so that the Fifth Circuit could review those rulings. No luck. Instead, the MDL Court ordered that the next bellwether trial should happen—and quickly (discussed here). After all that, and with the third bellwether trial approaching fast, the defense must feel like the coyote lying flat on the ground staring up at the bottom of a plummeting anvil coming at him a second time.

Undaunted, however, the defense has now filed a motion to continue the third bellwether trial, a motion that raises serious concerns about the time allotted to “work-up” the plaintiffs’ cases that will be involved in the trial. The defense argues that the allotted time is simply too short, not providing enough time for the complex medical issues underlying each plaintiff’s case to be developed and understood so that a trial can produce the type of verdicts that can advance the MDL process. To illustrate this, the defense compared the discovery and pre-trial periods that led up to the second bellwether trial (Aoki) to those leading up to this trial:

  • In Aoki, there were 11 months between case selection and trial (2/27/2015-1/11/2016); here, by contrast, there are just 3 ½ months between case selection and trial (6/10/2016-9/26/2016).
  • In Aoki, there were more than seven months between case selection and the due dates for defendants’ expert reports (2/27/2015-10/9/2015); here, by contrast, there are just 2 ½ months between case selection and the due date for defendants’ expert reports (6/10/2016-8/26/2016).
  • The Aoki schedule afforded defendants eight weeks to respond to plaintiffs’ expert reports (8/14/2015-10/9/2015); here, by contrast, defendants are being given just two weeks to analyze and respond to plaintiffs’ expert reports.

(Defense Br. at 9.)

This truncated schedule, the defense argues, is inadequate to gather medical records, prepare defense expert reports, or effectively brief and decide dispositive legal issues. For example, the defense still doesn’t have important medical records for three of the bellwether cases. The defense also just recently received about 2,400 pages of medical records in a fourth bellwether case. Yet the defense must serve expert reports in a few days, and trial starts in less than four weeks. The defense must also serve all of its expert reports before it has had the opportunity to depose seven of the eight treating surgeons whose depositions it has requested. You don’t need to be a veteran of medical device mass tort trials to know how important medical records, treating physician testimony and expert opinions are at trial. Jury verdicts often turn on just this type of evidence. Moreover, the court scheduled Daubert and other potentially dispositive motions to be filed on the same day it begins picking a jury. Without addressing whether that schedule already signals that the court intends to go forward with the trial, it certainly doesn’t seem to give the court enough time to give these motions the type of pre-trial consideration that they require. We have seen many a bellwether trial stopped—and rightfully so—by a Daubert motion that highlighted a lack of scientific merit in the plaintiff’s case.

Plaintiffs have responded by arguing that the defense already has enough medical records, that its experts should be able to draft and serve case-specific expert reports very quickly, and that the Court has issued Daubert decisions in the past—which plaintiffs no doubt liked—and so the Court can easily decide the new motions quickly. In other words, full speed ahead.

Given how things have gone so far in this MDL, we don’t expect the court to grant the defense’s request for a continuance. But, with each such decision, the list of evidentiary, procedural and now case-management issues for the Fifth Circuit to consider grows. This all may result in a very interesting Fifth Circuit opinion addressing the things to do, and not to do, when managing a mass tort.  And so, of course, we will continue to follow . . . .

You wouldn’t be the first to notice that some of our posts say more about television programs – and certainly with more gusto – than about the law.  We could make the case that pop culture and the law are related, and that familiarity with the former can make one a better advocate when engaged in the latter.  We could even cite an article on the value of pop culture that was written by an in-house lawyer who might be the smartest person we know.  But let’s not perpetrate a fraud.  Truth be told, it’s flat-out easier to tackle tv than preemption.  Would you rather binge watch Orange is the New Black or the latest judicial jibberings on the parallel violation exception?  Especially in these lingering dog days of Summer, not much in the law seems dramatic or even mildly entertaining.  To be sure, not so long ago the Summer was also a wasteland for television.  The good stuff concluded in the Spring.  Summer was strictly for repeats.  Under the old model, after fine offerings such as Game of Thrones and The Americans wrapped up before Memorial Day, there would be nothing worth watching until the Fall season, when a couple of decent shows might temporarily distract you from the decline of the West (by which we mean the American League West, the AFC West, and the overall culture of the Enlightenment).  But things have changed when it comes to programming.  Television comes through whilst the law remains in its mid-year torpor.  Of a sudden, Summer tv offers a bounty for couch potatoes seeking an escape from the inferno.  So hang up that seersucker suit, pour out a Pimm’s, and feast your eyes on these tv treasures:   

 

Stranger Things (Netflix) – We love the 80s.  That was when we entered law school and, more importantly, exited law school.  A decade that starts with the eruption of Mt. St. Helens and ends with the collapse of the Berlin Wall, and that introduced Seinfeld and The Simpsons in-between, is special.  Stranger Things is a love letter to the 80s.  It is a Spielbergian, Stephen King-ian mash up of horror, sci-fi, government conspiracy, and teen-agers coming of age. Stranger Things also supplies a great role for Winona Ryder, who first grabbed our eyes in Heathers (1988). You know how at the end of a Netflix episode a clock starts counting down in the corner, and you have to decide either to exit or let the next episode start?  With Stranger Things, we always let the next episode take over the screen, and let all the next episodes take over our day.  Could.  Not.  Stop.  Watching.     

