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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.

Although they have nothing to do with the Affordable Care Act, health-care-related so-called “death panels” do exist.  These panels are operated by state agencies and private health insurance companies, and they decide whether to reimburse as “medically necessary” (or some similar definition) any type of medical care that comes into question.  They’re an unfortunate necessary – quackery should not be reimbursed.  But such panels used to reject any form of off-label use, until states and the federal government passed laws and regulations telling them that they couldn’t.  As we’ve explained elsewhere, off-label use can frequently represent the medical standard of care.

But in Harborth v. State, ex rel. Dep’t of Workforce Services, ___ P.3d ___, 2018 WL 4011635 (Wyo. Aug. 22, 2018), we ran into one of the limits to those protections – and to off-label use – that we haven’t seen in a published opinion in quite some time.  Something isn’t “off-label” when there is no FDA-approved label at all. The Wyoming Supreme Court affirmed a coverage denial of therapy involving the implantation of a medical device that had never been approved by the FDA for labeling and marketing for any intended use whatsoever.

How could that happen?

The FDA only regulates prescription medical products in the United States.  In Harboth, the claimant had a history of chronic back problems.  Ultimately the state worker’s compensation panel approved a rather expensive and involved surgical procedure:

a foraminotomy at L4-5 and transforaminal lumbar interbody fusions (TLIF’s) at both L5-S1 and T12-L1.  [Claimant] testified that [the recommended] surgery would cost approximately $400,000.

2018 WL 4011635, at *1.

Before agreeing to cover this surgery, the state required “two peer reviews.”  Id.  That took some time, and in the interim, the claimant got cold feet.  Id. at *2.  She was also in “excruciating pain” waiting for worker’s comp. to make up its mind.  Id. at *3.  The claimant investigated various treatments for her condition online, and learned about “artificial disc replacement surgery using the ‘M6’ artificial disc.”  Id. The surgeon who performed this procedure was in Germany.  The claimant crossed the pond and had the surgery.  Not only was it “successful,” but it cost a fraction of the $400,000 that the “death panel” was prepared to pay for the other type of surgery.  Id. at *4 (surgery was “appeared to be a success”), *10 (“surgery cost[] $340,000 less than [the initially proposed] procedure”).

The state’s version of a “death panel” nonetheless “denied compensation for the surgery, finding that it was not reasonable and necessary medical treatment.”  Id. at *3.

Why?

Because it could. The relevant reimbursement guidelines authorized payment for “off-label use,” but the M6 device had only received governmental approval for use in the European Union, and not from the FDA. Id. at *3 (“there has been no United States FDA approval of the M6-L disk replacement system”).

If the surgery had really been “off-label use” (ironically, a basis for the denial of the claim by the panel), then the claimant may have had a chance:

Rules recognize optional approaches to verifying that a procedure or device lacking FDA approval is reasonable and necessary. . . .  For “off-label use of medical services,” the health care provider must submit a comprehensive review of the medical literature supporting the off-label use, including “at least two (2) reliable prospective, randomized, placebo-controlled, double-blind trial[s].”

Harborth, 2018 WL 4011635, at *5 (citations to various rules omitted).

But the procedure had to involve “off-label use” in order to fit under these rules.  “‘Off-label use of medical services’ is defined as:  ‘Medications, treatments, procedures or other medical services used for other than the approved Food and Drug Administration (FDA) indications.’  Id. at *6 (citation and quotation marks omitted).  Off-label use is OK:

[O]nce the FDA has cleared a device for introduction into the stream of commerce, physicians may use the device in any manner they determine to be best for the patient, regardless of whether the FDA has approved the device for this usage.  This practice by physicians is known as “off-label” usage.

Id. (citation and quotation marks omitted).  But for the use of a device to be “off-label,” that device must first have been approved for marketing and labeling by the FDA for something.  The M6 wasn’t:

“[O]ff-label” medical service [i]s one that deviates from a use that has been approved by the FDA. . . . Under . . . the Division Rules, the plain definition of “off-label” use does not encompass the surgical implantation of an M6 artificial disc adjacent levels. The M6 artificial disc is not approved for any use by the FDA.  Thus, there is no “label” from which a medical provider may deviate.

Id. (citations and quotation marks omitted) (emphasis added).

Because the rules and regulations under which the state’s workers compensation system operated were “clear and unambiguous” in defining off-label use, nothing else mattered.  It didn’t matter that the claimant appeared to have a better prognosis (she returned to work, which was questionable under the other surgical alternative).  It didn’t matter that the surgical option the claimant pursued saved the state hundreds of thousands of dollars.

[Claimant] urges us to consider the success of her surgery as documentation of its safety and effectiveness. . . . [I]t may be tempting to weigh the actual outcome of surgery into the determination of compensability. Because [she] underwent surgery costing $340,000 less . . . and returned to her previous work duties with no restrictions and no pain medication, the evidence of her outcome is especially compelling. However, . . . it would be unreasonable to view the outcome of a medical procedure as a factor that trumps all others. [The] . . . Rules do not award compensation for medical treatments only if they are “successful” . . .; instead, in order to receive medical benefits, a claimant must show that his treatment is “reasonable and necessary.” A patient might fail to respond to reasonable and necessary medical treatment; and, likewise, a patient may benefit from elective, “unnecessary” medical treatment.

Id.  Anecdote, unfortunately for this claimant, is not data.  “A claimant’s successful surgery is only a single instance of success, and is not a substitute for objective and verifiable medical data demonstrating the procedure’s overall record for safety and effectiveness.”  Id.

It’s been a long time since we’ve seen a court draw this distinction.  In Gaston v. Hunter, 588 P.2d 326, 330 (Ariz. App. 1978), the court held that informed consent rules applicable to off-label use do not apply to an “experimental” medication that had not yet received FDA approval for anything, and was still under clinical investigation.  Similarly, in Retkwa v. Orentreich, 584 N.Y.S.2d 710 (N.Y. Sup. 1992), it was not off-label use to employ “liquid injectable silicone” in surgery where the material was not being sold as a medical device at all (a prior opinion in the same case called it “non-medical grade”).  “It is a reasonable assumption that most patients, confronted with a doctor’s recommendation for injection of a foreign substance, presume that such substance has been the subject of official testing, consideration, and approval.”  Id. at 712 n.6.

Whatever ones opinion of the third-party payor would-be “death panels,” and whether or not the “ends” in Harborth should have justified the means, the decision is a reminder that not everything that doctors do with FDA-regulated prescription medical products fits neatly into the two categories of “labeled use” (called “intended use” by the FDA) and “off-label use.”  With the Internet making ever more medical information (and disinformation) available without regard to national borders, we would not be surprised to encounter more cases where the distinction drawn in Harborth is relevant.

In the early days of the Blog, in 2009, when Bexis and Mark Herrmann were operating in relative obscurity, we posed the question whether it was ethical to remove to federal court a case that may well be non-removable and hope that opposing counsel is “asleep at the switch”:

“Heck, I’ll remove it anyway.  Opposing counsel may be asleep at the switch and not file a motion to remand within 30 days.  If plaintiff doesn’t timely move to remand, the objection to removal is waived, and my case can be tried to judgment in federal court.”

Is that ethical?

We received one response, which we discussed, that an:

attorneys’ first obligation should be to the integrity of the legal system, and not to their clients’ interests.  Even so, I’m not sure I’d say ‘no’ to either question, given that a yes answer means that incompetent attorneys who don’t realize they are violating the rules would have an advantage over competent attorneys.

With that the issue dropped off the radar.

That question returned to our minds when we researched our recent post on removal before service.  We came up with case after case holding that the so-called “forum defendant” rule was waivable, not jurisdictional, and thus that failure to move for remand in a case that featured complete diversity of the parties – but a defendant located in the forum state – was waiver so that the case stayed in federal court.  That means if a defendant is savvy enough to remove before service in accordance with the express terms of 28 U.S.C. §1441(b)(2), and opposing counsel is, as we said before, “asleep at the switch,” the removal succeeds regardless of a court’s substantive views on removal before service.

