Photo of Bexis

JAMES M. BECK is Counsel resident in the Philadelphia office of ReedSmith. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He has been a member of the American Law Institute (ALI) since 2005. He is the long-time editor of the newsletter of the ABA's Mass Torts Committee.  He is vice chair of the Class Actions and Multi-Plaintiff Litigation SLG of DRI's Drug and Device Committee.  He can be reached at jmbeck@reedsmith.com.  His LiinkedIn page is here.

Bexis gave a talk the other day at the Washington Legal Foundation on personal jurisdiction after last term’s United States Supreme Court decisions in Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017) (“BMS”), and BNSF Railway Co. v. Tyrrell, 137 S. Ct. 1549 (2017) (“BNSF”).  One of the highlighted areas of emerging jurisdictional issues was MDL practice – specifically the MDL practice of allowing plaintiffs anywhere in the country to “direct file” actions into the MDL after it has been established – thereby bypassing the provisions of the MDL statute, 28 U.S.C. §1407(a) that “transfers shall be made by the judicial panel on multidistrict litigation.”

We thought we’d examine that a bit today.

Essentially, we don’t think that there is any jurisdictional basis for direct filing – except the defendants’ waiver of any jurisdictional challenge.  Initially, the MDL statute itself does not confer such jurisdiction.  The statute nowhere mentions direct filing, and in only one instance is an MDL judge (also called the “transferee court”) clothed with extraordinary jurisdictional powers.  That has to do with depositions.  See 28 U.S.C. §1407(b) (MDL judge “may exercise the powers of a district judge in any district for the purpose of conducting pretrial depositions”).

Whether or not the legal maxim “expressio unius est exclusio alterius” (express mention of one item implies the exclusion of others of the same ilk) should apply here, we seriously doubt that Congress intended to hide any jurisdictional elephants in MDL statutory mouseholes.  Cf. Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26, 40-41 (1998) (refusing to imply MDL court jurisdiction to try transferred cases).  It “may or may not” be more efficient to allow direct filings, but the MDL statute does not so state, so “the proper venue for resolving that issue remains the floor of Congress.”  Id. at 40 (citations omitted).  We further note that the Judicial Panel on Multidistrict Litigation’s rule that has been interpreted as allowing direct filing, J.P.M.D.L.R 7.2(a), likewise does not mention jurisdiction – providing only that “[p]otential tag-along actions filed in the transferee district do not require Panel action.”

In BNSF (previously discussed here) the Supreme Court rejected an attempt to use a statute (the venue provision of the Federal Employees’ Liability Act) to create personal jurisdiction where it did not otherwise exist.  When Congress intends to expand jurisdiction (as opposed to venue) it “typical[ly]” does so by “authoriz[ing] service of process.”  137 S. Ct. at 1555 (list of examples omitted).  This statute did not expressly do so, and to the extent any prior precedent suggested otherwise, that precedent was obsolete:

[A]ll these cases . . . were decided before this Court’s transformative decision on personal jurisdiction in International Shoe Co. v. Washington, 326 U.S. 310 (1945).  See [Bauman], 134 S. Ct. [746], 761, n.18 (cautioning against reliance on cases “decided in the era dominated by” the “territorial thinking” of Pennoyer v. Neff, 95 U.S. 714 (1878)).

Id. at 1555-56 (citations modified).  We’ve already raised this cautionary note with respect to century-old precedent in jurisdiction by consent cases, but it applies more broadly.

Demise of their statutory arguments left the plaintiffs in BNSF with nothing but state law to rely on.  While the defendant “ha[d] over 2,000 miles of railroad track and more than 2,000 employees” in the state, that was insufficient to permit suit by non-resident plaintiffs under either general or specific jurisdictional principles:

[T]he business BNSF does in [the state] is sufficient to subject the railroad to specific personal jurisdiction in that State on claims related to the business it does in [the state].  But in-state business . . . does not suffice to permit the assertion of general jurisdiction over claims like [plaintiffs’] that are unrelated to any activity occurring in [the state].

Id. at 1559 (footnote omitted).

Turning to BMS, which was a mass tort worthy of a breaking news post, hundreds of plaintiffs filed in California to escape (among other things) an existing federal MDL.  Non-resident plaintiffs could not establish specific personal jurisdiction over a non-resident defendant, even though (like BNSF) resident plaintiffs could, and the non-residents might be able to sue a different defendant that was “at home” in that state.  “The primary focus of our personal jurisdiction inquiry is the defendant’s relationship to the forum State.”  137 S. Ct. at 1779.  Jurisdiction is “a consequence of the territorial limitations” on state power; therefore even a ‘convenient location for litigation’ may, as a consequence ‘of interstate federalism,’ be “divest[ed]. . . of its power to render a valid judgment.”  Id. at 1781 (quoting World-Wide Volkswagen Corp. v. Woodson, 444 U.S. 286, 294 (1980)).

Specific jurisdiction, as explained in BMS, requires “an affiliation between the forum and the underlying controversy, principally, an activity or an occurrence that takes place in the forum State.”  Id.  “[U]nconnected activities,” no matter how extensive, are irrelevant.  Id.  That “other,” in-state plaintiffs could bring suit was “an insufficient basis for jurisdiction,” as was the ability of the non-resident plaintiffs to sue other, in-state defendants.  Id. at 1781, 1783.  Jurisdictional requirements “must be met as to each defendant over whom a state court exercises jurisdiction.”  Id. at 1783 (citation and quotation marks omitted).  Where:

[t]he relevant plaintiffs are not [in-state] residents and do not claim to have suffered harm in that State[, and] all the conduct giving rise to the nonresidents’ claims occurred elsewhere[, i]t follows that the [state’s] courts cannot claim specific jurisdiction.

Id. at 1782 (citation omitted).  Mass tort plaintiffs have two choices after BMS:  they can all sue “in the States that have general jurisdiction” over a particular defendant, or “plaintiffs who are residents of a particular state . . . could probably sue together in their home States.”  Id. at 1873.

Returning to MDLs, as in BNSF, there is no “typical” jurisdictional provision anywhere in the MDL statute.  Unless a particular MDL happens to be located in a forum with “general jurisdiction” over a defendant, there is no constitutional basis for allowing plaintiffs anywhere in the country to file directly into the MDL and thereby bypass statutory procedures.  Further, since jurisdiction must exist “as to each defendant” individually, in MDLs with more than one major defendant (most MDLs), it is unlikely (albeit not impossible) for there to be any jurisdiction where all such defendants are “at home” so as to permit direct filing as a matter of constitutional Due Process.

Thus, the only jurisdictional basis for MDL direct filing is the acquiescence – and thus the waiver – of the defendant(s) being sued.  That is particularly dangerous in an MDL setting, as the recent decision in the Pinnacle Hip MDL litigation (discussed here) exemplifies.  See In re Depuy Orthopaedics, Inc., 870 F.3d 345 (5th Cir. 2017).  The defendants’ agreement to a direct filing order was – wrongly, a majority of the Court of Appeals held – interpreted as a waiver of jurisdictional objections.  Id. at 351-52.  As for the propriety of direct filing, there was no majority.  The lead opinion viewed direct filed cases as being “treated ‘as if they were transferred from a judicial district sitting in the state where the case originated.’”  Id. at 348 (quoting In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 2011 WL 1375011, at *6 (S.D. Ill. April 12, 2011)).  The first concurrence declined to reach the issue.  Id. at 356-57.  The second, concurring and dissenting, opinion would find direct filing invalid:

But for the possibility of a “global waiver” of personal jurisdiction, the [MDL court] had no claim to personal jurisdiction over the cases:  none of the plaintiffs’ surgeries occurred in [the state]; the plaintiffs aren’t [in-state] residents; and neither general nor specific jurisdiction exists over the [defendants] for purposes of these disputes.  For that reason, the district court relied solely on the “global waiver”. . . .  Petitioners are being forced to trial over their objections to personal jurisdiction.

By comparison, a scholarly opinion . . . in an MDL case resulted in dismissal of a nonresident defendant against which there was a “direct filed” case by a nonresident plaintiff.  In re Heartland Payment Systems, Inc. Customer Data Security Breach Litigation, 2011 WL 1232352 (S.D. Tex. March 31, 2011).  The court first noted that the defendant’s agreement to transfer for purposes of pretrial proceedings was not inconsistent with and did not waive its personal jurisdiction challenge.  2011 WL 1232352 at *5–6.  Finding no waiver, the court then decided that it lacked personal jurisdiction over the non-consenting defendant based on [its] lack of minimum or relevant contacts with the [state in question]. 2011 WL 1232352 at *6–10.

Depuy Orthopaedics, 870 F.3d at 357.

This is a good place to start, so we examined the decisions cited by both sides.  Looking at Yasmin/Yaz, we were disappointed.  That decision doesn’t even discuss the jurisdictional ramifications of MDL direct filing.  Rather, as the first sentence of the opinion makes clear, “[t]his matter is before the Court for the purpose of resolving choice of law considerations.”  2011 WL 1375011, at *1.  The direct filing order at issue specified that direct filing would have no effect on choice of law.  Id. at *4 n.2, so the reference in Yasmin/Yaz to how direct filings were “treated” occurred in the context of deciding what “no effect” on choice of law meant:

As to the foreign direct filed cases, the choice of law decision is not as clear.  Foreign direct filed cases are filed in this Court pursuant to a direct filing order . . . [that] expressly provides that the parties’ direct filing agreement will not impact the choice of law that otherwise would apply to the direct filed actions.

In general, direct filing orders are beneficial to both parties because they streamline the litigation and help to eliminate the judicial inefficiency. . . .  However, direct filing orders also present difficult choice of law issues. . . .  The Court concludes that the better approach is to treat foreign direct filed cases as if they were transferred from a judicial district sitting in the state where the case originated.  For purposes of this analysis, the Court considers the originating state to be the state where the plaintiff purchased and was prescribed the subject drug.

Id. at *5-6 (citations omitted).  There is not one mention of personal jurisdiction in the entire Yasmin/Yaz opinion.

Turning instead to Heartland Payment, that case did involve a dispute over personal jurisdiction in a directly filed action.  See 2011 WL 1232352, at *4 (observing that “direct filings may present jurisdictional, venue, or related issues”).  The defendant moved to dismiss a direct filed action under Fed. R. Civ. P. 12(b)(2) on the ground that the state in which the MDL was situated had no personal jurisdiction over it.  Id. at *5.  March, 2011 was, of course, three years before Bauman was decided and even several months before the Supreme Court’s “at home” test debuted in Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915 (2011).  But even under the more lax standards of that time, personal jurisdiction did not lie simply because an MDL against the defendant happened to exist in the state in question.