 

Mr. Robot (USA) – Maybe this bold show is undergoing something of a sophomore slump, but the episode that mimics 90s sitcoms (e.g., Full House, Family Matters) may have been the best hour of tv since Cersei burned down the town and the Khalisi set sail with a dragon escort.  If you watch this show, you might actually have something substantive to say to the techno-geeks who patrol your office.  And they might have something to say to you besides, “Have you tried rebooting?”  

 

The Night Of (HBO) – One always has high expectations for any show in the 9 pm Sunday night slot on HBO, and The Night Of does not disappoint. It is based on a British show called Criminal Justice.  One of the writers for the American version is Richard Price, who has penned some fine novels (Lush Life) and some of the best episodes of The Wire.  The first couple chapters of The Night Of were blisteringly suspenseful, reminding us how modern technology spies on us, but how there are still tragedies that manage to evade the cameras and our understanding.  Then the show settled into a Law & Order-type procedural, complete with the requisite interview of someone at their workplace.  (Comedian John Mulaney does a bit about a guy calmly loading crates onto a truck while answering questions about a grisly murder.  “Tony Ramirez?  Yeah, I remember him.  Worked on Tuesdays, I think.”  Keeps lifting crates.  A detective puts a picture under the witness’s nose.  The witness hardly pauses as he flings a crate into the trailer.  “No, I don’t recognize him”  Picks up another crate.)   The workplace interview in The Night Of involved a hearse driver, so the creepiness level was turned up to 11.  The most recent entry of The Night Of featured a cross-examination of a defense expert by the prosecutor.   The expert and prosecutor clearly have been locking horns for many years.  By now, they know each other’s moves.  They even seem to enjoy each other’s company.  The wry back-and-forth reminded us of some mini-battles we have had with certain plaintiff experts we have deposed repeatedly.  Of course, in our case there was no murder — except, you know, for the expert’s occasional murder of the truth.

 

Watch these shows and you will thank us.

  

What’s that?  You came to this blog to learn a little something about the law, not television?  Okay, if you insist.  But how about if we split the difference, and discuss a case about television?  To be precise, it is a case about televisions, in the plural.  In Oliver v. Funai Corp., 2015 WL 930541 (D. N.J. Dec. 21, 2015), the plaintiffs claimed that the defendants sold them defective televisions.  The defect consisted in certain allegedly faulty components.  When those components went bad, the televisions would  “stop displaying a picture and sound.”  That does, indeed, seem like a problem.  The plaintiffs alleged that the televisions in question typically failed outside of the stated one-year warranty period and ninety-day warranty period for labor, leaving consumers with little reprieve.  The legal claims included fraudulent concealment and the like.  There were two plaintiffs, one in Massachusetts and one in Arizona.  One of the plaintiffs alleged that he purchased his television in September of 2012, and that the same television failed in January 2014, after only 190 hours of usage.  At this point, and not just because we are a crotchety defense hack, we grew suspicious of that plaintiff.  Four months of tv viewing, totaling only 190 hours?  That’s just a little more than an hour and a half a day.  Who watches so little tv?    Most people would burn through 190 hours just during the NFL playoffs.  Was this person confining their viewing to PBS specials on How Turtles Do Calculus, or the Cleveland Symphony’s production of an opera based on Kafka’s Metamorphosis, “Roach!”  Surely there is an issue in this case of credibility and/or limitation of damages.   

 

What does any of this have to do with drug or device law?  The Oliver case involves one issue we have addressed a lot recently, personal jurisdiction, and one we hardly ever see, which is whether internet postings constitute information that can be attributed to a corporate defendant. 

 

Personal Jurisdiction

  

The defendants in Oliver were (1) Funai Corp., which is incorporated and has its principal place of business in New Jersey, and (2) its parent, Funai Electric, a company incorporated and headquartered in Japan.   Was there personal jurisdiction over the Japanese parent company?  As most of our readers know by now, personal jurisdiction consist of both general jurisdiction and specific jurisdiction.  With general jurisdiction, a company can be sued for anything.  With specific jurisdiction, a company can be sued only for its conduct specifically in and targeted to that particular jurisdiction.  Under the Supreme Court’s decision in Bauman, general jurisdiction extends only to companies that are essentially “at home” in that jurisdiction, and that at-home-ness applies to place of incorporation, principal place of business, and extremely rare exceptions, such as temporary relocation of a company during war time.  The Oliver court easily decided that the plaintiffs could not show general jurisdiction under the paradigmatic examples laid out in Bauman.  In support of their general jurisdiction argument, the plaintiffs chiefly relied upon the fact that Funai Electric allegedly “funnels its televisions through the State of New Jersey.”  But it is well-settled by the Supreme Court that while “[f]low of a manufacturer’s products into a forum … may bolster an affiliation germane to specific jurisdiction… ties serving to bolster the exercise of specific jurisdiction do not warrant a determination that, based on those ties, the forum has general jurisdiction over a defendant.” 

 

So now we are onto specific jurisdiction.  And the plaintiffs still do not have enough contacts to cross the finish line.  The Oliver court concluded that the connection between Funai Electric’s allegedly manufacturing televisions for distribution to its New Jersey subsidiary was not enough to establish jurisdiction in New Jersey for a case where the plaintiffs bought, used (though clearly not enough), and were unhappy with their televisions in other states.  In fact, the plaintiffs’ argument for specific jurisdiction was really another general jurisdiction argument in disguise.  Under their theory, by running televisions through a New Jersey distributor, a company at home in Japan would have opened itself up to litigation in New Jersey by any American consumer.  The court rejected such a nonsensical result.  Indeed, the court was so struck by the nonsensical nature of the plaintiffs’ position that it also rejected a request for jurisdictional discovery.   