For example, in one of our removal before service cases, Selective Insurance Co. v. Target Corp., 2013 WL 12205696 (N.D. Ill. Dec. 13, 2013), the court held:

Plaintiff asserts §1441(b) (2) − the “forum defendant rule” − as a basis for remand, arguing that because defendant . . . is an Illinois citizen, removal was improper.  This rule is statutory, not jurisdictional, and thus may be waived or forfeited.

Id. at 1 (citing Hurley v. Motor Coach Industries, Inc., 222 F.3d 377, 379 (7th Cir. 2000)).  The cited Hurley decision held just that:

We must decide, therefore, whether the forum defendant rule is jurisdictional, in the sense we have been using the term, or if it is of a lesser status.  That question has been bouncing around the federal courts of appeals for more than 75 years, yet oddly enough it remains unresolved in this circuit.  The overwhelming weight of authority, however, is on the “nonjurisdictional” side of the debate.

Id. at 379. Hurley cited the following “overwhelming” precedent supporting the waivability of the forum defendant rule.  Snapper, Inc. v. Redan, 171 F.3d 1249, 1258 (11th Cir. 1999); Korea Exchange Bank v. Trackwise Sales Corp., 66 F.3d 46, 50 (3d Cir. 1995); In re Shell Oil Co., 932 F.2d 1518, 1522 (5th Cir. 1991); Farm Construction Services, Inc. v. Fudge, 831 F.2d 18, 21-22 (1st Cir. 1987); Woodward v. D. H. Overmyer Co., 428 F.2d 880, 882 (2d Cir. 1970); Handley-Mack Co. v. Godchaux Sugar Co., 2 F.2d 435, 437 (6th Cir. 1924), with only Hurt v. Dow Chemical Co., 963 F.2d 1142, 1145-46 (8th Cir. 1992), going the other way.

Another pre-service removal case reached the same conclusion.  The court in Almutairi v. Johns Hopkins Health System Corp., 2016 WL 97835 (D. Md. Jan. 8, 2016), stated:

I am unaware of any specific guidance from the Supreme Court or the Fourth Circuit concerning whether a motion to remand based on the “forum defendant rule” constitutes a procedural or a jurisdictional challenge to removal.  See Councell v. Homer Laughlin China Co., 823 F. Supp. 2d 370, 378 (N.D.W. Va. 2011) (recognizing that the Fourth Circuit “has yet to rule on this question…”).  However, “[o]f the ten circuits that have spoken on the issue, nine have found that removal by a forum defendant is a procedural defect, and thus waivable.”  Id.

Almutairi, 2016 WL 97835, at *5.  In addition to the cases previously cited by Hurley, Almutiari added:  Lively v. Wild Oats Markets, Inc., 456 F.3d 933, 939-40 (9th Cir. 2006), Handelsman v. Bedford Village Assocs. Ltd. Partnership, 213 F.3d 48, 50 n.2 (2d Cir. 2000), Blackburn v. United Parcel Service, Inc., 179 F.3d 81, 90 n.3 (3d Cir. 1999), and Pacheco de Perez v. AT & T Co., 139 F.3d 1368, 1372 n.4 (11th Cir. 1998).

So at least in the context of removal before service, we now unhesitatingly answer our question from 2009 in the affirmative.  By all means remove before service, even in the face of adverse precedent in some district courts.  At best, the plaintiff will miss the issue entirely and will waive any reliance on the forum defendant rule (which is waivable everywhere but in the Eighth Circuit).  At worst, (1) the case is randomly assigned to a federal who has already ruled adversely, and (2) the plaintiff seeks remand in a timely fashion.  In that situation, as our recent removal-before-service posts demonstrate, the defense side has both the upper hand in the argument, and significant appellate support.  See, e.g., Encompass Insurance Co. v. Stone Mansion Restaurant, Inc., ___ F.3d ___, 2018 WL 3999885, at *4-5 (3d Cir. Aug. 22, 2018); Novak v. Bank of N.Y. Mellon Trust Co., 783 F.3d 910, 912, 914 (1st Cir. 2015); La Russo v. St. George’s University School, 747 F.3d 90, 97 (2d Cir. 2014).  A combination of persuasive argument and recent arguments might get a fair-minded judge to change his/her mind.  Even the worst possible result – remand accompanied by an order to pay counsel fees – isn’t all bad, since the sanctions order would be immediately appealable.

But we want to make one thing perfectly clear.  Pre-service removal involves only statutory language relating to diverse “forum defendants.”  There is nothing in the statute, or in the case law, that allows the presence of a non-diverse defendant to be avoided by pre-service removal.  Pre-service removal does not make non-diverse cases diverse.  Any counsel who screws up this fundamental distinction deserves whatever sanctions a court hands out.

 

Today’s guest post is by frequent contributor Dick Dean of the Tucker Ellis firm.  This time, Dick is sharing some insights on Wyeth v. Levine, 555 U.S. 555 (2009), which we consider the single worst prescription medical product decision since we started blogging.  Not surprisingly, Dick shares our views of Levine.  We agree with him.  Further, if Levine had been decided the way Dick advocates, all of the subsequent preemption focus on “independent”action, “major” changes and “newly acquired” information could have been avoided, and a more rational system turning on the substance of the conflict would have ensued.

As always, our guest bloggers are 100% responsible for the contents of their posts, deserving of all the credit (and any blame) for what they have written.

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Cases involving the “purposes and objectives” obstacle part of the implied preemption doctrine are rare.  The recent decision in Fontana v. Apple, Inc., ___ F. Supp. 3d ___, No. 2:18-cv-00019, 2018 WL 3689044 (M.D. Tenn. August 3, 2018), is a reminder of the efficacy of this powerful, but little used, defense.  Plaintiff brought a personal injury action claiming he developed cancer from the use of a cell phone.  In the 1990s these claims were addressed by extensive Daubert practice.  But this claim was dismissed at the pleadings stage because it interfered with the FCC’s ability to carry out its mission of setting radio frequency emission levels established by the Telecommunications Act of 1996.  It was specifically based on “purposes and objectives” obstacle preemption.  That is good for the cell phone industry but does it “speak” to us in the pharmaceutical defense world?  Indeed it does.  Fontana relied heavily on Farina v. Nokia Inc. 625 F.3d 97 (3rd Cir. 2010) [ed. note: blogged about here], finding a similar claim obstacle preempted, and Robbins v. New Cingular Wireless PCS, LLC, 854 F.3d 315 (6th Cir.2017) (barring an attempt to prohibit the building of a cell tower based on health reasons finding obstacle preemption).  The rationale of Fontana, Farina and Robbins is straightforward:

The reason why state law conflicts with federal law in these balancing situations is plain.  When Congress charges an agency with balancing competing objectives, it intends the agency to use its reasoned judgment to weigh the relevant considerations and determine how best to prioritize between these objectives.  Allowing state law to impose a different standard permits a re-balancing of those considerations.  A state-law standard that is more protective of one objective may result in a standard that is less protective of others.

Farina, 625 F.3d at 123 quoted by Fontana, 2018 WL3689044 at *2.

Allowing juries to impose liability on cell phone companies for claims like [plaintiff’s] would conflict with the FCC’s regulations.  A jury determination that cell phones in compliance with the FCC’s SAR guidelines were still unreasonably dangerous would, in essence, permit a jury to second guess the FCC’s conclusion on how to balance its objectives.

Farina, at 125-6 quoted by Fontana at *3.