As in Depuy Orthopaedics, the MDL plaintiffs in Heartland Payment first attempted to use the defendant’s agreement to direct filing as a waiver of personal jurisdiction.  2011 WL 1232352, at *7.  Unlike Depuy Orthopaedics, the MDL court in Heartland Payment rejected that argument.  Id.  As for specific jurisdiction, neither the defendant’s use of an in-state processing center nor its agreements with national credit card networks sufficed.  “[M]erely contracting with a resident of the forum state is insufficient to subject the nonresident defendant to personal jurisdiction in that state.”  Id. at *8.  Plaintiff did not even try to argue that the fortuitous, after-the-fact creation of an MDL in the jurisdiction could be a “minimum contact” justifying jurisdiction.  Without a basis for jurisdiction, the directly filed case had to be either transferred or, if the parties could not agree, dismissed.  Id. at *12, 14.

On the basis of these two cases, we’d have to give the edge to the dissent on the jurisdictional issue, since Heartland Payment decided the question at issue – the jurisdictional impact of MDL direct filing – while Yasmin/Yaz did not.  But is there anything else out there, other than these two opinions, decided two weeks apart, in 2011?

We took a look, but most of what we found were either MDL orders creating negotiated direct filing regimes, or cases, like Yasmin/Yaz, that dealt with the impact of direct filing on substantive choice of law issues.  See, e.g., In re Incretin Mimetics Products Liability Litigation, 2013 WL 12171761 (S.D. Cal. Nov. 13, 2013) (an example of the former); Wahl v. General Electric Co., 786 F.3d 491, 498-99 (6th Cir. 2015) (an example of the latter).  Other than that, it appears that the two 2011 precedents are pretty much all there is.  The issue was raised in In re New England Compounding Pharmacy, Inc. Products Liability Litigation, 2015 WL 178130 (D. Mass. Jan. 13, 2015), but mooted by plaintiffs refiling in their home jurisdiction and getting a JPMDL “tag along” order before it could be decided.  Id. at *1 n.3.  The court in In re Vioxx Products Liability Litigation, 478 F. Supp.2d 897, 904 n. 2 (E.D. La. 2007), noted the possibility that “the MDL forum” might not be able to “exercise personal jurisdiction over the defendant” in discussing direct-filed complaints, but that was an aside in another choice of law decision.  A direct-filed case was dismissed for lack of subject matter jurisdiction in In re Pradaxa (Dabigatran Etexilate Products Liability Litigation, 2014 WL 7145470, at *3 (S.D. Ill. Dec. 15, 2014), where the plaintiffs were from a foreign country – but personal jurisdiction was not discussed.  Thus, it appears that Depuy Orthopaedics and Heartland Payment are the only cases actually addressing personal jurisdiction in the context of direct-filed MDL actions.

In the context of an ordinary (non-MDL) transfer, the Supreme Court has sought to “ensure that the ‘accident’ of federal diversity jurisdiction does not enable a party to utilize a transfer to achieve a result in federal court which could not have been achieved in the courts of the State where the action was filed.”  Van Dusen v. Barrack, 376 U.S. 612, 638 (1964).  We think that this principle logically extends to personal jurisdiction – and to direct filed actions.

In MDLs that rest – as product liability litigation does – on state law and diversity of citizenship, there is no jurisdictional basis for direct filing of MDL actions other than the defendant’s waiver of their rights to assert lack of personal jurisdiction.  The Supreme Court’s recent jurisdictional decisions, culminating (so far; there will be more) with BMS and BNSF, have put the other side’s mass tort business model in significant jeopardy.  Thus, we see plaintiffs making extreme and exorbitant waiver arguments based on MDL direct filing agreements, not only in Depuy Orthopaedics, but also in the earlier Heartland Payment case, which also involved an aggressive waiver claim.  Our best advice is “don’t do it anymore.”  There is no statutory basis for personal jurisdiction in a direct filed MDL case, and Lexecon indicates that the Supreme Court won’t be inclined to create one.  Except for the rare MDL located in a place where every defendant is “at home,” there is no constitutional basis for direct filing creating personal jurisdiction either.

Weighing all these considerations, and given how the jurisdictional law is evolving, it is not a good idea for a defendant to waive any personal jurisdiction defense at this time.  Thus, we believe that there is no constitutional basis for personal jurisdiction in direct-filed MDL cases, and defendants should not do plaintiffs any favors by voluntarily agreeing to such procedures.

With PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), preemption arguments in cases involving generic prescription drugs has become a little like shooting fish in a barrel, as our generic preemption scorecard documents.  Still, that’s no reason not to praise good results.  Recently, the manufacturers of generic amiodarone scored two big wins on the same day.  Moore v. Zydus Pharmaceuticals (USA), Inc., ___ F. Supp.3d ___, 2017 WL 4365162 (E.D. Ky. Sept. 29, 2017); Bean v. Upsher-Smith Pharmaceuticals, Inc., 2017 WL 4348330 (D.S.C. Sept. 29, 2017).  Moore, which is headed for F. Supp. publication, is the more comprehensive case, so we’ll start with it.

The plaintiffs’ pitch, such as it is, in these cases is that the generic defendants either piggybacked on the branded manufacturer’s earlier off-label promotion or else engaged in such promotion themselves.  Secondarily, they claim that they didn’t receive the medication guide that the FDA requires manufacturers of this product to provide to prescribing physicians.  Somehow, the failure of the prescriber to pass along this pamphlet is the manufacturer’s fault.

Didn’t work (mostly) in Moore.  As for the off-label promotion allegations, they were barred – as other information-related claims involving generic products are barred – because “the generic drug manufacturer could not change its labeling without violating FDA regulations.”  Moore, 2017 WL 4365162, at *3 (citing Mensing).  Further, the entire concept of “off-label” is derived from the FDA-approved label, and thus from the Food, Drug & Cosmetic Act (“FDCA”).  Id. at*7.  Plaintiff’s attempt to gin up a state-law negligence claim based on this alleged conduct ran straight into a quirk of Kentucky law that we’ve blogged about before:  Kentucky, by statute, prohibits negligence per se claims based on violations of federal law.

The Kentucky Supreme Court’s holding in T & M Jewelry, Inc. v. Hicks ex rel. Hicks, 189 S.W.3d 526, 530 (Ky. 2006) offers binding and unequivocal precedent concerning the scope of KRS 446.070 and demonstrates that [plaintiff] does not have a state based right to sue for negligence in this matter.

*          *          *          *

Under Kentucky law and the Kentucky Supreme Court’s analysis of KRS 446.070, which codifies the doctrine of negligence per se, . . . the statute “did not intend for KRS 446.070 to … confer a private civil remedy for” violations of federal law.

Moore, 2017 WL 4365162, at *7-8.  Aside from the off-label aspect, all warning claims were preempted under Mensing.  Id. at *8-9.  Plaintiff did not allege design- or manufacturing-related claims.  Id. at *8.

As for the purported failure to supply the FDA-mandated medication guide, that was something that the plaintiff simply made up.  Kentucky, like every other state, follows the learned intermediary rule.  Id. at *6.  The manufacturer thus has no obligation, “non-delegable” or otherwise, to communicate warnings directly to a patient who has been prescribed a drug.  Id.  Because there is no such state-law duty, any obligation to supply medication guides was imposed solely by the FDCA.  The FDCA, however, “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance.”  Id. at *5 (quoting Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 349 n.4 (2001)).

Since [plaintiff’s] claim concerning receipt of the medication guide exists exclusively due to the federal regulatory scheme, her claim must fail as the cause of action is merely based upon alleged violation of the FDCA and it is the FDA, not [plaintiff], that “has at its disposal a variety of enforcement options that allow it to make a measured response to suspected fraud upon the Administration.”

Id. (again quoting Buckman, 531 U.S. at 349).

Implied warranty claims were preempted for the same reasons as negligence and strict liability claims.  Id. at *9.  Express warranty claims failed because there was nothing the “explicitly warranted” the drug’s safety for the off-label use in question.  Id. at *10.  Without any express language, the warranty claim was simply a doomed repackaging of plaintiff’s preempted warning claim.  Id. at *11.

The only claim that could conceivably survive preemption in Moore was a fraud claim based on false off-label promotion.  As we’ve seen numerous times in PMA preemption, while every other aspect of off-label promotion was protected by preemption, an allegation that was both false and an FDCA violation could survive – if a plaintiff ever properly pleaded it.  The plaintiff in Moore didn’t come close:

The majority of the complaint fails to specify actions undertaken by [defendant] and instead conflates accusations of wrongdoing against the two originally named “Defendants.”  Instead of providing specific details concerning when the wrongful conduct took place, the Complaint alleges that the “Defendants’ scheme in the past involved and continues to involve a calculated and deceitful sales campaign. . . .”

Id. at 12.  The complaint was such a mess that “it is unclear whether providing [plaintiff] with an opportunity to amend her complaint would be futile.”  Id.  The court decided to give her one more shot.  Id.

The second preemption win, Bean, 2017 WL 4348330, was mostly along the same lines, except that, being from South Carolina, the Kentucky quirk on negligence per se wasn’t at issue.  The plaintiff made same the allegations about off-label promotion and medication guides.  Id. at *1-4.  The court was even firmer about preemption, not allowing any loophole for “fraudulent” off-label promotion:

Plaintiff’s “off-label” promotion claims are due to be dismissed as preempted under Mensing and Bartlett. . . .   The basis for Plaintiff’s “off-label” marketing claim is that Defendants, by virtue of their marketing of [the drug off-label], rendered the manufacturer’s warning inadequate.  Defendants are prohibited by the FDCA and FDA regulations from adding or strengthening any warnings for [the drug] to address any risks associated with off-label use.  If successful, Plaintiff’s “off-label” promotion claims would necessarily require Defendants to either: 1) change the warning label or disseminate additional warnings to reflect the alleged additional dangers associated with the “off-label” use of amiodarone for atrial fibrillation; 2) accept state tort liability; or 3) exit the market place. . . .  [S]uch a result requires preemption under Mensing and Bartlett.  Plaintiff’s “off-label” promotion claims, whether sounding in fraud or negligence, are preempted by the FDCA.

Id. at *5.

Also, as in Moore, the medication guide allegations were preempted as private FDCA enforcement under Buckman.  2017 WL 4348330, at *6-7.  Plaintiff didn’t even respond to Buckman, which the court found particularly “telling. Id.; see id. at *7 (“the requirement to provide a Medication Guide to distributors is based solely in the requirements of the FDCA and related regulations”).  The learned intermediary rule, which South Carolina follows, precluded any state-law liability for failing to provide warnings directly to a patient . Id. at *8.  Buckman also did in the off-label promotion claims, because the court found no state-law obligation to avoid off-label promotion.  “[T]he duties Plaintiff alleges Defendants breached regarding ‘off-label’ promotion exist solely under the FDCA.”  Id. at *7.