 

Fraudulent Concealment

 

With Funai Electric now out of the Oliver case, that left only Funai Corp., which also had a strong argument for dismissal on the pleadings.  Funai Corp contended that the plaintiffs could not meet the elements of a fraudulent concealment claim because the plaintiffs failed to plead that Funai Corp. knew of the defect prior to the plaintiffs’ purchases.  In response, the plaintiffs directed the court to “numerous consumer complaints that ‘date back to 2011 and beyond.” But the complaints appeared on the websites of third-parties such as Amazon and Wal-Mart, and the plaintiffs provided no indication that the defendants viewed or would have viewed those websites.  Moreover, many of the postings, written by unknown bloggers (i.e., “oliveubabe” and “2ofakind0”) [Sure, those are funny names.  But have you seen some of the names our commenters use?  Which reminds us — “Cocaine Princess,” where have you been?], did not specifically reference the defect alleged in the plaintiffs’ complaint; rather, they alleged general problems with the televisions’ functionality or quality.  Accordingly, the court was not persuaded that knowledge of the alleged defect could be imputed to the defendants based upon anonymous internet complaints on third-party websites.  Nor was the court persuaded that knowledge could be imputed to the defendants based upon the representations made in the anonymous internet complaints that the consumers contacted the defendant via phone to voice their concerns.    

 

This ruling in Oliver should be of interest to our clients.  As the court reasoned in Oliver, “[i]mputing knowledge of a defect to a manufacturer based upon an internet posting would mean that virtually every consumer product company would be subject to fraud claims and extensive discovery.”  That is true because everything is on the internet.  And by “everything,” we mean everything that is true, false, something-in-between, and crazy.  If the mere existence of some statement or accusation on the internet could be attributed to a corporate defendant, then it is open season for alleging all sorts of corporate frauds.   That is an unacceptable result.  The internet, as wonderful and useful as it can be, is a vast mess.  Most of what you see on the internet is ridiculous, frivolous, and merits no assumption of veracity. 

 

There is one exception.  If you are on our website and you are reading legal analysis or a tv recommendation, then you can take judicial notice.    

 

 

 

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

Everybody lies, maybe even several times a day. Often we don’t even realize it because the lies are small. They are white lies like “of course that shirt looks good on you.” What about all those times we nod while someone is talking but we really aren’t listening. Aren’t those lies too? Then there are those lies we tell ourselves, sometimes necessary to get through the day with our self-esteem intact.

But what about the biggies? The look someone in the face and make up something that is simply not true just to benefit oneself type of lie. The type of lie that is told when someone cheats or steals. Or, the type of lie that is told when a lawyer doesn’t do his or her homework but makes representations to the court as if they did. Look, nobody is perfect and there are times, especially in mass torts with lots of plaintiffs, where facts get jumbled or twisted a bit. Times when a little more digging before filing a lawsuit would have revealed different product usage or dates of ingestion. And sometimes those minor differences in facts can lead to cases being dismissed that probably shouldn’t have been brought in the first place. But complete fabrications of the core facts on which a case rests, in multiple cases – that’s going to get you sanctioned. And worse than a sanction, you’re going to lose your credibility with the court.

Losing credibility with the court isn’t something any lawyer ever wants to have happen. It also doesn’t take the extreme misrepresentations we are going to tell you about with today’s case. Promising things by certain dates and not delivering. Overstating a position and not being able to back it up. Being unprepared generally and repeatedly. All of this can lead to a court’s disfavor; to a judge doubting a lawyer’s veracity. While today’s case is very unique and the court’s distrust is directed to plaintiffs’ counsel, the most important to keep in mind is you don’t want to be in this position. Every time you address a court, in writing or in person, know your facts, know your law, and be honest.

That brings us to Johnson v. Smithkline Beecham Corp.2016 WL 4426164, slip op. (E.D. Pa. Aug. 10, 2016) in which fifty-two plaintiffs born in the late 1950’s or early 1960’s filed state-court Thalidomide suits in Philadelphia against GlaxoSmithKline and certain of its affiliates (“GSK”), along with Sanofi-Aventis and/or Grunenthal GmbH. The cases were removed to the United States District Court for the Eastern District of Pennsylvania on diversity grounds.

We posted about this case over a year ago when one of the plaintiff’s claims was dismissed on summary judgment. At that time we noted that in October 2015, twenty-eight plaintiffs had moved to dismiss their claims against GSK with prejudice (their claims against the other defendants would continue). Those dismissals are the subject of this month’s Report and Recommendation by the Special Discovery Master. The ultimate conclusion of the Special Master is that the dismissals should be allowed, the heart of the decision is about why the dismissals were questioned in the first place.