Of course, the parallel to FDA determinations about efficacy and safety of drugs and the sufficiency of labels is striking.  The FDA engages in a classic weighing process as to whether a drug can come on the market and what its label should say.  Its processes are far more detailed than those of the FCC which played out in these three cases.  But jury second guessing of pharmaceutical labels is permitted by the Supreme Court in Wyeth v Levine, 555 U.S. 555 (2009), where the Court rejected preemption because of the manufacturer’s ability to submit a change in the label.  But that leaves the second issue in Wyeth—who should decide adequacy.  The three-Justice dissent (Alito, Roberts and Scalia) fully adopted the “purposes and objectives” argument—that the FDA should make these decisions and not be second-guessed by juries as to labeling decisions.

It should first be noted that even given Wyeth, there are areas within the pharmaceutical area where “purposes and objectives” preemption has been applied.  That is exactly what happened in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 353 (2001) (finding state law fraud on the FDA claims to be impliedly preempted).  It also happened in Zogenix v. Patrick, No. 14-11689, 2014 WL 1454696 (D. Mass. Apr. 15, 2014) [ed. note: blogged about here], where Massachusetts state rules made it impossible to market an opioid approved by the FDA.  These rules were struck down since they interfered with the FDA’s ability to carry out its mission of regulating drugs.  Specific reliance was placed on the purposes and objectives portion of implied preemption.

The power of the reasoning in Fontana, Farina and Robbins merits a review the of Wyeth analysis of “purposes and objectives” preemption.  The Wyeth majority’s rejection of the “purposes and objectives” claim is thin and wanting.  It is an afterthought to an opinion that deals primarily with impossibility preemption given the provisions of the “changes being effected” provision.  It is at odds with prior Supreme Court precedent on “purposes and objectives” in Geier v. Am. Honda Motor Co., 529 U.S. 861, 881 (2000) (finding obstacle preemption based on a general rule of the Department of Transportation favoring a “mix of seat restraints), and with subsequent precedent in Arizona v. United States, 567 U.S. 387 (2012) (an immigration case).  In Wyeth, the Court first noted that Congress had long recognized a role for state law causes of action under the FDCA.  Id. at 574–75.  But the fact that some state actions may be “complementary” does not mean that others may not be at cross purposes. Second, the court coupled the “complementary” argument with the fact that there was no express preemption provision in the FDCA.  Id.  But the Supreme Court itself has consistently held that the lack of finding of express preemption does not bar implied preemption.  See Geier, 529 U.S. at 869; Buckman, 531 U.S. at 352.  Third, it refused to consider the “new” FDA legal position on preemption.  An agency position is certainly not conclusive to whether there is “purposes and objectives” preemption, since the position of the United States on this issue is a changing one dependent on the politics of the administration in power. Moreover, implied preemption is not dependent on the FDA advancing that position.  PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (where implied preemption was found over agency objection).  But the major failure was that the Wyeth majority did not compare the entire federal regulatory scheme to the state jury system on the issue of who should decide adequacy; it demanded a specific regulation at odds with the jury system.  Wyeth, 555 U.S. at 580.  It distinguished Geier finding there was a “specific rule” in conflict with state tort lawsuits, but that rule was only that the Department of Transportation allowed a “mix” of restraint systems.  The generality of that “rule” does not begin to compare with the detailed federal regulations on drug approval and labeling decisions.  Simply put, the majority in Wyeth used an incorrect legal test to determine whether there was “purposes and objectives” preemption.

Wyeth, however impaired, is still the law.  But precedents do get changed.  And the Supreme Court’s treatment of this issue after Wyeth helps to demonstrate that Wyeth was wrong in its “purposes and objectives” analysis.   In Arizona v. United States the Supreme Court confronted a preemption challenge to a number of Arizona statutes involving immigration.  One such statute, section 6 of Arizona S.B. 1070, provided that a state officer could arrest someone if the officer had probable cause to believe that a person was “removable” from the country.  The United States argued that this statute was an obstacle to the “removal” system created by federal statutes and regulations.  Section 5 of the state legislation made it a misdemeanor for an unauthorized alien to apply for work in Arizona.  The government argued that was at odds with federal legislation making a specific choice not to impose criminal liability for this conduct.  The Supreme Court agreed that these statutes did create an obstacle to the full “purposes and objectives” of Congress.  567 U.S. at 406–07, 410.  It looked at what was provided for by each regulatory scheme and determined whether there was a conflict between them.

Presuming that Judge Gorsuch would follow the Scalia position in Wyeth—that has three Justices supporting that position.  Justice Thomas does not generally agree with “purposes and objectives” preemption.  But U.S. v. Arizona may be viewed by new Justices as a basis to reevaluate the Wyeth position of “purposes and objectives” preemption.  Justice counting aside, the reasoning of this part of Wyeth makes no sense.

That said, a note of caution is in order.  Cases where this defense is advanced in the pharmaceutical area should be carefully chosen with careful consideration given to the facts and the judges involved.  Enough bad law has already been made in this area.  In the short term, fact patterns like Zogenix where the state tries to intrude into the regulatory area cry out for this defense.  Using it now in a typical failure to warn claim is not likely to succeed.  But Wyeth’s reasoning is subject to challenge.  As other industries get the “cell phone” treatment on “purposes and objectives” preemption, this disparity will increase the focus on that reasoning.

On August 17, 2018, we observed in our latest comprehensive post on pre-service removal, that “[w]ith Court of Appeals decisions now breaking in our favor, we can start trying to change the minds of district courts that have previously gone the other way.”

And how.

On August 22 – less than a week after that post (and while Bexis was on vacation) – the Third Circuit came down strongly on the “plain meaning” side of the ledger in a removal-before-service case and flatly rejected the “absurd result” rationale that some district courts in that circuit had developed.  See Encompass Insurance Co. v. Stone Mansion Restaurant, Inc., ___ F.3d ___, 2018 WL 3999885 (3d Cir. Aug. 22, 2018).  The court first examined the purpose of the “forum defendant” exception to removability of diverse cases and Congress’ amendment adding the “properly joined and served” language that supports pre-service removal:

We therefore turn to section 1441, which contains the forum defendant rule.  Section 1441 exists in part to prevent favoritism for in-state litigants, and discrimination against out-of-state litigants.  The specific purpose of the “properly joined and served” language in the forum defendant rule is less obvious.  The legislative history provides no guidance; however, courts and commentators have determined that Congress enacted the rule to prevent a plaintiff from blocking removal by joining as a defendant a resident party against whom it does not intend to proceed, and whom it does not even serve.

Id. at *4 (citations and quotation marks omitted).

Next, the court examined the competing arguments – “plain meaning” on the defense side, and “absurd result” on the plaintiff side. The facts were rather stark – after initially unconditionally agreeing to accept service, defense counsel notified plaintiff that he would not do so until after he had first removed the case to federal court.  Id. at *1-2.  Although “not condon[ing] this conduct between and among legal practitioners,” the district court denied remand given the express language of 21 U.S.C. §1441(b).  See Encompass Insurance Co. v. Stone Mansion Restaurant, 2017 WL 528255, at *2 & n.1 (W.D. Pa. Feb. 9, 2017).  The Third Circuit affirmed:

Citing this fraudulent-joinder rationale, [plaintiff] argues that it is “inconceivable” that Congress intended the “properly joined and served” language to permit an in-state defendant to remove an action by delaying formal service of process. This argument is unavailing.  Congress’ inclusion of the phrase “properly joined and served” addresses a specific problem − fraudulent joinder by a plaintiff − with a bright-line rule.  Permitting removal on the facts of this case does not contravene the apparent purpose to prohibit that particular tactic.  Our interpretation does not defy rationality or render the statute nonsensical or superfluous, because:  (1) it abides by the plain meaning of the text; (2) it envisions a broader right of removal only in the narrow circumstances where a defendant is aware of an action prior to service of process with sufficient time to initiate removal; and (3) it protects the statute’s goal without rendering any of the language unnecessary.  Thus, this result may be peculiar in that it allows [defendants] to use pre-service machinations to remove a case that it otherwise could not; however, the outcome is not so outlandish as to constitute an absurd or bizarre result.