The court in Bean was particularly unhappy with both plaintiffs’ allegations and with her counsel.  The allegations were inherently inconsistent, because by alleging that the medication guide contained “adequate and sufficient” warnings, the plaintiff necessarily defeated her own allegations.  “Plaintiff does not allege that the prescribing physician did not receive the Medication Guide, was unaware of its contents, or the risk [the guide discussed].”  Id. at *8.  These allegations weren’t “plausible on [their] face” under TwIqbal, because the prescriber received “adequate” warnings.  Id.  As for counsel:

Plaintiff’s failure to respond to the learned intermediary argument is striking because Plaintiff’s counsel has been involved in several other amiodarone cases that were dismissed in part pursuant to the learned intermediary doctrine.

Id. at *7 n.4 (string citation omitted).  Thus, the plaintiff in Bean, unlike the plaintiff in Moore, didn’t deserve – and didn’t get – any chance  to replead.  Id. at *8.

One thing that Moore and Bean exemplify to us is how preemption principles cut across product lines.  As we’ve chronicled, much of the favorable law as to off-label promotion was developed in the context of PMA preemption.  Buckman, of course, was an implied preemption case involving a 510(k) medical device.  Both Moore and Bean employed this precedent to dismiss claims involving generic drugs.  In view of this cross-pollination of defense arguments in preemption cases, we offer one final opportunity for improvement.  As we blogged about at length here, there is an additional Mensing/Bartlett preemption argument whenever off-label warning claims are asserted.  Only the FDA can require warnings about off-label uses.

A specific warning relating to a use not provided for under the “Indications and Usage” section may be required by FDA in accordance with sections 201(n) and 502(a) of the act if the drug is commonly prescribed for a disease or condition and such usage is associated with a clinically significant risk or hazard.

21 C.F.R. §201.57(c)(6)(i) (emphasis added).  See also 21 C.F.R. §201.80(e).   Thus, regardless of anything else, a manufacturer cannot add or alter warnings related to off-label uses without first getting the go ahead from the FDA.  In and of itself, that requires preemption of off-label warning claims under Mensing/Bartlett.  For more details, see the other post.

A defense win anywhere helps defendants everywhere.  Keep winning.

For the second time in three years the Pennsylvania legislature has proven itself entirely unable to carry out its most basic function, which is to pass a budget – any budget – which is balanced and otherwise meets constitutional requirements.  Instead, it seems bent on distracting the public from its abject failures with empty gestures.

Thus, we saw in Law 360 the other day that the legislature has passed, and the governor has agreed to sign, “right to try” legislation.  As we’ve discussed before, right to try legislation purports to make it easier for terminally ill patients to obtain access to drugs (and other FDA-regulated products) that have not completed the FDA’s long and arduous approval process.  In fact, we have seen no evidence that such legislation has ever actually helped anyone.  State right to try legislation has been ineffective chiefly for three reasons:  (1) it is federally preempted by the FDA’s compassionate use program, (2) manufacturers are unlikely to opt into these purely voluntary programs because any adverse events involving what would be a very sick patient population would have to be reported to the FDA and thus could jeopardize eventual approval, and (3) the legislation does not adequately protect manufacturers from potential liability for allowing the use of unapproved drugs.  Why do we care?  Because we worry about terminally ill patients suing manufacturers to force them to provide investigational drugs, which has been unsuccessfully tried in the past, and might be tried again in the future.

Obviously, no state legislation can do anything about problems #1 or 2, because those are matters governed by federal law that would require a federal statute.  As for problem #3, states have immunized manufacturers from state-law liability to a greater or lesser extent, so what about Pennsylvania?

Here’s a link to the text (as amended) of the current bill, HB45.

While there’s a section devoted to “health care provider immunity” (§5(a)), the potential liability of the entities that actually manufacture the investigational drugs (and other products) in question is only addressed in the section (§6) involving “construction” of the statute. That section provides – with unnecessary verbosity removed for clarity:

Nothing in this act may be construed as creating a private cause of action against a manufacturer of an investigational drug, biological product or medical device . . . for any injury suffered by the eligible patient resulting from the investigational drug, biological product or medical device, as long as the manufacturer . . . acted in accordance with this act, except when the injury results from a failure to exercise reasonable care.

(Emphasis added).

Pathetic. Probably worse than nothing. This section says zilch about liability under existing common-law theories – only about “creating” a new “private cause of action.”  Nor does it even preclude a new, private statutory cause of action.  To the contrary, it allows one, only it must be based on negligence (“failure to exercise reasonable care”).  As we’ve pointed out before, negligence is already the existing basis for Pennsylvania product liability for prescription medical products. See, e.g., Hahn v. Richter, 673 A.2d 888, 889 (Pa. 1996) (another case Bexis worked on way back when).  Thus, the Pennsylvania Right To Try legislation provides no additional protection to participating manufacturers at all – even those who complied with the statute – instead it appears to allow an additional, redundant negligence-based private statutory cause of action.

That being the case, there is no incentive whatsoever for any FDA regulated manufacturer to participate in the putative Pennsylvania Right To Try program, and every reason for them to refrain from doing so.  Rather, it’s an empty gesture – intended to distract the public from the legislature’s inability to perform its most basic constitutional duties.

Once the Supreme Court’s decision in Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017), definitively determined that non-resident plaintiffs can’t go suing non-resident defendants anywhere they want, attention turned to one of the primary types of forum-shopping gamesmanship that plaintiffs used to trap defendants in their preferred venues.

St. Louis – and thus the Eastern District of Missouri – were one of the first battle grounds, and as we celebrated here, here, and here, a jurisdiction that had previously been almost impervious to attempts to combat fraudulent misjoinder seems to be coming around.  See Jinright v. Johnson & Johnson, Inc., 2017 WL 3731317, at *4-5 (E.D. Mo. Aug. 30, 2017); Covington v. Janssen Pharmaceuticals, Inc., 2017 WL 3433611, at *4-5 (E.D. Mo. Aug. 10, 2017); Turner v. Boehringer Ingelheim Pharma, Inc., 2017 WL 3310696, at *3 (E.D. Mo. Aug. 3, 2017); Jordan v. Bayer Corp., 2017 WL 3006993, at *4 (E.D. Mo. July 14, 2017); Siegfried v. Boehringer Ingelheim Pharmaceuticals, Inc., 2017 WL 2778107, at *4-5 (E.D. Mo. June 27, 2017).  So far every post-BMS removal of a misjoined, multi-plaintiff action in Missouri has followed the rationale discussed in our prior posts (and below), except for those with timing issues.

So that’s one “magnet jurisdiction” seemingly on the way towards at least some degree of redemption.

Another one is the Southern District of Illinois, home to Madison and St. Clair Counties. That one started out looking a lot more doubtful.  The first court to decide a post-BMS removal case had the attitude that nothing had changed.  The court elected to ignore BMS – not even deigning to discuss it, beyond mentioning the defendant’s reliance.  Rios v. Bayer Corp., 2017 WL 3600374, at *1 (S.D. Ill. Aug. 22, 2017).  Otherwise, it appeared that the Southern District was going to continue a status quo that had allowed it to keep its docket largely free of escapees from Madison and St. Clair, no matter what:

Plaintiff’s Complaint alleges that Defendants are citizens of [numerous states and foreign countries], and that some of the plaintiffs are also citizens of [the same states].  Thus, complete diversity does not exist on the face of the Complaint.  In their Notice of Removal, Defendants state that this Court nonetheless has diversity jurisdiction because the out-of-state Plaintiffs’ claims were either fraudulently joined or procedurally misjoined, and thus the non-diverse Plaintiffs’ citizenship should be ignored for purposes of determining jurisdiction.  But because it is clear from the face of the Complaint that diversity jurisdiction is lacking, the Court need not first determine the existence of personal jurisdiction, and once again opts not to do so in this case.

Id. at *2.

And so things stood until just recently, until another jurist in the district (one who wasn’t a former member of ATLA’s board of governors), former Chief Judge Herndon, decided that he couldn’t in good conscience say that BMS changed nothing.  In a series of seven Xarelto cases, Judge Herndon recognized that there could be no more jurisdictional business as usual in the Southern District after BMS.  See Berousee v. Janssen Research & Development, LLC, 2017 WL 4255075 (S.D. Ill. Sept. 26, 2017); Douthit v. Janssen Research & Development, LLC, 2017 WL 4224031 (S.D. Ill. Sept. 22, 2017); Braun v. Janssen Research & Development, LLC, 2017 WL 4224034 (S.D. Ill. Sept. 22, 2017); Bandy v. Janssen Research & Development, LLC, 2017 WL 4224035 (S.D. Ill. Sept. 22, 2017); Pirtle v. Janssen Research & Development, LLC, 2017 WL 4224036 (S.D. Ill. Sept. 22, 2017); Roland v. Janssen Research & Development, LLC, 2017 WL 4224037 (S.D. Ill. Sept. 22, 2017); and Woodall v. Janssen Research & Development, LLC, 2017 WL 4237924 (S.D. Ill. Sept. 22, 2017).

Since they are all by the same judge on the same subject, these seven opinions not surprisingly track the same rationale.  We’ll reference the most recent decision, Berousee, in our discussion. Berousee is a typical (actually somewhat on the small side, in our experience) misjoined mishmash of “32 non-Illinois plaintiffs from 18 different states who were embedded in the lawsuit explicitly to destroy diversity jurisdiction” by making sure that at least one plaintiff was not diverse from the non-resident defendant being sued.  Id., 2017 WL 4255075, at *1.  This motley crew of plaintiffs were blatantly misjoined, having nothing to do with one another, except allegedly taking the same product and suffering similar types of injuries

Notwithstanding the facial non-diversity of the complaint, the defendant removed (from St. Clair county), citing (“draw[ing] attention to”) BMS for the proposition that “state courts lack specific jurisdiction to entertain non-resident plaintiff claims.”  Id.  The court agreed that BMS “established the Fourteenth Amendment’s due process clause did not permit the exercise of specific personal jurisdiction in state court over nonresident consumer’s claims.”  Id. at *1 n.2.

The key point in all these cases is the federal district court’s “discretion in jurisdiction.”  That is, under Ruhrgas AG v. Marathon Oil Co., 526 U.S. 574 (1999), such courts, in determining their jurisdiction, are free to invert the usual process and consider personal jurisdiction before diving into subject matter jurisdiction where the personal jurisdiction question is “straightforward” and “present[s] no complex question of state law,” and conversely “subject-matter jurisdiction is problematic.”  Berousee, 2017 WL 4255075, at *2 (discussing Ruhrgas).