The problems with this group of cases goes back to the original complaints, which were verified, upon information and belief, by plaintiffs’ counsel.  Because plaintiffs were seeking to bring what amount to 50-year old claims, their complaints had to address how it was that they were unaware of their thalidomide-related injuries until approximately 2010. Johnson, slip op. at 8. At the motion to dismiss phase, the court had to accept these allegations as true. But discovery quickly showed that not to be the case. That’s when it was learned, for instance, that three plaintiffs, who in their complaint alleged they couldn’t have known about the defendants’ roles in their alleged injuries before 2010, had previously filed legal claims for these injuries and at least one was still collecting settlement checks. Id. at 10. Another plaintiff alleged in his complaint that he “was left with no understanding of what it meant to be a thalidomider.” Id. at 12. But at his deposition, that same plaintiff not only testified that in the 1960s his mother told him thalidomide had caused his injuries, but also that in 1983 he sought disability for his thalidomide-based injuries, in the 1990s plaintiff’s mother gave him the bottle of thalidomide pills she had taken, and in 2000 plaintiff gave an interview in which he stated that his injuries were caused by thalidomide. Id. at 12-13. These “major discrepancies” between the allegations and the facts are what led the court to refer to plaintiffs’ counsel as “unreliable bringers of truth.” Id. at 12. They also led to GSK filing multiple motions for sanctions against plaintiffs’ counsel, at least one of which plaintiffs’ counsel didn’t oppose. Id. at 13.

It was against that background that the court decide to have the Special Master conduct an investigation into the twenty-eight dismissals with prejudice.   The court was concerned that the “deal was suspiciously out of balance.” Id. at 2. Plaintiffs were dismissing their claims against GSK for seemingly “no discernible benefit” while their lawyers on the other hand reaped a significant advantage. In return for the dismissals, GSK agreed to drop the sanctions motions and forego any monetary payment in relation thereto. Id. at 15. While concerning on its own, the dominant consideration for the court in deciding to investigate the dismissals was that it “had lost confidence in the [plaintiffs’] lawyers’ ability and willingness to tell the truth about critical facts when addressing the Court.” Id. at 3. Wow. That’s a punch in the gut no lawyer ever wants to receive.

The court ordered the Special Master to “ensure that [plaintiffs’ counsel] obtained the knowing, voluntary consent of each Plaintiff before agreeing to dismiss his or her case against the GSK Defendants with prejudice.” Id. at 17. The Special Master determined that to fulfill this directive, he had to interview each plaintiff directly. First, plaintiffs’ counsel challenged that the court had the power or jurisdiction to do this at all. Plaintiffs argued that because GSK wasn’t opposing the dismissals, the court had no discretion other than to enter them. Rule 41(a)(2), however, provides that dismissal requires a court order and must be “on terms the court considers proper.” Id. at 26. The court wasn’t questioning the terms of the dismissal or whether they were reasonable, only whether plaintiffs were adequately informed and the dismissals were in fact voluntary. Plaintiffs’ counsel’s second road block to the interviews was to suggest that everything the court needed to know could be conveyed via either declarations signed by each of the plaintiffs or in writing in response to a questionnaire. Id. at 19. But as each of those options still contained the possibility of lawyer involvement and may not be a first-hand account, the court rejected them both. Finally, the interviews were conducted in the presence of both plaintiff and defense counsel.

Throughout the process, the Special Master was acutely aware that he was walking right along the edge of the attorney-client privilege and if you read his very detailed report, you’ll see he took great care to make sure the privilege wasn’t violated. But that didn’t stop plaintiffs’ counsel from making statements at the start of each interview about the privilege. Those statements turned into accusations against the Special Master and the court that they were intentionally seeking to violate the privilege and calling the entire process a “sham” and an attempt to “embarrass plaintiffs and their counsel.” Id. at 30-32. We’re not sure plaintiffs’ counsel were in any position to be accusing the court of wrongdoing. Feels a bit like a schoolyard bully whose bluff has been called and his last resort is “I know you are but what am I.”

Left with healthy skepticism about whether plaintiffs’ counsel “painted a picture of a judiciary so hostile, so malevolent, that the Plaintiffs were incapable of making a reasonably informed decision,” but unwilling to violate the attorney-client privilege, the Special Master concluded that each plaintiff demonstrated a cogent rationale for deciding to dismiss his/her claims against GSK while continuing to pursue claims against the other defendants. It appears most learned that GSK had not been involved with thalidomide at the time their mothers’ ingested it. Id. at 28.

The issue must still be resolved by the court, which we do not believe will be very pleased with the way plaintiffs’ counsel conducted themselves throughout the interview process. So, while it is likely the dismissals will be granted, plaintiff’s counsel themselves seem to be in a hole we aren’t sure they’ll ever be able to climb out of.

Earlier this month the FDA issued a draft guidance entitled “Deciding When to Submit a 510(k) for a Change to an Existing Device.” It’s long, and anyone interested in reviewing the whole thing can download it from the FDA’s website here.  Our interest in this draft guidance, as product liability litigators defending FDA-regulated products, is primarily due to the Agency’s numerous statements about when changes to the design and warnings of 510(k) medical device obligates their manufacturers to resubmit their products for additional FDA clearance prior to marketing.

As we’ve already discussed in much more detail in our September, 2015 “In Case of Good Judge, Break Glass” post, if a product change requires prior FDA review and assent, then that change cannot be mandated by common law tort actions.  The Supreme Court stated in PLIVA v. Mensing, 564 U.S. 604 (2011), “The question for ‘impossibility’ [preemption] is whether the private party could independently do under federal law what state law requires of it.” Id. at 620.  The new FDA draft guidance is all about when product changes to 510(k) devices require prior submission and Agency clearance:

This guidance, when finalized, will aid manufacturers of medical devices subject to premarket notification requirements who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (also referred to together as “existing devices”) during the process of deciding whether the modification exceeds the regulatory threshold of 21 C.F.R. §807.81(a)(3) for submission and clearance of a new 510(k).