2018 WL 3999885, *4 (footnotes omitted) (emphasis added).

The omitted footnotes are also significant.  First, the “general rule” that “by interpretation we should not defeat Congress’ purpose of abridging the right of removal” was “not sufficient to displace the plain meaning of the statute.”  Id. at *4 n.3 (citing and quoting Delalla v. Hanover Insurance Co., 660 F.3d 180, 189 (3d Cir. 2011)).  Second, the argument that advanced technology allowing improved docket monitoring was more properly directed to Congress than to the courts:

We are aware of the concern that technological advances since enactment of the forum defendant rule now permit litigants to monitor dockets electronically, potentially giving defendants an advantage in a race-to-the-courthouse removal scenario. . . .  If a significant number of potential defendants (1) electronically monitor dockets; (2) possess the ability to quickly determine whether to remove the matter before a would-be state court plaintiff can serve process; and (3) remove the matter contrary to Congress’ intent, the legislature is well-suited to address the issue.

Id. at *4 n.4.

The Encompass Insurance court therefore unanimously concluded that §1441(b) said what it said when it predicated the forum defendant exception on such defendants being “properly joined and served” and that courts must respect what Congress enacted:

In short, [defendant] has availed itself of the plain meaning of the statute, for which there is precedential support.  [Plaintiff] has not provided, nor have we otherwise uncovered, an extraordinary showing of contrary legislative intent.  Furthermore, we do not perceive that the result in this case rises to the level of the absurd or bizarre.  There are simply no grounds upon which we could substitute [plaintiff’s] interpretation for the literal interpretation.  Reasonable minds might conclude that the procedural result demonstrates a need for a change in the law; however, if such change is required, it is Congress − not the Judiciary − that must act.

Id. at *5.  Finally, the defendant’s previous agreement to accept service did not preclude it from delaying such acceptance until after it removed the case to federal court.  “[W]e are unconvinced that [defendant’s] conduct − even if unsavory − precludes it from arguing that incomplete service permits removal.”  Id.

Thus, the debate is over in the Third Circuit, notwithstanding the prior decisions of some district judges in Pennsylvania, New Jersey, and Delaware to the contrary, and it is perfectly proper for defendants, whether “forum defendants” or otherwise, to monitor state-court dockets electronically for new lawsuits, and to remove diverse cases preemptively to federal court before the plaintiffs (often litigation tourists) can serve in-state defendants whose presence would otherwise preclude removal under §1441(b)(2).

The sound you hear is one more nail being driven in the coffin of litigation tourism.

One last thought.  Query whether, if a defendant in a case in the Third Circuit were unfortunate enough to have removed before service and suffered remand under the “absurd result” rationale rejected in Encompass Insurance, the Third Circuit’s opinion constitutes an “other paper” creating grounds for removal that would support a second removal.  While we don’t know the answer off-hand, it is a question that attorneys representing clients in that situation may want to address.

We confess – when we first considered the spate of eye drop class actions a few years ago, we had trouble taking them seriously.  It was tough to get excited about penny-ante allegations that the size of eye drops warranted the attention of federal courts, or warranted class action status.  We were not alone in that assessment.  See Eike v. Allergan, Inc., 850 F.3d 315 (7th Cir. 2017) (discussed here).

But the judicial skepticism engendered by pathetically weak and blatantly lawyer-driven litigation can produce collateral benefits – like favorable preemption decisions.  We hailed the first of those, Thompson v. Allergan USA, Inc., 993 F. Supp.2d 1007 (E.D. Mo. 2014), in our “Mensing – It’s Not Just About Generics Anymore” post over four years ago.  Thompson held that the plaintiffs’ attacks on the size of the eye drops was a challenge to the FDA-approved dose of that product.  Dosage alterations, however, were “major changes” that required FDA pre-approval.  The need for such pre-approval, however, barred the claim under the impossibility preemption rationale of Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), and PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).

We also considered Thompson as proof that we hadn’t been “baying at the moon” in our 2013 “‘Major’ Drug Labeling Changes That Require FDA Prior Approval” post, where we listed a bunch of drug-related changes that the FDA considered “major” and argued that they should all be preemptive under the Mensing/Bartlett rationale.

Thompson didn’t go any further, but a Massachusetts district court reached essentially the same result in Gustavsen v. Alcon Laboratories, Inc., 272 F. Supp.3d 241 (D. Mass. 2017):

FDA regulations, as interpreted by the FDA, now prevent defendants from changing the “size and/or shape of a container for a sterile drug product” unless and until the FDA determines that its benefits outweigh any harms.  The decision whether such a change should be made is, therefore, reserved for FDA, and the Supremacy Clause prohibits judges and juries from displacing or second-guessing the FDA based on the laws of Massachusetts or other states.

Id. at 255-56 (citation to same FDA guidance cited in our 2013 post omitted).  Oddly, Thompson was not cited in Gustavsen.  We blogged about that decision here.

A few days ago, the First Circuit affirmed, in Gustavsen v. Alcon Laboratories, Inc., ___ F.3d ___, No. 17-2066, 2018 WL 4057381 (1st Cir. Aug. 27, 2018), and that decision is a preemption home run.  Gustavsen decided a “single question” – “Can manufacturers of prescription eye drops change the medication’s bottle so as to alter the amount of medication dispensed into the eye without first getting the FDA’s approval?”  The answer to that question being “no,” “state law claims challenging the manufacturers’ refusal to make this change are preempted.”  Id. at *1.

The major dispute in Gustavsen wasn’t the law.  Even plaintiffs appeared to concede that preemption flowed from a “prior agency approval” requirement under Mensing/Bartlett:

The principles of federal preemption that control our disposal of this appeal are not in dispute.  If a private party (such as the manufacturers here) cannot comply with state law without first obtaining the approval of a federal regulatory agency, then the application of that law to that private party is preempted.  Conversely, a private party’s ability to do without prior agency approval that which state law requires defeats a preemption defense even if the federal regulatory agency retains authority to reject the changes, unless the defendant establishes by clear evidence that the agency would, in fact, reject the changes.

Id. (citations and quotation marks omitted).

The disputed question was whether a tort-required change to the dispenser of a drug (here, eye drops) that had the effect of reducing the size of the drop – and thus the dosage of the drug in that drop – required FDA prior approval.  The pertinent FDA regulation, 21 C.F.R. §314.70 (another part of which, (c)(6)(iii), is Levine’s notorious  “CBE regulation”),

divid[es] changes into three categories: major, moderate, and minor changes.  The classification of the manufacturer’s anticipated alteration into one of these three categories dictates the manufacturer’s ability to unilaterally implement its change.  Major changes require approval from the FDA prior to implementation, while moderate and minor changes do not.

Gustavsen, 2018 WL 4057381, at *5 (emphasis added).

Controlling case law is clear − and plaintiffs here concede − that if the change they contend state law requires qualifies as “major,” then federal law preempts plaintiffs’ cause of action because defendants cannot lawfully make such a change without prior FDA approval.

Id.  That’s the key.  Gustavsen’s main takeaway is its holding that “if the change [plaintiffs] contend state law requires qualifies as “major,” then federal law preempts plaintiffs’ cause of action.”  Id. (emphasis added).  That’s precisely what we first argued back in 2013:  that where certain “changes are considered sufficiently ‘major’ that they require FDA prior approval . . . those sorts . . . [of] changes should be preempted” by Mensing/Bartlett.