[D]istrict courts do not overstep Article III limits when declining jurisdiction of state-law claims on discretionary grounds without determining whether those claims fall within their pendent jurisdiction without deciding whether the parties present a case or controversy.  Where a straightforward personal jurisdiction issue presenting no complex question of state law is pending before the Court − and the dispute over subject-matter jurisdiction is problematic − the court does not abuse its discretion by turning directly to personal jurisdiction.

Id. at *2 (Ruhrgas quotations omitted).

Now – that is to say, after BMS – personal jurisdiction is much more “straightforward” than the subject matter jurisdictional thicket of fraudulent misjoinder and CAFA jurisdiction:

[S]everal courts [have] utilized the BMS holding [and] conclusively held personal jurisdiction − instead of subject-matter jurisdiction − is the more straightforward inquiry.  Based on the above recent legal decisions combined with lack of “unyielding jurisdictional hierarchy,” interests of judicial economy, and weight of the precautionary effect on ruling on an issue that could regress and bind the state court, the Court finds that in this matter personal jurisdiction is the more straightforward inquiry − and will analyze same before addressing challenges to subject-matter jurisdiction.

Id. at *3 (citations to E.D. Mo. decisions already cited in this post omitted).

That was the hard part, because once the court gets to the personal jurisdiction inquiry, application of BMS really is pretty cut and dried in the context of mass torts and multi-plaintiff misjoined complaints.  General personal jurisdiction was out under our old friend Daimler AG v. Bauman, 134 S. Ct. 746 (2014), as the defendant was neither incorporated nor headquartered in Illinois. Berousee, 2017 WL 4255075, at *3.

As for specific jurisdiction, “[i]n exercising specific personal jurisdiction, defendants’ contacts with Illinois must be directly related to the challenged conduct.”  Id. (citations omitted).  There must be “purposeful availment” related to litigation.  Id. at *3 n.3.  Plaintiffs claimed that “defendants purposefully targeted Illinois as the location for multiple clinical trials which formed the foundation for defendants’ [FDA new drug] application.”  Id. at *4.  That was insufficient under BMS:

It is undisputed that the non-Illinois plaintiffs do not claim injuries from ingesting [the drug] in Illinois, and all conduct giving rise to the non-Illinois plaintiffs’ claims occurred elsewhere. The instant matter is analogous to BMS where the United States Supreme Court held that California state courts do not retain specific personal jurisdiction over non-resident defendant pharmaceutical companies, for non-resident plaintiff claims not arising out of or relating to defendant’s contacts with California. . . .  [T]his Court lacks specific personal jurisdiction over defendants regarding the non-Illinois plaintiffs’ claims.

Id. (emphasis original).

The plaintiff-side jurisdictional argument that Berousee rejected was the same one allowed by an Illinois intermediate appellate court last year in M.M. v. GlaxoSmithKline LLC, 61 N.E.3d 1026 (Ill. App. 2016), which is why M.M. became our #8 worst case of the year.  While the Supreme Court recently denied certiorari, see 2017 WL 1153625 (U.S. Oct. 2, 2017), that means next to nothing.  Consider, for example, the number of denied certiorari petitions in PMA preemption cases before the Court took, and affirmed, the pro-preemption decision in Riegel.  Off the top of our heads (and it’s been a while) we can name at least four − Martin v. Medtronic; Brooks v. Howmedica; Kemp v. Medtronic (one of Bexis’); and Mitchell v. Collagen.  There are probably more.

So we wouldn’t read anything into the denial in M.M.  It’s reasoning didn’t impress us – at minimum it is another “grasping” and “exorbitant” theory of personal jurisdiction that, like those in Bauman and BMS, cannot pass Due Process muster.  More importantly, M.M. is questionable in light of the Illinois Supreme Court’s recent decision in Aspen American Insurance Co. v. Interstate Warehousing, Inc., 2017 WL 4173349 (Ill. Sept. 21, 2017), which not only decisively rejected jurisdiction by consent, id. at *4-5,  but also had this to say about a similar theory, involving warehouses rather than clinical trials:

[P]laintiff has established that defendant does business in Illinois through the warehouse. . . .  But this fact falls far short of showing that Illinois is a surrogate home for defendant.  Indeed, if the operation of the warehouse was sufficient, in itself, to establish general jurisdiction, then defendant would also be at home in all the other states where its warehouses are located. The Supreme Court has expressly rejected this reasoning.

Id. at *4.  Granted, Aspen Insurance was addressing general jurisdiction, but since we’re discussing non-resident plaintiffs and Due Process, the “grasping”/”exorbitant” principle is the same.  Substitute “clinical trials” for “warehouses” and you can see where this is going….

Nor, getting back to the focus of this post, did the clinical trials argument impress Judge Herndon.  He was so unimpressed, he didn’t even cite M.M. while rejecting its rationale.  In Berousee,“the non-Illinois plaintiffs failed to allege ingestion of [the drug] in Illinois, or suffered from injuries caused by [the drug] in Illinois.”  2017 WL 4255075, at *4.  Without such allegations, “there is no connection between Illinois and the underlying [drug] controversy, which in itself is unconnected to Illinois.”  Id.  Allegations like the plaintiffs, about clinical trials generally, merely involved “general connections with forum [that] are not enough; a corporation’s continuous activity of some sort within a state is not enough to support demand that corporation be amenable to lawsuits unrelated to specified activity.”  Id.  The same sort of conduct “took place throughout the United States.”  Id. at *4 n.4.  But the non-resident plaintiffs “were not prescribed [the drug] here, nor did they purchase the drug, suffer any injury, or receive treatment in [this state].”  Id.

There being no personal injury over non-resident plaintiffs’ claims against non-resident defendants, those plaintiffs had to be dismissed, without prejudice.  Id. at *4-5.  Dismissal of those plaintiffs’ claims meant that complete diversity existed between the lone Illinois plaintiff and the defendants, so remand of that claim to state court was denied.  Id. at *5.

The other six decisions by Judge Herndon apply the same core jurisdictional reasoning as Berousee almost verbatim.  See Douthit, 2017 WL 4224031, at *3-6; Braun, 2017 WL 4224034, at *3-6; Bandy, 2017 WL 4224035, at *3-6; Pirtle, 2017 WL 4224036, at *3-6; Roland, 2017 WL 4224037, at *2-5; Woodall, 2017 WL 4237924, at *3-6.

That is not to say that they are identical in all respects, however.  In Douthit, the plaintiffs’ back-up argument, that the removal was untimely, was rejected almost out of hand.  The Supreme Court’s decision in BMS constituted an “order or other paper” under 28 U.S.C. § 1446(b)(3) opening up a new 30-day removal period.  2017 WL 4224031, at *6.  Plaintiffs made only “a feeble attempt to persuade the Court that pleadings and orders filed in other suits, not related to the removed case” weren’t “orders or other papers” under this statute . Id.  The court decisively rejected this “erroneous[] conten[tion]”:

Correctly, defendants attest BMS conclusively established the Due Process Clause prohibits non-Illinois plaintiffs from filing claims against defendants in Illinois state courts.  The Court agrees with defendants and finds plaintiffs’ argument unfounded.  When a “different case resolve[s] a legal uncertainty concerning the existence of original federal jurisdiction[,]” removal is allowed on that basis.

Id. (quoting Wisconsin v. Amgen, Inc., 516 F.3d 530, 534 (7th Cir. 2008)). Accord Braun, 2017 WL 4224034, at *6; Bandy, 2017 WL 4224035, at *6; Pirtle, 2017 WL 4224036, at *6; Roland, 2017 WL 4224037, at *5; Woodall, 2017 WL 4237924, at *6.

We hope that Judge Herndon’s septilogy (while not as entertaining as J.K. Rowling’s) nails down post-BMS jurisdictional issues in Southern District of Illinois, just as firmly as those issues appear to be resolved in the Eastern District of Missouri.  On to California and Pennsylvania.

In our continuing quest to share worthwhile educational opportunities with our loyal readers, we have a double shameless plug this weekend.

First, some of your favorite Drug and Device Law bloggers will be presenting at Reed Smith’s Philadelphia Life Sciences CLE Day on Thursday, November 2 at Reed Smith’s Philadelphia office. This is a free, full-day CLE program designed for in-house counsel at life sciences companies.

Eric Alexander will be part of a panel discussing “Digital Health: Issues and Considerations with Patient Engagement, Connected Devices, and Integrated Data” and Bexis and Rachel Weil will be speaking on “Going Long: Addressing the Biggest Opportunities and Threats in Prescription Medical Product Liability Litigation.”

In between, some of our Reed Smith colleagues will discuss:

  • The False Claims Act post-Escobar
  • State AG trends/activities concerning the life sciences industry
  • The insurance implications of aggressive civil litigation by state and local governments against pharmaceutical companies and distributors
  • The jurisdiction and venue refresh provided by Bristol-Myers and TC Heartland
  • Trends and recent angles of attack in product liability jury trials
  • Lessons learned in international arbitration battles

The good people at Reed Smith are also providing a networking breakfast and lunch, with a reception immediately following the CLE day.

This is a free, full-day program presumptively approved for 7.2 CLE credits in New Jersey and 6 CLE credits in Pennsylvania (application for Delaware credit is pending; for lawyers licensed in New York, the day is eligible for 7 credits under New York’s Approved Jurisdiction Policy).

Interested? You can register here. (Please note that space is limited.)

Our second learning opportunity carries no such space restrictions. Bexis will be co-presenting a free (can’t beat free) Washington Legal Foundation webinar on “Personal Jurisdiction and Venue Disputes: Succeeding in a Changed Legal Environment” on October 11 at 1:00-2:00 pm EST, with Phil Goldberg of Shook, Hardy & Bacon.  Here’s a description of the topic (WLF wrote this, not me):

Previously relegated to law-school classroom debate, personal jurisdiction and venue are now front-of-mind issues for civil litigators.  Our speakers will address how lower courts, and the plaintiffs’ bar, have responded to the U.S. Supreme Court’s recent restrictions on forum shopping. They will also identify the open questions and possible loopholes in the new jurisprudence, and discuss strategic responses on how to obtain and keep a “home court” advantage.

RSVP: to glammi@wlf.org.  More information on the webinar, and instructions on how to register, are here.

With Bexis having originally conceived the preemption argument that became Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), we are always on the lookout for ways in which plaintiffs attempt to circumvent Buckman’s result and thus  to pursue private litigation over fraud on the FDA.