Draft Guidance at 3 (“Scope”) (emphasis added).

Initially, we remind everyone that this document is both a “guidance” and a “draft.” It is subject to comment and is not final.  Even when final it has no legally binding effect.  But the guidance does interpret legally binding regulations that, as we discussed in our “Break Glass” post, mandate prior FDA review and clearance of changes to 510(k) devices.  The guidance is useful in that it provides a more comprehensive explication of the regulations, and thus more useful understanding of when a requirement for prior FDA submission of a device change gives rise to implied impossibility preemption under Mensing, Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), and Wyeth v. Levine, 555 U.S. 555 (2009).

Here are the principles that we think are most important to that determination.

First, any change that significantly affects a 510(k) device’s safety or effectiveness – and thus essentially any change that could support a causation argument in product liability – requires the submission of a new 510(k) device notification and prior FDA clearance:

Modifications made with intent to significantly affect safety or effectiveness of a device – If a manufacturer modifies their device with the intent to significantly improve the safety or effectiveness of the device (for example, in response to a known risk, adverse events, etc.), a new 510(k) is likely required.  Changes that are not intended to significantly affect the safety or effectiveness of a device, however, should still be evaluated to determine whether the change could significantly affect device safety or effectiveness.

Draft Guidance at 4 (emphasis original).

Manufacturers are required to submit a new 510(k) when a change (or changes) exceeds the §807.81(a)(3) threshold, “could significantly affect the safety or effectiveness of the device,” or constitutes a “major change or modification in the intended use of the device.”

Id. at 9 (quoting regulations).

[T]he first question is always whether the change is being made with the intent to significantly improve the safety or effectiveness of the device, for example, in response to a known risk, adverse event, etc. (Figure 1 – Main Flowchart). If so, then the change likely “could significantly affect safety or effectiveness” and a new 510(k) likely must be submitted.

Id. at 10.

Second, any change that involves an off-label use – that is, a change affecting the “intended use” of the device – also requires submission of a new 510(k) device notification and prior FDA clearance:

The concept of intended use has particular relevance in determining whether a device can be cleared for marketing through the premarket notification (510(k)) process or must be evaluated in a premarket approval application (PMA) or a de novo request for classification under section 513(f)(2) of the FD&C Act. Manufacturers should recognize that, per section 372513(i) of the FD&C Act, if a particular labeling change results in a different intended use of the device, the device would not be substantially equivalent and a PMA or a de novo submission would be required to market the device.

Draft Guidance at 11 (emphasis added).

Changes in the indications for use section of labeling raise more Agency concern than any other aspect of labeling. In fact, most changes in this part of the labeling that affect the substance, meaning, or scope of the indications for use – referred to here as “substantive changes” – could significantly affect safety or effectiveness and will require the submission of a new 390 510(k).

Id. at 12.

[I]f a design change significantly affects how a device may be used, a new 510(k) is likely required.

Id. at 25.

Third, changes to the composition of the device that affect its safety or effectiveness require requires submission of a new 510(k) device notification and prior FDA clearance:

Manufacturers should consider whether the material change could affect the performance of the device by affecting its strength, hardness, etc. Manufacturers should also consider whether the new material could be affected by any labeled cleaning, disinfection, or sterilization process of the device.  If the answer to this question is yes, manufacturers should . . .  consider whether the change could significantly affect the safety or effectiveness of the device.

Draft Guidance at 31.

Fourth, certain other label changes also require submission of a new 510(k) device notification and prior FDA clearance:

Deletion or modification of a contraindication usually requires the submission of a new 510(k) prior to effecting the change.

Draft Guidance at 16.

If the change significantly affects the device’s risk profile, a new 510(k) is likely required.

Id. at 17 (note, that in many “risk profile” changes, the changes being effected (“CBE”) process would be available, thus precluding preemption under Levine).

Finally, the draft guidance also discusses a wide variety of other device alterations that could trigger an obligation to submit a new 510(k) notification to the FDA, such as changes to sterilization (pp. 21-22), that could conceivably be relevant in specific litigation situations. Any of our defense-side colleagues facing a peculiar claim should review the entire guidance to see if prior FDA action is required by whatever change the plaintiff is demanding.

When we wrote our “Break Glass” post back almost a year ago, there were only a few district court cases applying Mensing/Bartlett preemption outside of generic drugs.  Now there is a lot more helpful precedent (see our post-Levine preemption cheat sheet).  We have several new cases preempting branded drug design defect cases because prior FDA approval of major changes is required. Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015) (affirming a decision cited in our prior post); Brazil v. Janssen Research & Development LLC, ___ F. Supp.3d ___, 2016 WL 3748771 (N.D. Ga. July 11, 2016); Fleming v. Janssen Pharmaceuticals, Inc., ___ F. Supp.3d ___, 2016 WL 3180299 (W.D. Tenn. June 6, 2016); Barcal v. EMD Serono, Inc., 2016 WL 1086028 (N.D. Ala. March 21, 2016); Rheinfrank v. Abbott Laboratories, Inc., 137 F. Supp.3d 1035 (S.D. Ohio 2015); and Rheinfrank v. Abbott Laboratories, Inc., 119 F. Supp.3d 749 (S.D. Ohio 2015) (which had been decided before our earlier post, but we didn’t know about yet).