Much of the remaining preemption discussion in Gustavsen was to reject plaintiff-side pettifoggery.  The First Circuit ruled that §314.70(b) was properly read to include subsection (b)(1)’s “broad category of qualifying changes” as “major” – including “sections (b)(2)(i) through (viii).”  2018 WL 4057381, at *6.  Rejecting plaintiffs’ attempt to parse the regulation in a cramped fashion, Gustavsen “conclude[d] that, if a change fits under any of the categories listed in section (b)(2), that change necessarily constitutes a ‘major’ change requiring FDA pre-approval.”   Id. (emphasis added).  One of those categories, §314.70(b)(2)(vi), was a “comfortable” fit for the plaintiffs’ dosage claims, thus mandating preemption.  Gustavsen, 2018 WL 4057381, at *7.  Like the district court, the First Circuit in Gustavsen relied upon, inter alia, the same FDA guidance that we did back in 2013.  Id. at *8.

Finally, the First Circuit rejected each of the plaintiffs’ three “retorts.”  First, “[w]e do not share plaintiffs’ reading of the preamble” to the Federal Register notice that finalized §314.70, id., and “[i]n any event, it is well-established that a regulatory preamble is incapable of altering regulatory text’s plain meaning.”  Id. (citation omitted).  Second, the dosage was not “one drop” of any size.  Id. at *9.  Third, allegations that the FDA had, in practice, not always enforced the pre-approval requirement as to eye drops did not trump the regulation itself, since “the regulatory actions to which plaintiffs point” were “made by mid-level FDA scientists, or even a single ‘reviewer,’” and thus did not “reflect” the FDA’s “fair and considered judgment.”  Id.

We think Gustavsen is a big deal, since its logic extends far beyond the rather trivial allegations ginned up by the class action lawyers who have pursued the eye drop litigation.  There are a lot of potential drug-related changes that the FDA considers “major” under the regulation and guidance documents relied upon in Gustavsen.  These include “changes in the qualitative or quantitative formulation of the drug product, including inactive ingredients, or in the specifications provided in the approved NDA.”  §314.70(b)(2)(i) (emphasis added).  In other words, as we concluded when we first discussed Thompson, “We hasten to add that the same argument preempts all design defect claims against FDA-approved products since all design changes require pre-approval.”  Plaintiffs also frequently assail defendants for not more thoroughly testing their products.  Well, “major” changes also include “[c]hanges requiring completion of studies” and “[c]hanges to a drug product under an NDA that is subject to a validity assessment because of significant questions regarding the integrity of the data.”  Id. §(b)(2)(ii) and (viii).  A number of label changes, including to “highlights” and to “medication guides” are also “major.”  Id. §(b)(v)(B-C).

The Gustavsen rationale – “major” change = FDA pre-approval = preemption − should also apply to medical devices, since modifications to devices follow a similar regulatory framework:

(a) . . . [E]ach person who is required to register his establishment . . . must submit a premarket notification submission to the Food and Drug Administration . . . days before he proposes to begin the introduction or delivery . . . of a device intended for human use which meets any of the following criteria:

*          *          *          *

(3) The device is one that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use.  The following constitute significant changes or modifications that require a premarket notification:

(i) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.

(ii) A major change or modification in the intended use of the device.

21 C.F.R. §807.81(a) (emphasis added).

Finally, the Gustavsen rationale – being a basis for implied preemption – is not necessarily limited to the FDCA.  To the extent that other products are subject to federal pre-approval, they, too, may have a preemption defense available.  We don’t claim to be experts in such products, but one example that comes to mind is aviation, where FDCA “conflict preemption principles” have already been applied in at least one case.  See Sikkelee v. Precision Airmotive Corp., 822 F.3d 680, 702-03 (3d Cir. 2016).

Sometimes bad litigation can make very good law.

This guest post is by Reed Smith‘s Matt Jacobson.  Matt is interested in the intersection between 3D printing and product liability, and the article he discusses is just too much to pass up.  As always our guest posters are 100% responsible for their content, deserving of all the credit and any blame.

**********

Walter White, the high school chemistry teacher turned methamphetamine “manufacturer” and main protagonist in the TV show Breaking Bad, has been called a lot of things.  Drug king pin.  Villain.  Criminal mastermind.  Heisenberg.  Visionary?

For the handful of you who have not seen Breaking Bad or are not regular readers of this blog (Walter White appears in at least three prior posts), Walt was a depressed high school chemistry teacher diagnosed with stage III lung cancer. Wanting to ensure his family’s financial security after his death, he gets into the business of manufacturing methamphetamines and drug dealing.  Before he is pulled deeper into the illicit drug trade and his character evolves from teacher/family man into murderer/crime lord, Walt turns an RV into a rolling meth lab.

So visionary may not be the right word, at least not until now. Spoiler alert—it’s been almost seven years since Walter White’s death (yes we believe he really did die) and now a group is following in Walt’s footsteps, manufacturing drugs at home using a micro (not meth) lab—well that is not exactly what it is doing, but it provides good imagery.  So imagine, that instead of meth, Walt manufactures a drug for opiate overdose (might actually be good for his business) or to treat infections in HIV patients.  And instead of beakers in the RV, Walt uses a few mason jars and a 3D printer.  If this had been the story’s line, the show’s creators may have had to change the title to Breaking Good, which doesn’t seem to have as nice of a ring to it.

Ok, back to reality.  Recently, an article appeared in 3D Printing Industry about a group trying to do just that.  The group calls itself Four Thieves Vinegar Collective (taking the name from an alleged plague cure) and according to its website, its mission is “free medicine for everyone.”  Following the footsteps of 3D printed gun proselytizer Defense Distributed, Four Thieves recently released instructions for building an “Apothecary MicroLab,” a DIY kit claimed to be able to synthesize a variety of medications.

As they say on TV, do not try this at home. Beyond a glass of warm milk for insomnia and salted water to gargle when your throat is sore, making your own medicine at home is a really bad idea, with potentially adverse consequences.  For those, however, with a (morbid) curiosity, the article explains the kit’s makeup:

[A] small mason jar mounted inside a larger mason jar with a 3D printed lid. Furthermore, the kit contains a 3D printed stepper motor, syringe pump, coupler and shredded shaft which are connected using small plastic hoses.  A thermistor is then attached through the lid to circulate fluids to induce the chemical reactions necessary to manufacture various medicines.  The whole process is automated using a computer.

Apparently, “the 3D printed chemical reactor kit has successfully produced Naloxone (aka Narcan), a drug for opiate overdoses, Cabotegravir and Daraprim, drugs used to treat infections in people with HIV, and Mifepristone (aka RU486), and misoprostol,” two pharmaceuticals that can be used to terminate pregnancies.

Four Thieves Vinegar Collective is not selling the drugs itself—it is providing instructions on how to make the medications. The drugs themselves are also not 3D printed—although some of the parts in the kit are made using a 3D printer.  So maybe this is not a modern day Walter White situation after all.  But this article did raise questions.  There is already one pharmaceutical drug being (legally) manufactured using a 3D printer.  With an aging population and disease not going away anytime soon, 3D printing of medicines in our own homes might be in our future.  Some might even say it is only a matter of time.  Will the law—both regulatory and the product liability system—is ready for it?

Because this blog not only geeks out about good TV shows, but also about the law and 3D printing, consider some of the product liability implications that are raised by 3D printing drugs out of a person’s home.

Manufacturing defects

Injuries caused by an improperly manufactured or tainted 3D printed drug is an issue. This may be the result of an error in the instructions being used, problems with the 3D printer, quality control issues in the person’s home where the drug is “printed,” or how the person synthesizes the drug—in other words, any situation in which a mistake occurs at any point in the process used to print the drug can create a manufacturing defect.  Manufacturing defects are an infrequently litigated product liability claim where FDA-approved drugs are at issue.  However, in the case of 3D printing homemade drugs, it may very well be the main focus of litigation.  If a person makes a drug in his or her house using a 3D printer, who does that person blame if the drug causes injury?  Would the person making the drug be considered the manufacturer for strict liability purposes?  Under section 402A of the Restatement (Second) of Torts, the seller or manufacturer must be engaged in the business of selling the product. The home drug maker may or may not be in the business of drug manufacturing.  It would depend on whether the that person also distributes the basement drugs to others. So who would be liable?  A potential defendant may be the manufacturer of the 3D printer with a plaintiff claiming the “defect” arose because of some aspect of the printer. Another potential party may be the entity who provided the instructions for making the drug with a claim for “defective instructions.”  That could include the Four Thieves Vinegar Collective itself.  Product liability law may need to evolve to address these issues, but it is clear that printing drugs from your home will blur the distinctions between the user and the manufacturer of the drugs.