Plaintiffs love to claim fraud on the FDA. It’s their all-purpose response to any FDA action that they don’t like.  For over fifteen years, now, Buckman has severely cramped their style.

One group of plaintiffs thought they had found their way around Buckman – relators bring cases under a federal statute, the False Claims Act, 31 U.S.C. §3729 (“FCA”).  Since the FCA is a federal statute, the preemption rationale by which the FDCA, and specifically 21 U.S.C. §337(a), prohibiting private enforcement, bars conflicting state-law theories would not apply.  These plaintiffs thought they had reached the promised land.

Not so fast.

Actually, all they’d come up with were a few bits of legal trumpery. The Oxford Dictionary offers four definitions for trumpery:

  • “Attractive articles of little value or use.”
  • “Practices or beliefs that are superficially or visually appealing but have little real value or worth.”
  • “Showy but worthless.”
  • “Delusive or shallow.”

When the word fits, use it. All the definitions (the first two are nouns; the last two adjectives) fit here.

We saw the end coming, in this post, discussing United States ex rel. D’Agostino v. EV3, Inc., 153 F. Supp.3d 519 (D. Mass. 2015), and it has now drawn nigh.  First, D’Agostino was affirmed. D’Agostino v. ev3, Inc., 845 F.3d 1 (1st Cir. 2016).  We discussed that decision, with great glee, here.  Fraud on the FDA, unless the FDA actually found fraud, didn’t cut it under the FCA, because causation would be entirely speculative – plaintiffs would have to prove a counterfactual hypothesis, that the FDA would have done something other than what it in fact did:

If the representations did not actually cause the FDA to grant approval it otherwise would not have granted, [the government] would still have paid the claims.  In this respect, [relator’s] fraudulent inducement theory is like a kick shot in billiards where the cue ball “could have” but did not in fact bounce off the rail, much less hit the targeted ball.

Id. at 7.  Where the FDA didn’t act on an FCA plaintiff’s allegations, those claims are mere trumpery.  The materiality standard for FCA claims is tough – “[i]t is a ‘demanding’ standard.”  Id. (quoting Universal Health Services, Inc. v. United States, 136 S.Ct. 1989, 2003 (2016)).  If it’s not enough to impress the FDA directly under the FDCA, purported fraud on the FDA is certainly not enough to move the needle under the FCA.

D’Agostino was good, but a more recent case, United States ex rel. Nargol v. DePuy Orthopaedics, Inc., 865 F.3d 29 (1st Cir. 2017), is even better.  The allegations in Nargol were practically indistinguishable from what the Bone Screw plaintiffs alleged two decades ago in Buckman itself.  The plaintiff, a pair of doctors who “claim to be experts in hip-replacement techniques and devices,” id. at 31, claimed that the manufacturer of a such a device “made a series of false statements to the FDA . . ., but for which the FDA would not have approved the [product] or would have withdrawn that approval.”  Id. at 32.  Sounds like a broken record to us:

Plaintiffs say petitioner made fraudulent representations to the Food and Drug Administration (FDA or Administration) in the course of obtaining approval to market the [product]. . . .  Had the representations not been made, the FDA would not have approved the devices, and plaintiffs would not have been injured.

Buckman, 531 U.S. at 343.  This plaintiff-side trumpery also reminds us of an advertising “slogan” from the Onion.  The only difference between Nargol and Buckman were the purported damages – while Buckman invoked fraud on the FDA to allege that every use of the device in question was automatically a tort, Nargol pushed the same theme to claim that every such use (on Medicare and certain other patients) was automatically a false claim.

Talk about allegations “of little use or value.”

Focusing on the claims, “whether direct or indirect, that rest on the allegation that [defendant] misrepresented the safety and effectiveness of the product’s design in order to secure or maintain FDA approval,” the panel “appl[ied and extend[ed]” D’Agostino to affirm dismissal.  Id. at 31, 34.  Unlike D’Agostino, which had involved a PMA medical device, Nargol involved a device that had been cleared for marketing as “substantially equivalent” under so-called “§510(k) clearance.” Id. at 34.  That difference didn’t matter, since the claims in both cases sought to attack the integrity of the process by which the FDA allowed the products in question to be marketed.

The claim in this case is not quite on all fours with the claim we confronted in D’Agostino because the FDA does not independently assess the safety and effectiveness of a [510(k)] medical device. . . .

Nevertheless, the process constitutes the government’s method of determining whether a device is safe and effective as claimed.  That determination is what makes the product marketable, and Relators offer no suggestion that government reimbursement rules require government health insurance programs to rely less on section 510(k) approval than they do other forms of FDA approval.

Id. (emphasis added) (citations to Lohr and Buckman omitted).  We would be remiss if we failed to note that, in this respect Nargol is congruent with what the FDA itself said earlier this year – that, yes, the 510(k) process does involve determinations of device safety and effectiveness.  Lohr is anachronistic on this point, and will eventually be reconsidered.

But we digress.  Back to fraud on the FDA, where Buckman, by comparison, isn’t out-of-date at all.

The FDA, as Buckman observed, wields plenty of tools to protect itself from being defrauded and to punish anyone so bold as to try.  531 U.S. at 349 (listing administrative powers).  Its lack of exercise of such powers in Nargol demonstrates the trumpery nature of the plaintiffs’ claims:

The FDA, in turn, possesses a full array of tools for “detecting, deterring, and punishing false statements made during . . . approval processes.”  Its decision not to employ these tools in the wake of Relators’ allegations so as to withdraw or even suspend its approval of the . . . device leaves Relators with a break in the causal chain between the alleged misstatements and the payment of any false claim.

865 F.3d at 34 (emphasis added) (Buckman citation omitted).  For this reason, the FDA’s decision not to act “also renders a claim of materiality implausible.”  Id.

Even in an ordinary situation not involving a misrepresentation of regulatory compliance made directly to the agency paying a claim, when “the Government pays a particular claim in full despite its actual knowledge that certain requirements were violated, that is very strong evidence that those requirements are not material.”

Id. at 34-35 (quoting UHS, 136 S. Ct. at 2003).  Such evidence is not just “strong,” but “compelling” when “an agency armed with robust investigatory powers to protect public health and safety is told what Relators have to say, yet sees no reason to change its position.”  Id. at 35.

Thus, without an FDA finding that it was defrauded, fraud on the FDA allegations by FCA relators are both too speculative to plead causation plausibly and not material.  That’s not quite preemption but is satisfyingly close.  Fraud on the FDA allegations, without support from the FDA itself, amount to trumpery:

[T]here is no allegation that the FDA withdrew or even suspended product approval upon learning of the alleged misrepresentations.  To the contrary, the complaint alleges that Relators told the FDA about every aspect of the design of the . . . device that they felt was substandard, yet the FDA allowed the device to remain on the market. . . .  Such evidence does show that the FDA was paying attention.  But the lack of any further action also shows that the FDA viewed the information, including that furnished by Relators, differently than Relators do.

Id. at 35 (emphasis added).  Right.  The FDA considered these allegations to be fake news.

Plaintiffs had a fallback position – that even after the device was approved, its mere use could constitute a “false claim.”  To wit:  “In theory, a product may be sufficiently ‘safe’ and ‘effective’ to secure FDA approval for a given use, yet its use might nonetheless not be sufficiently ‘reasonable and necessary’ for patient care to warrant Medicare reimbursement.”  Id.  More trumpery, held Nargol.  The “complaint was devoid of particularized allegations,” the differences being claimed were within the “maximum failure rate provided under industry guidelines,” and ultimately “simply runs Relators back into” their fraud on the FDA claims.  Id. at 36.  Thus, no causation and no materiality:

We see no reason, though, why such a likely and customary repetition of the statements made to the FDA renders it more plausible that a materially false statement caused the payment of a claim that would not have been made otherwise.  The government, having heard what Relators had to say, was still paying claims . . . but because the government through the FDA affirmatively deemed the product safe and effective.

Id..  Yes, a 510(k) clearance means “the FDA affirmatively deemed the product safe and effective.”

Ultimately D’Agostino prevailed.  Plaintiffs “offer[ed] no rebuttal at all to D’Agostino’s observation that six jurors should not be able to overrule the FDA.”  Id.  Their arguments “offer[ed] no solution to the problems of proving that the FDA would have made a different approval decision in a situation where a fully informed FDA has not itself even hinted at doing anything.”  Id.

Between them, D’Agostino and Nargol should slam the door on plaintiffs’ attempt to assert fraud on the FDA under the guise of FCA claim (unless the FDA itself has reached the same conclusion).  See In re Plavix Marketing, Sales Practice & Products Liability Litigation (No. II), 2017 WL 2780744, at *21-23 (D.N.J. June 27, 2017) (rejecting similar FCA fraud on the FDA allegations against prescription drug).  Moreover, the emphasis in these cases on the speculative nature of attempting proof of what the FDA might have done if presented with a different set of facts also casts doubt on the Third Circuit’s terrible Fosamax decision, which, as we have pointed out, would saddle juries with the task of doing just that.

Your bloggers always do our best to alert our loyal readers to interesting, informative events. For those of you on the right side of the v and in the Greater Philadelphia area, the Drug & Device Defense Forum definitely makes the list.

This is a defense-only program for litigators and in-house counsel, and it counts the blog’s own Michelle Hart Yeary as one of its co-chairs, so you know it’s a quality program. Several of your bloggers have spoken at the event in the past, and Bexis will be doing so this year as part of a panel on “Emerging Issues in Drug and Device Litigation & Regulation.”

For more information, or to register, you can visit the event website.

We’re quite familiar with people who say one thing, when they think that’s in their interest, and later when circumstances change, say something quite different.  For example, as the late, great Molly Ivins pointed out in “Molly Ivins Can’t Say That, Can She?”,  back during the energy crisis of the mid-to-late 1970s, folks down in Texas “did put bumper stickers on their pickups . . . that said, ‘Let the Yankee Bastards Freeze in the Dark.’” Id. at 43.  As others have pointed out, Hurricane Sandy brought out similar sentiments.  These days, not so much….

But what about in prescription medical product liability litigation?  Say, for example, one of our defense colleagues absolutely nailed it at a deposition.  The result is rock-solid deposition testimony that the prescribing physician never read that allegedly inadequate warning.  Or else it’s the plaintiff admitting that s/he only took the version of the drug manufactured by a different company.  Summary judgment should be a lock. . . .

The motion is filed. The plaintiff’s response, however, includes an affidavit from the same witness already deposed at length – and the affidavit directly contradicts the witness’ prior testimony on which the motion was based.  Plaintiff claims that, now, at minimum, the contradictory testimony creates a “fact issue” and the “credibility” of the two irreconcilable versions of for the jury to decide.