Mensing/Bartlett preemption has also been extended to OTC drugs. Batoh v. McNeil-PPC, Inc., ___ F. Supp.3d ___, 2016 WL 922779 (D. Conn. March 10, 2016).

Branded drug warning claims involving information not subject to the CBE exception to prior FDA approval of significant changes has also been recognized. In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015) (information wasn’t “new”); In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, ___ F. Supp.3d ___, 2016 WL 2840215 (D.S.C. May 6, 2016) (information related to efficacy, not safety).

Mensing/Bartlett preemption has even been applied outside of the FDCA altogether – to bar airplane design claims requiring prior FAA approval – in Sikkelee v. Precision Airmotive Corp., 822 F.3d 680, 703-04 (3d Cir. 2016).

It’s inevitable – barring a change in the composition of the Supreme Court that leads to the overturning of Mensing and Bartlett – that implied impossibility preemption will come to 510(k) medical devices.  Three circuits (1st, 3rd, and 6th) have already applied it outside of generic drugs.  Unlike express preemption (such as Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)), implied preemption isn’t limited to the express terms of particular statutes, and as we discussed in the “Break Glass” post, express and implied preemption operate independently of one another, so Lohr doesn’t restrict the operation of implied preemption.

For us, this is the reason that the FDA’s 510(k) draft guidance is important (although it does other things, too, like debunking the bogus argument that 510(k) clearance doesn’t involve”safety”). Since the key to impossibility preemption, as Mensing held “is whether the private party could independently do under federal law what state law requires of it,” the draft guidance provides a wealth of FDA regulatory explanation of why certain types of changes to the design, labeling, and other features of 510(k) medical devices necessitate prior FDA clearance − and thus cannot be demanded by plaintiffs in common-law product liability litigation.

It’s August and several your valiant bloggers are on vacation, so the skeleton crew manning the fort is even more grateful for reinforcements than usual.  Here is another guest post, this time from Reed Smith‘s Court Chillingworth.  This is about a topic we’ve covered sporadically, the Biomaterials Access Assurance Act.  As always Court is entitled to full credit (and any blame) for everything appearing hereafter.  Except for this:  Edgar Allen Poe wrote on both.  Don’t worry, you’ll understand what it means by the end of Court’s post.

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When is a medical device an implant? When is it not? While far more drab than anything Lewis Carroll would have written, it is still a multi-layered riddle, and one that should be of particular curiosity – and possibly concern – to present-day medical device lawyers. It derives from the Biomaterials Access Assurance Act (“BAAA”), 21 U.S.C. §§ 1601 et seq., a statute that shields from liability in all state and federal courts the manufacturers of biomaterial and component parts that are supplied “for use in the manufacture of an implant.” Id., § 1601(1)(A) (emphasis added); see also id. § 1601(2), 1603(b)(1), 1604(a).  A Connecticut trial judge recently explored the question in Nolen-Hoeksema v. Maquet Cardiopulmonary AG, No. 146049888S, 2016 WL 4203030 (Conn. Super. New Haven Dist. July 11, 2016), and in particular, the question of whether one of the statute’s definitions of an “implant” – a device that is intended be “in contact with bodily fluids or internal human tissue through a surgically produced opening” [21 U.S.C. § 1602(5)(A)(ii) (emphasis added)] – would apply to a medical device that is used during surgery, but is not designed to be in direct contact with the patient.

Ultimately, the court found its answer from an otherwise simplistic source:  the Webster’s Dictionary and its definitions of the word “through.” But its analysis, which involved principles of statutory interpretation and federal preemption, was complex: which one of two Webster’s Dictionary definitions of the word “through” should be applied – one advocated by the defendant, meaning “by way of” in the abstract, or one advocated by the plaintiff, meaning “penetrating.” The court chose the latter, which effectively would require direct contact between the device and the patient for the BAAA to apply to component parts of the device under 21 U.S.C. § 1602(5)(A)(ii).

In Nolen-Hoeksema, the device at issue, an oxygenator, allegedly “fell apart” during the patient’s surgery, leading to the decedent’s death. Nolen-Hoeksema, 2016 WL 4203030, *1. His family sued the oxygenator’s manufacturer, as well as the manufacturer of the adhesive material used to keep the oxygenator assembled. Id. The adhesive manufacturer filed a motion to dismiss on BAAA grounds. As this blog has noted, component part manufacturers have applied the BAAA defense with virtually universal success.  See, e.g., Sadler v. Advanced Bionics, LLC, 2013 WL 1636374 (W.D. Ky. April 16, 2013); Mattern v. Biomet, Inc., 2013 WL 1314695 (D.N.J. March 28, 2013); Whaley v. Morgan Advanced Ceramics, Ltd., 2008 WL 901523 (D. Colo. March 31, 2008); Marshall v. Zimmer, 1999 WL 34996711 (S.D. Cal. Nov. 4, 1999). The court in Nolen-Hoeksema acknowledged these cases, but drew a distinction – none of them involved the question of whether a medical device that is not in direct contact with the patient qualifies as an “implant” under the BAAA.  Nolen-Hoeksema, 2016 WL 4203030, at *4 n.3.