Warnings

Injuries could be caused by a failure to provide adequate or accurate warnings regarding a dangerous side effect or a failure to provide adequate instructions regarding the safe and appropriate use of the drug—or possibly the above-described “Micro Lab,” or even the 3D printer.  For FDA-regulated prescription drugs and medical devices, the learned intermediary doctrine provides that a manufacturer need only warn a prescribing doctor about known or knowable risks.  It is not obligated to warn the end user.  Because physicians are typically warned about drugs through medical literature and via manufacturer-created warning labels/disclosures that accompany the drugs, the learned intermediary doctrine will not apply to 3D printed homemade drugs.  Such drugs would need to be accompanied by adequate warnings directed to the consumers themselves.  These warnings should disclose the reasonably foreseeable risks of the medication (e.g., adverse reactions) and dosage requirements.  In the 3D printing context, if no traditional product “manufacturer” exists, it is likely that a duty to warn (perhaps only in negligence) will ultimately be imposed on some other entity involved in the supply chain.   But if a person is 3D printing drugs from home who would be responsible for providing the warnings? Would it be the person or company who is providing the instructions on how to synthesize the drug?  If the instructions are downloaded from a website, a plaintiff may find it virtually impossible to identify this person, let alone find them to effectuate a lawsuit.

FDA

As far as we can tell, the FDA has not yet issued any statements about the “Apothecary MicroLab” or 3D printing drugs from your home.  The FDA did issue a statement about Four Thieves Vinegar Collective’s other product, the EpiPencil (a homemade epinephrine autoinjector that can be built for $30), saying with remarkable understatement that it was a “potentially dangerous practice.” For the most part, the FDA has been silent on the 3D printing of drugs (no matter where it happens), with the exception of the one 3D printed drug that it approved.

As to 3D printing drugs at home, how the FDA intends to approach this subject is very unclear. A lot of questions are raised with no answers as of yet.  If manufacturing occurs at a non-traditional “manufacturing” site, such as a person’s home, how will or should the FDA regulate that site? Should the site be subject to all of the FDA’s requirements and standards and will the FDA take enforcement action because a 3D printed drug is technically adulterated when it is not manufactured under quality compliant conditions?  Will instructions to print drugs have to be FDA approved?  Will the FDA regulate the printer or just the finished product?  To resolve these and other issues, the FDA may need to modify its regulations, and in the short term issue a few guidance documents and exercise its enforcement discretion for some FDA rules and regulations.  FDA’s requirements will be key for safety, but also for preemption purposes, which may depend on the FDA imposing requirements on 3D printing of medications.

 

Quality Control

There likely would be no way to have quality control measures in place for every home that is 3D printing medications. Certainly, the FDA could not enforce its inspection procedures in every household that was 3D printing drugs. On its website, Four Thieves Vinegar Collective says that quality control issues are not the same when making small quantities of a drug as opposed to an industrial scale. That is doubtful, at best. While it may be easier to control quality if you are only making one pill, quality control is still a huge issue when it comes to medications. A person’s home is not nearly as clean as a drug lab. A person likely would not have records of the formulation of the product, synthesis of the substance, and the specifications of the products readily available to ensure all are met. Also each drug that is 3D printed, or even a sampling, would not be tested, let alone retested, before use. Each 3D printer would have to be calibrated before use. Microbiological factors may also come into play, such as evaluating the raw material for sterility, endotoxins, and environmental concerns. These same issues also effect recalls, and recalls probably would be limited to 3D printers and centrally manufactured products or become voluntary. There are good reasons why the FDA exists.

 

Like the fictional character Walter White, 3D printing drugs from your home is still not a reality. Four Thieves Vinegar Collective and other organizations like it are making it more likely that it could happen sometime in the future, whether legal or not. A lot of potential uses of 3D printing drugs exist, from helping soldiers on the battlefield to people in less developed countries.  Until the technology and legal issues are dealt with, there are still a lot of risks and dangers associated with 3D printing medications. Right this moment, making any kind of drug yourself is far from advisable. But for now, thinking about all these product liability issues is what get us high. And we can only wonder if Walter White’s lawyer Saul Goodman would have advised him of these risks? Certainly not.

 

 

In medical device product liability cases to which preemption by reason of FDA pre-market approval (“PMA”) applies, courts have consistently misinterpreted the Supreme Court’s dictum in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) − finding the plaintiff’s “parallel” violation claims waived by failure to assert in the court of appeals – as somehow endorsing such claims.  Of course, only those PMA plaintiffs able to take advantage of prior FDA enforcement actions (usually, but not exclusively, warning letters or recalls) really have any basis to raise so-called “parallel” claims, but that certainly won’t stop other plaintiffs desperate to avoid preemption.

Lacking factual basis to make a valid parallel claim, such plaintiffs frequently try to bluff their way through by burying their opponents in garbage.  Typically, this ploy takes the form of a “laundry list” of allegations that the defendant’s device violated just about every FDA good manufacturing practice (“GMP” or “CGMP” in the cases) in the title 21 of Code of Federal Regulations, and for good measure, sometimes other regulations as well.  These allegations often go on for several pages in a complaint, with no hint of what exactly the defendant did that was in violation, and even less about how any of these purported violations caused any injury to this particular plaintiff.

Fortunately, most courts are willing to use TwIqbal to call bull$%@&! on these types of allegations.  “To plead a parallel claim successfully, a plaintiff’s allegations must meet the plausibility standard articulated by the Supreme Court in Iqbal and Twombly.”  Shuker v. Smith & Nephew PLC, 2015 WL 1475368, at *13 (E.D. Pa. March 31, 2015), aff’d, 885 F.3d 760 (3d Cir. 2018).  “[M]ore is required to make out a parallel claim than conclusory statements that a defendant violated multiple regulations.”  Swisher. v. Stryker Corp., 2014 WL 1153716, at *2 (W.D. Okla. March 14, 2014).  “Plaintiff must do more than simply allege the existence of the regulation, and then state that Defendants violated it.” Grant v. Corin Grp. PLC, 2016 WL 4447523, at *6 (S.D. Cal. Jan. 15, 2016).

One of the first cases to encounter, and to dispatch, this kind of abusive pleading was Ilarraza v. Medtronic, Inc., 677 F. Supp.2d 582 (E.D.N.Y. 2009).  Since the complaint in Ilarraza “goes on to list eleven federal regulations alleged to have been violated,” id. at 583, the opinion needed over two  pages just to explain the regulations that plaintiff claimed that the defendant violated.  Id. at 586-88.  However, “no regulation relied upon refers specifically to the medical device at issue here.”  Id. at 588.  TwIqbal therefore barred the claims:

[W]here, as here, a plaintiff relies on nothing more that CGMP’s in support of a parallel cause of action, preemption bars the claim. . . .  Plaintiff’s claim cannot withstand the pleading requirements [that] . . . require dismissal of complaints that do nothing more than engage ion a “formulaic recitation of the elements of a cause of action.  Where, as here, the plaintiff has done nothing more that recite unsupported violations of general regulations, and fails to tie such allegations to the injuries alleged, the complaint is properly dismissed.

*          *          *          *

Here, Plaintiff fails to set forth any specific problem, or failure to comply with any FDA regulation that can be linked to the injury alleged.

Id. at 588, 589 (Twombly citations omitted).