What now?

First of all, it’s happened before – many times.   Almost 20 years ago, the United States Supreme Court addressed the same situation where a plaintiff, having filed for disability (requiring her to swear she was “totally disabled”), and then later filed an age discrimination suit (the matter before the Court), in which she had to prove she was a “qualified person.”  Cleveland v. Policy Management Systems Corp., 526 U.S. 795, 805-06 (1999).  Plaintiffs, the Court held, “cannot simply ignore the apparent contradiction that arises” from taking apparently irreconcilable positions.  Instead, they “must proffer a sufficient explanation” of such discrepancies.  Id. at 806.  The Court endorsed the analogous doctrine that:

[A] party cannot create a genuine issue of fact sufficient to survive summary judgment simply by contradicting his or her own previous sworn statement (by, say, filing a later affidavit that flatly contradicts that party’s earlier sworn deposition) without explaining the contradiction or attempting to resolve the disparity.

Id. (string citation omitted).  See generally, e.g., Perma Research & Development Co. v. Singer Co., 410 F.2d 572, 578 (2d Cir.1969) (generally viewed as the seminal case on sham affidavits) (applying New York law); Shelcusky v. Garjulio, 797 A.2d 138, 144-45 (N.J. 2002) (excellent general citator for sham affidavit decisions).

Enter the sham affidavit doctrine (sometimes elevated to the status of a “rule”), now with Supreme Court imprimatur, precluding creation of “genuine” factual issues by a plaintiff (or some other essential witness) simply contradicting his or her own previous sworn testimony.  The oldest decision we’ve found applying the sham affidavit doctrine in a prescription medical product liability litigation is Miller v. A.H. Robins Co., 766 F.2d 1102 (7th Cir. 1985) (applying Indiana law), where the plaintiff, after testifying that several of her treaters told her that her injuries were caused by the product, submitted an affidavit denying everything once hit with a summary judgment motion raising the statute of limitations.  As one of the opinions that created the sham affidavit doctrine, Miller began with the proposition that “[p]arties cannot thwart the purpose of Rule 56 by creating issues of fact through affidavits that contradict their own depositions.”  Id. at 1104.  The plaintiff was not “confused” while testifying, and “made no corrections to her statements” when the transcript of her deposition was made available.  Id. at 1105.  “Consequently this affidavit did not create a genuine issue of fact and the district court could grant summary judgment.”  Id.

In another relatively old decision – pre-Cleveland, so the sham affidavit doctrine did not yet have the Supreme Court’s endorsement − a plaintiff-affiliated fact witness (the plaintiff’s mother) had her testimony excluded in Martin v. Merrell Dow Pharmaceuticals, Inc., 851 F.2d 703 (3d Cir. 1988) (applying Pennsylvania law, we think).  The witness tried to change her testimony about when she ingested a purportedly teratogenic drug.  The sham affidavit doctrine stopped this attempt:

The numerous other courts of appeals that have considered the situation in which a party contradicts, without satisfactory explanation, his or her prior testimony, have reached the same decision.  Each court has concluded that the objectives of summary judgment would be seriously impaired if the district court were not free to disregard the conflicting affidavit.

Id. at 706 (citations omitted).  “When, as in the present case, the affiant was carefully questioned on the issue, had access to the relevant information at that time, and provided no satisfactory explanation for the later contradiction, the courts of appeals are in agreement that the subsequent affidavit does not create a genuine issue of material fact.”  Id.

According to Westlaw, 128 cases cite Martin for this proposition, but as far as we can tell, only one of those involved prescription medical product liability litigation.  The exception is Rohrbough. Wyeth Laboratories, Inc., 719 F. Supp. 470 (N.D.W. Va. 1989), aff’d, 916 F.2d 970 (4th Cir. 1990), where the court entered summary judgment after excluding an expert witness’ medical causation affidavit because it contradicted prior sworn deposition testimony.  “[I]f a statement in an affidavit that contradicts earlier deposition testimony constitutes an attempt by the nonmoving party to create a sham issue of fact, it may be disregarded.”  Id. at 474. Miller was cited as Seventh Circuit precedent, along with pre-Cleveland decisions from eight circuits (with only one circuit going the other way).  Id.  In stark contrast to the expert’s deposition testimony, which “reveal[ed] a cautious, circumlocutory doctor,” the contrary affidavit was “concise” and “unhesitant.”   “[T]here is no explanation in the affidavit for why [the expert] is suddenly so willing to offer his unqualified opinion . . . when he had earlier only been willing to defer to experts in the relevant field in his deposition.”  Id. at 475.  On appeal, the Fourth Circuit affirmed, also invoking the sham affidavit doctrine:

Given the conflicts between [the expert’s] affidavit and his deposition testimony, the district court was left not with a genuine issue of material fact, but with trying to determine which of several conflicting versions of [the expert’s] testimony was correct.  We hold that the district court was justified in disregarding the affidavit.  We agree with the district court that it may not represent the considered opinion of the doctor himself, but rather an effort on the part of the plaintiffs to create an issue of fact.

Rohrbough v. Wyeth Laboratories, Inc., 916 F.2d 970, 976 (4th Cir. 1990) (citation omitted) (applying West Virginia law).

On the blog, we’ve previously discussed several cases that involved the sham affidavit doctrine, but we’ve never reviewed it more comprehensively.  Most recently, in Redd v. DePuy Orthopedics, Inc., ___ F. Appx. ___, 2017 WL 2859536 (8th Cir. June 6, 2017) (applying Missouri law), the plaintiff’s marginally qualified (if that) design expert changed his tune in an affidavit “submitted after [defendant] moved for summary judgment.”  Id. at *2.  Recognizing that “[a] party may not avoid summary judgment by submitting an affidavit that contradicts rather than clarifies previous sworn testimony,” the court of appeals examined several issues on which the expert’s affidavit changed his testimony.  Id.

Given such differences between the testimony [the expert] provided during discovery and his affidavit, we conclude that the district court did not abuse its discretion by excluding the affidavit from consideration at summary judgment.

Id.  The standard of review is important in sham affidavit cases – exclusion of evidence is governed by abuse of discretion.

Another recent appellate decision reaching the same result is In re Avandia Marketing, Sales Practices & Products Liability Litigation, 639 F. Appx. 874 (3d Cir. 2016) (applying Pennsylvania law), only this time the plaintiff had suborned her prescribing physician to recant his prior testimony under oath.  In deposition, the prescriber had “testified that even if [defendant]  had warned of the risks . . . associated with [the drug], he would still have prescribed the drug to [plaintiff].”  Id. at 876.  After the defendant sought summary judgment, plaintiff offered the prescriber’s affidavit stating that with “a different and more thorough warning . . . he never would have prescribed the drug.”  Id. at 876 n.3.  The district court, and then the Third Circuit, were having none of it.  Again, “[i]t was also within the District Court’s discretion to strike . . . the [prescriber’s] Affidavit, which contradicted [his] deposition testimony.”  Id. at 877.  “This Court defines a ‘sham affidavit’ as a contradictory affidavit that indicates only that the affiant cannot maintain a consistent story or is willing to offer a statement solely for the purpose of defeating summary judgment.  Id. at 877 n.5 (citation and quotation marks omitted).

When a deponent’s post-deposition affidavit conflicts with his prior testimony, a district court may disregard the affidavit to prevent a party from creating a material issue of fact to defeat summary judgment by filing an affidavit disputing his or her own sworn testimony without demonstrating a plausible explanation for the conflict.  A district court may strike such an affidavit based upon the timing of the affidavit, whether any other record evidence supports the affidavit, and whether there is a plausible explanation for the contradiction.  Each of these considerations supports striking the [prescriber’s] Affidavit.

Id. at 877 (footnote, citations and quotation marks omitted).  Needless to say, exclusion of the sham affidavit and summary judgment on causation grounds was affirmed.  Id. at 879.

Ditto in In re Fosamax Products Liability Litigation, 707 F.3d 189 (2d Cir. 2013) (applying Florida law), where yet again the plaintiff induced her prescribing physician to change his deposition testimony and offer conflicting “expert” testimony on causation-related issues “central to [plaintiff’s] failure-to-warn claim” in a subsequent deposition taken after summary judgment was filed.  Id. at 195.  This stratagem was unsuccessful, as the Second Circuit held that the sham affidavit doctrine was nonetheless applicable to preclude plaintiff from relying on the witnesses second, “diametrically different story” in another deposition:

[W]e hold that the District Court was entitled to disregard [this] new testimony relating to his knowledge based on the “sham issue of fact” doctrine, which prohibits a party from defeating summary judgment simply by submitting an affidavit that contradicts the party’s previous sworn testimony.  Although we have typically applied the sham issue of fact doctrine where a party submits an affidavit that contradicts the party’s own prior statements, it may also apply when a party attempts to use evidence from an expert witness to defeat summary judgment.  In particular, the doctrine applies to stop [plaintiff] from manufacturing a factual dispute by submitting testimony from an expert whom she tendered, where the relevant contradictions between the first and second depositions are unequivocal and inescapable, unexplained, arose after the motion for summary judgment was filed, and are central to the claim at issue. . . .  We cannot reconcile his new testimony with his prior testimony.

Id. at 194 (citations and footnote omitted).  See Hickman v. Laboratory Corp., 460 F. Supp.2d 693, 699 (W.D. Va. 2006) (sham affidavit doctrine applied to treating physician’s “affidavit, which was filed only three days prior to the Motion for Summary Judgment hearing, was simply an attempt to add information that [he] failed to provide in his sworn deposition”).

In Ralston v. Smith & Nephew Richards, Inc., 275 F.3d 965, 973 (10th Cir. 2001) (applying Kansas law), the plaintiff’s expert changed his testimony in an attempt to support the sole remaining warning-related cause of action, after having given different testimony when the case seemed focused on design-related issues.  The subsequent “declarations” were disregarded as attempts to create “sham facts”:

[C]ourts will disregard a contrary affidavit when they conclude that it constitutes an attempt to create a sham fact issue. . . .  [Under] the[] circumstances, it is not an abuse of discretion to conclude − as the district court did − that these subsequent affidavits, which directly contradicted certain positions previously taken by [plaintiff’s expert] and which were detrimental to [plaintiff’s] sole remaining cause of action, constituted those kinds of affidavits which fall within the ambit of creating a “sham fact issue.”   Consequently, the district court was entitled to rely on [his] deposition testimony without regard to his later declarations in rendering its summary judgment ruling.

Id. at 973-74.