To argue their points, both parties directed the court to the definitions of “through” in the Webster’s Dictionary (Webster’s Third International Dictionary (1993), to be exact).  According to the plaintiff, “through a surgically produced opening” meant literally through, as in physical, functional “penetration of or passage within” the opening, as one of Webster’s definitions described the word. Id. at *3. But the defense countered that Webster’s also defined “through” “in the more general sense of ‘by means of’” [id.], as in, “the author made a poor attempt at levity in his article through strained allusions to Alice in Wonderland.”

Down the rabbit hole went the court to determine which definition would apply. The court’s first step was to decide what principle of statutory interpretation it should apply. Because the BAAA is a federal statute, it found that under Connecticut precedent, it had to apply the rule of construction utilized by the U.S. Second Circuit.  Id. at *2. The Second Circuit “begin[s] with the text of the statute to determine whether the language at issue has a plain and unambiguous meaning. . . . [The court] attempt[s] to ascertain how a reasonable reader would understand the statutory text, considered as a whole.” Id. (quoting Louis Vitton Malletier S.A. v. LY U.S.A., Inc., 676 F.3d 83, 108 (2d Cir. 2012).

Given the BAAA’s explicit recognition that raw material and component suppliers “have ceased supplying certain raw materials and component parts for use in medical devices for a number of reasons, including concerns about the costs of such litigation” [21 U.S.C. § 1601(8)], a reasonable reader may agree with the defense interpretation of what is, after all, a remedial statute. One might argue that the defense’s broader interpretation is not just reasonable, but more appropriate than the alternative interpretation, in light of the BAAA’s goal to offset the discouraging effect litigation has on potential raw material and component suppliers. But while the court preliminarily cited this portion of the statute’s language [Nolen-Hoeksema, 2016 WL 4203030, at *1], it did not consider the language in its eventual analysis. Id. at *3-4. Instead, it looked outside the statute – indeed outside statutory interpretation altogether − to the “presumption against preemption.”  That is, “where the text of a preemption clause,” which the BAAA is, since it bars any state law personal injury claims against medical implant component suppliers, “is ambiguous or open to more than one plausible reading, courts have a duty to accept the read that disfavors pre-emption.”  Id. at *3 (citing New York State Restaurant Ass’n v. Board of Health, 556 F.3d 114, 123 (2d Cir. 2009)). Here, on the one hand, the defendant offered an interpretation of “through” that would “preempt state law in a greater number of cases,” while on the other, “the plaintiff construes it more narrowly.” Nolen-Hoeksema, 2016 WL 4203030, at *3. Given the two potential interpretations of the word “through,” the court sided with the interpretation that would have a lesser preemptive effect – thereby effectively ignoring what Congress intended to achieve through the BAAA.

With all that jabberwocky out of the way, the court finally got to what was probably its first gut reaction, which was to rely on what it understood to be the “ordinary meaning” of the word “implant.” Id. at *4. To this end, the court once again turned to the Webster’s Dictionary, which defined “implant” as “something that is ‘fix[ed] or set securely or deeply,’ ‘[especially] in tissue.’” Id. Since the undisputed evidence (That’s right, evidence. BAAA authorized submission of evidence in connection with a motion to dismiss, even in state court. See 21 U.S.C. §§ 1603(a)(2), (c)(1); see also Nolen-Hoeksema, 2016 WL 4203030, at *2 n.2 (BAAA procedure applies in state court)) showed that the oxygenator “is not inserted into the patient’s body,” it did not fit with the “common understanding” of the word “implant.” Id. Motion denied.

So, when is a medical device an implant under the BAAA? “Either [it] is, or [it] is not,” quoth the court. Id. at *4 n.4. According to the court’s reading of the dictionary, an oxygenator is not, and therefore its components do not qualify for the BAAA defense. Next question: Why is a raven like a writing desk?

If you represented a large corporation or a wealthy individual, wouldn’t you want to know if your prospective jurors were campaigning for Bernie Sanders on Facebook? Or how about criminal prosecutors who might want to know if members of their jury panel had posted strong feelings on police conduct?  If you were adverse to a drug or medical device company, maybe you would want to know if a prospective juror wrote for the Drug and Device Law Blog (although we can guarantee that you will find no more thoughtful and impartial jurors than the seven individuals who make up the collective “we”).

Millions of potential jurors make information like this (and much more) publicly available on the Internet through social media or otherwise, and what trial advocate would not want to uncover it? We got to thinking about this topic a few months ago when we read a unique order that came out of the Northern District of California in Oracle America, Inc. v. Google Inc., ___ F. Supp.3d ___, 2016 WL 1252794 (N.D. Cal. Mar. 25, 2016).  The district judge in Oracle v. Google asked the parties in a high-stakes copyright action to abstain voluntarily from searching the jury panel’s social media.  If the parties would not agree to a complete ban, then the court would impose specific limitations.

We’ll get to the details in a minute. But first, we set out to see if there are any rules that govern searching jurors’ social media (with research assistance from Reed Smith attorney David Chang).  It turns out there are, mainly within the rules of ethics and professional conduct.  The first rules obviously are our duties of competence and diligence.  They are among the first duties listed under the ABA’s Model Rules and probably the rules governing lawyers in most every state. See Model Rules of Professional Conduct, Rules 1.1, 1.3.  If there is publicly available information that would help us identify jurors with potential biases, a competent and diligent trial advocate needs to consider gaining access to it.