Another early pleading case is In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D. Minn. 2009), in which MDL plaintiffs, after Riegel was decided, loaded up their master complaint with lots of alleged regulatory violations.  Id. at 1153-54.  Dismissing the complaint, the court held:

Plaintiffs’ failure to allege in detail the federal requirement(s) purportedly violated by Medtronic also raises the specter of Twombly. . . .  Hence, their assertion that the [device] did not comply with the CGMPs/QSR is insufficient, without more, to save their claims. Under Twombly, Plaintiffs were required to provide enough factual detail in the Complaint to alert [defendant] of the “grounds” upon which their manufacturing-defect claim rests. Merely alleging that [defendant] failed to comply with the CGMPs/QSR . . . is insufficient without some factual detail about why that violates federal standards.

Id. at 1158 (citations and quotation marks omitted).  The Eighth Circuit affirmed, holding, in pertinent part, that “Plaintiffs simply failed to adequately plead that [defendant] violated a federal requirement specific to the FDA’s PMA approval of this Class III device.”  In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200, 1207 (8th Cir. 2010).

But TwIqbal has defeated “laundry list” pleadings much more recently.  In Canary v. Medtronic, Inc., 2017 WL 1382298 (E.D. Mich. April 18, 2017), plaintiffs’ complaint recited “over the course of nine pages and nearly thirty paragraphs . . . a plethora of CGMPs and other regulatory provisions to which Defendant allegedly was subject.”  Id. at *8.  Nonetheless, the court TwIqballed the complaint.

A number of courts have rejected this “laundry list” approach to pleading a parallel claim arising from a manufacturer’s alleged violation of FDA regulations or CGMPs. . . .  [T]he allegations that follow Plaintiff’s lengthy recitation of purportedly relevant CGMPs and regulatory duties are too vague and conclusory to satisfy the Twombly/Iqbal standard of plausibility. . . .  [T]he allegations put forward by Plaintiff here in support of her product liability claims lack the factual content necessary to permit the plausible inferences (i) that Defendant violated one or more FDA regulations . . . and (ii) that Plaintiff was injured as a result of these violations.

Id. (citations omitted).

A similar result was reached in McLaughlin v. Bayer Corp., 172 F. Supp.3d 804 (E.D. Pa. 2016).  Five unrelated plaintiffs tried to gin up a parallel claim with a long list of purported regulatory violations, filing a single complaint that “simply include[d] a laundry list of over twenty-five federal ‘requirements,’” to which were appended “over twenty alleged breaches” – all “without giving any indication as to what federal requirement was violated by each alleged breach.”  Id. at 820-21.  TwIqbal barred that hot mess:

Most importantly . . . Plaintiffs have failed to allege any identifiable causal connection between the alleged [violations] and Plaintiffs’ resulting injuries. . . . The Complaint then baldly alleges that all identified . . . breaches caused Plaintiffs’ damages. . ., [but] [g]iven the lack of allegations that in any way link [defendant’s] failure to follow procedures . . . with . . . any of Plaintiffs’’ [] devices . . ., we can only conclude that Plaintiffs’ claims are based entirely on speculation.  Indeed, we are unable to discern any plausible and non-speculative causal connection between any of [defendant’s] alleged . . . failings and . . . Plaintiffs’ [] devices.  Accordingly, we conclude that the negligent risk management claim, as currently pled, does not set forth a plausible claim for relief.

172 F. Supp.3d at 821 (citations and quotation marks omitted).  A similar string of regulatory violation allegations got the bum’s rush in Gelber v. Stryker Corp., 788 F. Supp.2d 145 (S.D.N.Y. 2011), because, “[t]o the extent these vague and conclusory allegations are not impliedly preempted . . ., plaintiffs have failed to set forth facts to plausibly allege how defendants violated these provisions or how [injured plaintiff’s] injury is linked to any such violation.”  Id. at 164-65.

Likewise, in Raab v. Smith & Nephew, Inc., 150 F. Supp.3d 671 (S.D.W. Va. 2015), plaintiffs’ allegations of “wholesale noncompliance with the requirements of . . . a series of statutory provisions” failed TwIqbal.  Id. at 698.

[P]laintiffs do not allege how any of the defendant’s promotional activities violated federal law because they neither identify any specific conduct on the part of the defendant . . . nor any substantive federal regulation, restriction, or standard . . . actually made applicable to any of the defendant’s devices.  On such allegations, the defendant (and this Court) are left to guess as to the manner in which the defendant was negligent under state law.  More is required of a valid parallel claim.

Id. (citations omitted).  A similar “list[] without any supporting factual allegations eight provisions of the FDCA and corresponding federal regulations which Plaintiff’s allegedly violated” was TwIqballed in Gavin v. Medtronic, Inc., 2013 WL 3791612, at *16 (E.D. La. July 19, 2013), since “Plaintiff has failed to identify violations of federal regulations and provide allegations connecting those violations to Plaintiff’s specific injury.”  Id. at *17.

Parallel violation claims fail where “plaintiff cites generally applicable CGMPs and contends the [PMA device] violated them, without alleging specific facts to support his assertions.”  Gale v. Smith & Nephew, Inc., 2013 WL 9874422, at *3 (S.D.N.Y. Sept. 13, 2013).  In Shuker, the court denied plaintiff’s attempt to amend the complaint, due to woefully insufficient pleading:

In Count II of their Second Amended Complaint, Plaintiffs allege Defendants were negligent in that they breached their duty “to comply with the [FDCA] and the regulations promulgated pursuant to the Act” by violating a host of statutory and regulatory provisions.  Although defendants devote twenty pages − approximately one-third of the Second Amended Complaint − to cataloging these alleged violations, they offer no legal support for, or explanation of, most of the theories they seek to advance. . . .  As a result, the Court is left to parse a lengthy laundry list of FDCA provisions and FDA regulations.

2015 WL 1475368, at *13 (factual citations omitted).  The allegations failed because “Plaintiffs have not pleaded facts supporting a plausible inference that Defendants engaged in” the claimed violations, pleaded “conclusory allegation[s]” that were “entirely speculative,” and “provide[d] no explanation of any such deviation[s].”  Id. at *14, 16.

The same result occurred in Paturzo v. Boston Scientific Corp., 2017 WL 8220600 (C.D. Cal. April 21, 2017), where bald allegations of multiple regulatory violations could not save a supposed “parallel” claim from dismissal:

Although Plaintiffs list several federal regulations that Defendants purportedly violated, they fail to allege any facts relating the [device failure] to Defendants’ manufacturing processes and, specifically, the FDA’s requirements for manufacturing. Plaintiffs’ allegations of Defendants’ failure to establish or maintain certain quality control procedures are simply regurgitations of the text of the federal regulations.  Alone, they amount to no more than an allegation that Defendants violated federal standards.

Id. at *5.  The court could “draw no reasonable inference that the [device failure] was the result of a manufacturing defect, let alone that the manufacturing defect arises from Defendants’ failure to comply with FDA requirements. Id. Accord Chester v. Boston Scientific Corp., 2017 WL 751424, at *9 (D.N.J. Feb. 27, 2017) (complaint “provides a laundry list of FDA regulations with which Defendants were obligated to comply” but “is missing . . . any plausible pleading of if, how, or when Defendants violated any of the listed regulations”).