Another plaintiff expert bit the dust in Kline v. Zimmer Holdings, 2015 WL 4077495 (W.D. Pa. July 6, 2015), a case we discussed here.  Essentially, the expert bailed in her deposition on design defect opinions, and then later tried to resuscitate design issues in an affidavit filed in response to the defendant’s summary judgment motion.  Id. at *4.  After “consistently, carefully, and clearly set forth her opinion that the product, as designed, was not defective” at the deposition,” her contrary “affidavit cannot be considered” to “proffer expert testimony about the design defect claim.” Id.

It is appropriate to disregard her affidavit pursuant to the sham affidavit doctrine.  “A sham affidavit is a contradictory affidavit that indicates only that the affiant cannot maintain a consistent story or is willing to offer a statement solely for the purpose of defeating summary judgment.”  “[I]f it is clear that an affidavit is offered solely for the purpose of defeating summary judgment, it is proper for the trial judge to conclude that no reasonable jury could accord that affidavit evidentiary weight and that summary judgment is appropriate.”

Id. (quoting and following Jiminez v. All American Rathskeller, Inc., 503 F.3d 247, 253 (3d Cir.2007)).  See also Id. at *20 (magistrate’s opinion on same issue).

Still another plaintiff expert, after admitting that there was “no alternative” to the plaintiff undergoing certain medical procedure in his deposition, then tried to deny that same fact after the defendant sought summary judgment.   Zimmerman v. Novartis Pharmaceuticals Corp., 287 F.R.D. 357, 362 (D. Md. 2012) (discussed here).  Following Cleveland, the court invoked the sham affidavit doctrine and held that the “belatedly submitted new affidavit, being flatly contradictory to [the expert’s] deposition testimony, will not be considered.”  Id.

In state court, we encountered the same principle in In re Zoloft Litigation, 2016 WL 5958372 (W. Va. Cir. Oct. 5, 2016), again involving shenanigans by a plaintiff expert.  After being essentially destroyed in deposition, the expert signed an affidavit attempting to repair the damage.  After “not identify[ing] any means by which he was able to exclude other likely causal factors” in his deposition, in his affidavit, the expert professed “that he has excluded all causes other than [the drug].”  Id. at *7-8.  West Virginia’s version of the sham affidavit doctrine asks three questions:

(1) Whether the deposition afforded the opportunity for direct and cross-examination of the witness; (2) whether the witness had access to pertinent evidence or information prior to or at the time of his or her deposition, or whether the affidavit was based upon newly discovered evidence not known or available at the time of the deposition; and (3) whether the earlier deposition testimony reflects confusion, lack of recollection or other legitimate lack of clarity that the affidavit justifiably attempts to explain.

Id. at *8 (quoting Kiser v. Caudill, 599 S.E.2d 826, 828 (W. Va. 2004)).  Answering all these questions “yes,” finding that, since the expert “fail[ed] to offer any explanation for the inconsistency between his deposition testimony and his affidavit,” the affidavit therefore “failed to cure the admissions made during his deposition.”  Id. at *9.  As we discussed at greater length in the other post, exclusion required summary judgment.  Id. at at *10. See also Tortorelli v. Mercy Health Center, Inc., 242 P.3d 549, 561 (Okla. App. 2010) (plaintiff’s expert’s affidavit “directly contradicting prior deposition testimony” on standard of care issues disregarded); Dickenson v. EBI, LLC, 2009 WL 10672211, at *3 (W.D. Mo. July 30, 2009) (affidavit by plaintiff’s expert on design defect disregarded as sham).

Plaintiffs do it too – a lot.  They were caught twice in 2015, in Sparks v. Oxy-Health, LLC, 134 F. Supp.3d 961 (E.D.N.C. 2015), and Muzichuck v. Forest Laboratories, Inc., 2015 WL 235226 (N.D.W. Va. Jan. 16, 2015).  In Sparks the plaintiff unsuccessfully attempted to improve upon deposition testimony involving reliance:

Plaintiff[‘s] affidavit will be struck.  The affidavit provides a number of cursory statements that . . . [she] relied on certain misrepresentations at the time she purchased the [product].  However, at her . . . deposition, plaintiff . . . stated that she relied on her conversations with [a third party] . . . and the tangible benefits [of the product]. . . .  Defense counsel pointedly asked plaintiff if she relied on anything else.  She replied “no.”  There is a “bona fide inconsistency” between the two versions of plaintiff’s testimony.  The affidavit is a sham and accordingly is struck from the record.

134 F. Supp.3d at 998-99.

In Muzichuck, the plaintiff in a wrongful death action admitted in her deposition that the decedent had actually read the product’s package insert.  2015 WL 235226, at *12.  When that admission came back to haunt her, she swore out a contrary “declaration” denying that precise fact.  Id.  The court said, “No way, Jose”:

This attempt by [plaintiff] to create a contested issue of fact by disputing her own earlier deposition testimony is unconvincing. . . .  [She] cannot create a dispute about a fact that is contained in deposition testimony by referring to a subsequent affidavit or declaration of the deponent contradicting the deponent’s prior testimony, for it is well established that a genuine issue of fact is not created where the only issue of fact is to determine which of the two conflicting versions of a party’s testimony is correct.  Therefore, the Court concludes that there is no material question of fact in dispute.

Id. (quoting In re Family Dollar FLSA Litigation, 637 F.3d 508, 512 (4th Cir. 2011)).  For other instances of subsequent statements by plaintiffs being excluded under the sham affidavit rule in prescription medical product liability litigation, see Joseph v. Costco Wholesale Corp., 2015 WL 12745803, at *6 (C.D. Cal. Aug. 27, 2015) (“conclusory, self-serving declaration” regarding reading drug label at time of purchase excluded); Finnicum v. Actavis-Elizabeth, L.L.C., 2011 WL 13193350, at *5-6 (E.D. Tex. Jan. 6, 2011) (affidavit concerning causation knowledge disregarded; controlling law “does not allow a party to defeat a motion for summary judgment using an affidavit that impeaches, without explanation, sworn testimony”); Vitolo v. Mentor H/S, Inc., 426 F. Supp.2d 28, 37 (E.D.N.Y. 2006) (contradictory affidavit about importance of certain manufacturer representations about medical device held a sham), aff’d, 213 F. Appx. 16 (2d Cir. 2007); Reetz v. Jackson, 176 F.R.D. 412, 414-15 (D.D.C. 1997) (contradictory affidavit denying knowledge of FDA held a sham in Bone Screw case); In re A.H. Robins Co., 197 B.R. 495, 498 (E.D. Va. 1995) (excluding, for “egregious inconsistency” affidavit regarding product identification in bankruptcy proceeding); Gehring v. Showa Denko, K.K., 1994 WL 597584, at *3 (E.D. Pa. Nov. 2, 1994) (contradictory product identification affidavit held a sham); Baker v. A.H. Robins Co., 613 F. Supp. 994, 996 n.3 (D.D.C. 1985) (contradictory plaintiff knowledge affidavit not considered).

There are literally hundreds of sham affidavit decisions out there, but nowhere else, to our knowledge, have those only involving prescription medical product liability litigation been collected. Until now.

Several of your Reed Smith bloggers are busily making travel plans to be in New York December 4-6th. Are we planning major holiday shopping sprees? Are we off to do some picturesque ice skating around a large tree? Did we finally score Hamilton tickets?

Even better: We’re heading to ACI’s Drug and Medical Device Litigation conference, one of those rare “can’t miss” industry events that consistently provides great content and great networking opportunities – including the chance to catch up with our loyal readers.

(Bexis will be in his usual front and center seat if you want to chat. Eric Alexander will be presenting on a panel on the opioid crisis, the latest developments in the litigation, and enforcement trends. Others in our blogging lineup plan to be running in and out of sessions as well.)

Since we hope to see you at ACI, we wanted to share two pieces of helpful news:

  • First, the early bird discount for ACI ends this Friday, making this week an excellent one in which to register if you haven’t already.
  • Second, the good people at ACI asked the blog to be a media sponsor this year – and are offering a special registration discount for the conference for the blog’s readers. Make sure to use the code D10-999-DD18 when you register. You’ll save 10 percent.

If you want to register, you can do so here. We’ll look forward to seeing you in New York!

 

Back in 2013, Ramirez v. Medtronic Inc., 961 F. Supp.2d 977 (D. Ariz. 2013), made it to #9 on our worst cases of the year list – which is pretty good (actually, pretty bad) for a trial court decision.  Purporting to apply Stengel v. Medtronic Inc., 704 F.3d 1224, 1228-31 (9th Cir. 2013) (en banc) – an even worse case (#2 on the same list) – Ramirez held, basically, that allegations of off-label use/promotion eliminated preemption altogether, even for Class III pre-market approved products.

When the device is not being used in the manner the FDA pre-approved and the manufacturer is actually promoting such use, there is no law or policy basis on which to pre-empt the application of state law designed to provide that protection.

Id. at 991.