There are, however, countervailing considerations. On April 14, 2014, the ABA’s Standing Committee on Ethics and Professional Responsibility published “Formal Opinion 466, Lawyer Reviewing Jurors’ Internet Presence.”  The ABA committee’s opinion came on the heels of an opinion from the Association of the Bar of the City of New York—“Formal Opinion 2012-2, Jury Research and Social Media.”  These are not the only publications on the topic, but they were at the cutting edge, and they cover the major considerations.

The opinions identify essentially three additional issues that you have to keep in mind:

No ex parte communications with jurors. Of course, we cannot engage in ex parte communications with jurors or prospective jurors.  We remember when we were Summer Associates and were told that if we talked to a juror, we would be fired.  Kind of a strange threat to make against a bunch of wide-eyed second-year law students who stood a snowball’s chance in hell of actually being in the presence of a jury.  (Rumor has it that such an incident actually occurred the prior summer, but we never learned any details.)  In any event, ABA Model Rule 3.5 prohibits ex parte contact with jurors, and everyone seems to agree that affirmatively reaching out to a juror on social media—i.e., to “friend,” “connect with,” or “follow” the juror—clearly would violate that rule.  Passive viewing of juror’s Internet presence is probably okay, depending on whether the juror receives notice of the surveillance.  If a juror received notice of your snooping, for example through an automated message that someone has “viewed your profile,” that is okay under the ABA’s Opinion, but it might be an ex parte communication under some state’s rules, including New York’s.  So be careful and tread lightly.

No deception. There are lots of rules that prohibit deception, but we follow the one that a now-retired and much-admired mentor shared with us repeatedly:  “You can’t do that.”  The ABA Opinion curiously does not mention deception, but the NYC Bar Opinion says flat out, “The attorney must not use deception to gain access to a juror’s website or to obtain information.”  So, no, you cannot troll for information on your jurors through a Facebook profile pretending to be a 24-year-old single woman seeking a roommate, or a 54-year-old divorced male who likes waterskiing and long walks on the beach at sunset (unless you happen to be one of those things).  If you search your jurors’ social media, either log in truthfully or don’t log in at all.

Report any juror misconduct. Judges admonish jurors repeatedly that they cannot discuss the case with anyone or engage in their own investigation, and that includes through the Internet and social media.  Still, we hear stories of jurors describing trials on Facebook and even expressing their opinions on the case.  If your social media searches turn up commentary that violates the court’s instructions, you have to reveal it to the court.  You might be thinking, as we did, why on Earth would an attorney not reveal misconduct to the court?  Well, the misconduct might reveal a juror’s bias in your favor.  Maybe she thinks your opening was great or that your experts absolutely killed it on direct.  It doesn’t matter.  If a juror has engaged in misconduct and you learn about it by monitoring social media, you have to tell the judge.

These are the ground rules against which the Northern District of California approached the parties’ intent to search their prospective jurors’ Internet and social media presence in Oracle v. Google.  As of the time of the March 25, 2016 order, one side had not agreed to the court’s request to abstain from searching the jurors’ social media, so the district judge asked them again to agree.  If they would not, the court would inform the jury panel of the “specific extent” to which each side would use Internet searches.  The judge then would give the panel “a few minutes to use their mobile devices to adjust their privacy settings, if they wish.”  2016 WL 1252794, at *3.

There are some things we like about this solution. We like that the court is forward thinking and is looking out for the jurors’ interests in a twenty-first century world.  Not many courts understand privacy settings, or even know what privacy settings are.  This court thoroughly educated itself.  We also like that the district court did not impose an outright ban on social media searches.  A federal court may or may not have the authority to impose such a ban, but assuming that it does, a complete ban would hamstring attorneys (who are bound by duties of competence and diligence) in their efforts to engage in legitimate evaluation of public information.

The order does, however, raise important questions. The court was concerned that allowing social media searches (including telling the jurors what the attorneys were doing) “will likely have a corrosive effect on fidelity to the no-research admonition.” Id. at *2.  In another words, if the attorneys are searching the Internet, then the jurors may feel justified in disregarding the court’s admonition.  There is certainly a risk of that, but it is uncertain to us how significant that risk would be.  It is just as possible that jurors would take the admonition just as seriously whether the lawyers viewed their public profiles or not—particularly if the court instructed them that the difference is based on their role as impartial jurors, which is different from lawyers as advocates

Second, the court cited the danger of attorneys making “improper appeals to particular jurors via jury argument and witness examinations patterned after preferences of jurors found through such Internet searches.” Id. That also is a risk, but it is not unique to the Internet.  The voir dire process, often supplemented by detailed juror questionnaires, also reveals jurors’ preferences and attitudes.  That is the reason for the process, and ever since voir dire was invented, lawyers have known and used such information as they present their cases.

Third, the court wanted to protect the jurors’ privacy. Id. This is always a laudable goal, but we have to ask whether the court valued the jurors’ privacy more than the jurors themselves.  We are continually amazed by what people choose to post on Facebook (see our posts on ediscovery of plaintiff social media), even people with senses of social responsibility sufficient to show up for jury duty.  On this point, the court struck a compromise:  Give the panel members some level of control by allowing them the opportunity to adjust their privacy settings.  If the court followed this path, we would be interested to know how many took the court up on its offer.

The takeaway is not that this order is right or wrong. Either way, attorneys should understand first that rules apply, and they should understand second that issues surrounding juries and the Internet will get only more pervasive as time goes on.