Fortunately, Ramirez has proven to be an outlier, with numerous decisions, several even in the same District of Arizona, considering and rejecting Ramirez’s meat axe approach to preemption.  See Angeles v. Medtronic, Inc., 863 N.W.2d 404, 413 (Minn. App. 2015) (“Ramirez has been rejected by most federal district courts that have reviewed this issue”); Coleman v. Medtronic, Inc., 167 Cal. Rptr.3d 300, 314 (App. 2014) (“[w]e find the approach taken in Ramirez unpersuasive”), app. dismissed & opinion ordered published, 331 P.3d 178 (Cal. 2014); McCormick v. Medtronic, Inc., 101 A.3d 467, 486 n.13 (Md. App. 2014) (“Ramirez has been almost universally rejected”); Shuker v. Smith & Nephew PLC, 211 F. Supp.3d 695, 701 n.5 (E.D. Pa. 2016) (“this Court considered but declined to follow” Ramirez); Jones v. Medtronic, 89 F. Supp.3d 1035, 1051 (D. Ariz. 2015) (“this Court joins the majority of courts in rejecting Ramirez”); Thorn v. Medtronic Sofamor Danek, USA, Inc., 81 F. Supp.3d 619, 627 (W.D. Mich. 2015) (Ramirez “has been rejected by numerous district courts”); Wright v. Medtronic, Inc., 81 F. Supp.3d 600, 610-11 (W.D. Mich. 2015) (same as Thorn); Byrnes v. Small, 60 F. Supp.3d 1289, 1299 (M.D. Fla. 2015) (“the Court disagrees with the reasoning in Ramirez”); Shuker v. Smith & Nephew PLC, 2015 WL 1475368, at *10 (E.D. Pa. March 31, 2015) (“the Ramirez decision has been widely criticized by other district courts reviewing allegations of off-label promotion of PMA-approved devices”); Arvizu v. Medtronic Inc., 41 F. Supp.3d 783, 790. Ariz. 2014) (“the Court finds the reasoning of [decisions rejecting Ramirez] to be more persuasive”); Martin v. Medtronic, Inc., 32 F.Supp.3d 1026, 1036 (D. Ariz. 2014) (“join[ing] the majority of other courts which have rejected Ramirez to the extent that it holds that the preemption analysis does not apply to claims based on off-label promotion”); Beavers-Gabriel v. Medtronic, Inc., 15 F.Supp.3d 1021, 1035 (D. Haw. 2014) (“however, Ramirez has been rejected − for good reason − by numerous courts”); Schouest v. Medtronic, Inc., 13 F. Supp.3d 692, 700 (S.D. Tex. 2014) (Ramirez “read Riegel too narrowly”); Scovil v. Medtronic, Inc., 995 F.Supp.2d 1082, 1096, n.12 (D. Ariz. 2014) (“respectfully disagree[ing] with [the] ruling in Ramirez”); Arthur v. Medtronic, Inc., 2014 WL 3894365, at *5 (E.D. Mo. Aug. 11, 2014) (Ramirez’s “reasoning has been rejected by several courts”); Brady v. Medtronic, Inc., 2014 WL 1377830, at *4 (S.D. Fla. April 8, 2014) (applying “the traditional preemption analysis to [plaintiff’s] off-label marketing claims” contrary to Ramirez); Houston v. Medtronic, Inc., 2014 WL 1364455, at *5 (C.D. Cal. April 2, 2014) (“the Ramirez holding is not consistent with the text of §360k(a), the scope of federal requirements imposed on Class III devices, or Ninth Circuit precedent”); Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 2013 WL 12149265, at *4 (N.D. Ala. Oct. 31, 2013) (Ramirez is “inapposite” and “of no assistance” to plaintiff).

Now the FDA has jumped into the fray, and its view of preemption and allegations of off-label use is no more favorable to Ramirez – and to plaintiffs trying to oust preemption of PMA devices – than these judicial decisions.  The sharpest-eyed of our readers may have noticed the two citations above to relatively recent district court opinions in a case called Shuker.  It so happens that Shuker is currently on appeal, and following oral argument, the Third Circuit Court of Appeals invited the FDA to provide its views on the preemption question.  Last week, the FDA did so.  You can find a copy of the FDA’s amicus brief in Shuker here.

Apparently, in Shuker the plaintiffs allege that the defendant was somehow responsible for Mr. Shuker’s surgeon creating a hybrid hip prosthesis construct that included some components of a Class III PMA system and others belonging to a Class II system cleared under the FDA’s “substantial equivalence” (“§510k”) process.  FDA amicus br. at 3-4.  This hybrid construct was an off-label use.  Id. at 4.  Exactly how the individual Class III and Class II component used in the construct are alleged to have contributed to the plaintiffs’ injuries appears totally unclear, but we do know that the Class III component was later recalled.  Id.

That causes the plaintiffs a big problem. On the one hand, they would love to smear the defendant with the recall, and wave it around like a bloody shirt.  On the other hand, the Class III component – because it was PMA approved – brings the powerful preemption defense into play.  So plaintiffs invoked off-label use to try to have their cake and eat it too.

The FDA did not agree.

Rather, the agency advised that “[t]he district court correctly held that §360k(a) applies to a component of a premarket-approved device even when the component is put to an unapproved use.”  Id. at 6.  First, the FDA clarified the status of device “components” under the FDCA::

The component of the premarket-approved device is itself a “device” under the FDCA, and FDA’s approval imposes device-specific requirements with respect to that component.  The manufacturer generally may not deviate from those requirements without prior approval from FDA, regardless of the uses to which the component may be put by third parties.  Because the component is subject to device-specific federal requirements, §360k(a) expressly preempts any state requirements “with respect to” the component that are “different from, or in addition to,” those device-specific federal requirements.

Id. (emphasis added).  Thus, all components of a pre-market approved device system are themselves PMA devices for preemption purposes, and that status doesn’t change because of off-label use.

With respect to other components, if they are “not subject to device-specific federal requirements,” then they are “outside the scope of §360k(a),” and claims limited to them “are not expressly preempted.”  Id.  To the extent those components are §510k cleared, they “generally” (but apparently not necessarily always) not entitled to preemption.  Id. at 7.

The fact that off-label use (which the FDA calls “unapproved use” in its letter) is possible for a device does not allow – let alone allow the common law to require – a manufacturer of a PMA device to change its design or labeling (read: warnings) or manufacturing processes without prior FDA approval:

As a general matter, the device-specific requirements that attach to a medical device through premarket approval apply even when the device is put to an unapproved use.  Once a device receives premarket approval, the FDCA generally prohibits the manufacturer from making, without FDA permission, changes that would affect the safety or effectiveness of the device. . . .  Those requirements apply irrespective of the use to which the device is ultimately put.  The possibility that a physician may choose to use a device for an unapproved purpose − something the FDCA contemplates, see 21 U.S.C. §396 − does not authorize a manufacturer to vary the design, the manufacture, or (with limited exceptions) the labeling of the device in anticipation of that use.  Such variation would violate federal law.

Id. (emphasis added).  Thus, the general rule that alterations that significantly affect a device’s “safety or effectiveness” require FDA preapproval exists “irrespective” of off-label use.

The FDA observed that “most” courts recognize that PMA imposes “requirements” – and therefore preemption – on medical devices “even when the device is put to an unapproved [off-label] use.”  Id. at 7-8 (citations omitted).  The agency also recognized something this Blog has repeatedly pointed out, that Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), the case in which the United States Supreme Court recognized broad PMA preemption, itself involved an off-label use.  FDA amicus br. at 8 (“Riegel itself involved an off-label use of the device in question”).  The FDA advised that, “[s]imply put, once a device receives premarket approval, it remains subject to federal requirements for purposes of §360k(a) regardless of how it is used.”  Id.

Nor did it matter that the off-label use was only of a “component” rather than of an entire device system. The PMA “requirements” applicable to that component as a “device” “apply equally when third parties put the [component] to an unapproved use with components of another device” even if the other device is §510(k) cleared. Id.

Defendants generally may not deviate from the requirements imposed through premarket approval regardless of how the liner is used.  Claims touching on those requirements therefore implicate §360k(a) even when a component of an approved device is put to the type of unapproved use here at issue.

Id.

Preemption of such claims is not only the law, but is good policy:

The conclusion that §360k(a) applies in this context also makes sense as a matter of policy.  Congress entrusted FDA with determining which device designs should be approved for marketing, as well as how approved devices should be labeled to provide medical professionals with appropriate safety information.  Section 360k(a) acknowledges FDA’s judgment in this respect and prevents States from pursuing competing judgments that would impose different or additional requirements on approved devices.  That provision also protects manufacturers that have complied with detailed federal requirements from being subjected to liability under state law for doing what federal law required.  Manufacturers must generally adhere to the specifications established through premarket approval, even if healthcare practitioners subsequently exercise their judgment and employ the device for an unapproved use.

Id. at 9 (emphasis added).  The FDA recognized the precedent cited at the beginning of this post – those cases criticizing Ramirez – as being “consistent” with the Agency’s preemption analysis.  Id.

Thus, the FDA advised that plaintiffs can’t go after the recalled PMA component, but are limited to claims concerning the non-PMA components of the construct only.  Id. at 10 (“§360k(a) requires a court to parse a plaintiff’s claims to determine whether the state-law requirements that underlie them are indeed directed at the premarket-approved component”).  “[A] component that did not receive premarket approval and is not otherwise subject to device-specific federal requirements” is not subject to express preemption under §360k(a).  The FDA “t[oo]k[] no position” on whether such claims were actually alleged, although they conceivably could be.  Id. at 12.

As for implied preemption, the FDA noted that “defendants did not raise implied preemption in their dispositive motions below, nor . . . in their original appellate briefing.” FDA amicus br. at 13.  Assuming that implied preemption was nonetheless at issue, the Agency confirmed:

[T]he existence of an express-preemption provision such as §360k(a) does not ordinarily alter the normal operation of implied-preemption principles.  Accordingly, state-law medical-device claims that are not expressly preempted remain subject to challenge on implied preemption grounds

Id. (citing Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 352 (2001)).

The FDA then briefly explored what many courts (but not the FDA) have called the “narrow gap” between express and implied preemption in PMA cases.  Implied preemption impacts two types of claims that are not expressly preempted:  (1) “parallel” claims; and (2) claims concerning “generally applicable federal requirements that do not trigger the operation of §360(k).”  FDA amicus br. at 14.  Purportedly parallel claims are preempted when they “have features that intrude impermissibly on the operation or enforcement of the FDCA, as where they represent an attempt to enforce the federal scheme, rather than asserting independent state-law requirements.”  Id.  As for “generally applicable” claims, “on a case-by-case basis,” “divergent state requirements may stand as an obstacle to the operation or objectives of the federal scheme and may be impliedly preempted on that basis.”  Id.  The FDA did not get any more specific than that as to implied preemption, noting instead that failure to report claims had been dismissed as inadequately pleaded, and therefore avoiding that issue.  Id. at 14 n.7.

What takeaways can we, as defense counsel, extract from the FDA’s filing? How about these:

  • Ramirez was wrongly decided. Off-label use does not affect the applicability of preemption at all. FDA amicus br. at 6-9.
  • PMA preemption applies to PMA components – period.  Id. at 7-10.
  • “[T]he FDCA generally prohibits the manufacturer from making, without FDA permission, changes that would affect the safety or effectiveness of the device.”  Id. at 7. That should help with Mensing/Bartlett preemption.
  • Implied preemption operates independently of express preemption, so that manufacturers of devices not subject express preemption under §360k(a) can still assert implied preemption “on a case-by-case basis.”  Id. at 14.  Also good for Mensing/Bartlett, particularly in the device context.
  • Ostensibly “parallel” claims are preempted where they “intrude impermissibly on the operation or enforcement of the FDCA.”  Id.  The FDA likes Buckman.
  • No state generally bans off-label promotion, only the FDCA, so “promotion” based claims involving off-label use are likely to be impliedly preempted.  In fact, we just saw another one of these the other day.  See Markland v. Insys Therapeutics, Inc., 2017 WL 4102300, at *9 (M.D. Fla. Sept. 15, 2017).
  • The FDA twice carefully qualified its discussion of §510(k) devices, recognizing that express preemption could exist where such a device was “otherwise subject to device-specific federal requirements.”  FDA Amicus br. at 6, 12. Good for limiting Lohr “on a case-by-case” basis.