See also Skinner v. St. Jude Medical, Inc., 2016 WL 4054931, at *3 (W.D. La. July 27, 2016) (“it is difficult to discern whether any of [plaintiffs’] claims are parallel claims because the amended complaint contains little more than a laundry list of bare, conclusory allegations”); Nevolas v. Boston Scientific Corp., 2016 WL 1532259, at *3-4 (W.D. Okla. April 15, 2016) (5 paragraphs of violation allegations insufficient; “more is required to make out a parallel claim than conclusory statements that a defendant violated multiple regulations) (quoting Swisher, supra); Ward v. St. Jude Medical, Inc., 2016 WL 1208789, at *2 (S.D. Fla. March 28, 2016) (“Although the amended complaint alleges that the defendants violated various federal statues, it does not present device-specific premarket violations linked to the plaintiffs’ alleged harm.”); Ellis v. Smith & Nephew, Inc., 2016 WL 7319397, at *4-5 (D.S.C. Feb. 16, 2016) (list of 12 alleged violations “failed to allege how the violations of these federal requirements would give rise to liability under state law for [plaintiff’s] injuries”); Grant, 2016 WL 4447523, at *6 (complaint “is utterly devoid of factual allegations concerning what manufacturing procedures Defendants allegedly violated”); Nevolas v. Boston Scientific Corp., 2016 WL 347721, at *3 (W.D. Okla. Jan. 28, 2016) (complaint “simply makes numerous conclusory allegations, devoid of any factual support, that defendant violated in unspecified ways various federal regulations and federal manufacturing requirements”); Thibodeau v. Cochlear Ltd., 2014 WL 3700868, at *4 (D. Ariz. July 25, 2014) (“negligence claims cannot simply put forth a laundry list of PMA or federal law provisions Defendants failed to follow without some factual allegations in support”); Williamston v. Medtronic, Inc., 2014 WL 2042004, at *7 (W.D. La. May 15, 2014) (footnote omitted) (“[t]he simple listing of various federal regulations is insufficient to successfully plead a state law claim predicated on the violation of federal requirements”); McPhee v. DePuy Orthopedics, Inc., 2013 WL 5462762, at *5 (W.D. Pa. Sept. 30, 2013) (“Plaintiffs merely list the CFR provisions and assert that Defendant was negligent in violating the listed provisions”); Desai v. Sorin CRM USA, Inc., 2013 WL 163298, at *6-7 (D.N.J. Jan. 15, 2013) (list of regulations “fail[s] to assert the facts necessary, or indeed, any facts at all, to establish a claim that would parallel a violation of federal law” and “fail[s] to allege any ‘cognizable link’ between [the] alleged federal violations and [plaintiff’s] injury”); Cohen v. Guidant Corp., 2011 WL 637472, at *2 (C.D. Cal. Feb. 15, 2011) (complaint was “flawed . . . because it lists boilerplate FDA regulations without linking any of those regulations to a defect in [plaintiff’s] specific pacemaker that was caused by Defendants violating FDA regulations”); Cenac v. Hubbell, 2010 WL 11537934, at *2-3 (E.D. La. April 16, 2010) (list of four regulatory violations in complaint TwIqballed “because it provides no facts with respect to how [defendant] violated federal regulations”).

In Weaver v. Ethicon, Inc., 2016 WL 7098781 (S.D. Cal. Dec. 6, 2016), plaintiffs tried to cobble together a failure-to-report claim from an allegation that defendant violated no less than fourteen FDA regulations. Id. at *5 (listing regulations).  This “laundry list” failed because “[a] general allegation that Defendant failed to report adverse events to the FDA is not sufficient to demonstrate causation.”  Id. at *6 (citations omitted).  Plaintiffs’ “acts present only conclusory allegations that Defendant failed to report adverse events without specific instances of actual adverse events.”  Id.  For a comprehensive rundown (as of September, 2016) of causation issues in failure-to-report cases, see this prior post.

A fortiori, the minimalist approach the pleading FDCA violations also fails.  Plaintiffs “cannot simply incant the magic words ‘[defendant] violated FDA regulations’ in order to avoid preemption.”  Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011).  “[B]road references to federal regulations in pleadings are insufficient.”  Gross, 858 F. Supp.2d 466, 494 (W.D. Pa. 2012).

Although Plaintiff acknowledges that [defendant] must comply with the specific regulations that apply to the . . . PMA device, he does not outline what these regulations are or how [defendant] allegedly violated same.  Because Plaintiff pled his negligence claim in a very general manner, he has failed to state a claim for negligence that survives preemption.

Id. at 497 (citation omitted).  In Olmstead v. Bayer Corp., 2017 WL 3498696 (N.D.N.Y. Aug. 15, 2017), the plaintiff alleged generally that the defendant violated the FDA’s CGMPs, citing generally, “21 C.F.R. §820.1 et. seq.”  But “[p]laintiff fail[ed] to explain how Defendants violated the CGMPs.”  Id. at *4.  That attempt resulted in dismissal because:

Plaintiff has failed to identify a single parallel federal statute or regulation related to any of her claims.  Therefore, the Court concludes that, as a matter of law, the MDA expressly preempts Plaintiff’s claims.

Id. (footnote omitted). See also Ali v. Allergan USA, Inc., 2012 WL 3692396, at *7 (E.D. Va. Aug. 23, 2012) (plaintiff’s “Complaint offers a series of conclusory allegations that that [defendant] violated federal law in the manufacture and marketing of the [device].  However, without factual enhancement, these statements are insufficient to plead plausible federal violations”); Parker v. Stryker Corp., 584 F. Supp. 2d 1298, 1302 (D. Colo. 2008) (“nowhere does plaintiff’s complaint provide any factual detail to substantiate that crucial allegation”).

Thus, although on first glance a complaint’s multi-paragraph list of FDA regulations that the defendant allegedly violated may look imposing, chances are that the plaintiff has failed either to plead facts sufficient to establish any violation as to the particular device or to allege how the purported violations caused a product defect that actually caused the injuries being alleged.  In either instance, the plaintiff’s “parallel” claim preemption dodge should properly be TwIqballed.

It’s been a while since we’ve discussed pre-service removal, other than to mention a recent case.  Our last major post was “What’s up with Removal Before Service,” back in May 2011.

Since then, we pointed out an important statutory development – that when Congress rewrote other parts of the removal statute (28 U.S.C. §1441(b)) in 2011, it left intact the language that, read according to its terms (often referred to as “plain meaning” in the cases), allows pre-service removal.  That’s important, because the major argument against pre-service removal is that it’s “gamesmanship” (as if joining 99 disparate plaintiffs in a single complaint isn’t) that leads to “absurd” results that Congress could not have intended.  “However, one person’s ‘gamesmanship’ is strategy to another.” Francis v. Great West Casualty Co., 2018 WL 999679, at *2 (M.D. Ga. Feb. 21, 2018).

[F]rom a policy perspective, §1441(b) protects non-forum defendants from plaintiffs’ procedural maneuvering to deprive these defendants of their statutory right to litigate in a federal forum. . . . This protection . . . is particularly important because the forum defendant rule creates an opportunity for procedural gamesmanship on the part of plaintiffs attempting to keep an action in state court, and thus blocking removal, by either improperly joining a forum defendant, or not serving the forum defendant that they have no intention of pursuing.

In Re Plavix Products Liability & Marketing Litigation, 2014 WL 4954654, at *6 (D.N.J. Oct. 1, 2014) (citations omitted).

That Congress, knowing full well that pre-service removal was being routinely practiced, elected to leave intact the statutory language enabling pre-service removal, makes the “absurdity” argument a much harder sell.  After all, if the statute’s language permits too much “gamesmanship,” the proper response is for Congress to amend the statute, as it did back in 1948 when the “properly joined and served” language was first added.  See Goodwin v. Reynolds, 757 F.3d 1216, 1220-21 (11th Cir. 2014) (discussing 1948 amendment).  It is not the courts’ role to usurp Congress by making ad hoc modifications of statutory language, whenever judges feel like it, particularly when Congress had the opportunity to amend the statute again in 2011, but declined to do so.

[U]nder the plain meaning of §1441(b) an out-of-state defendant, by monitoring state court dockets electronically or otherwise, can dash to the federal courthouse almost immediately with a notice of removal before the complaint is served on it and on an in-state defendant.  As a consequence of advances in technology, there may well be fewer diversity actions precluded from removal under §1441(b) than heretofore.  If this result is deemed to be bad public policy, the remedy lies with Congress which, subject to constitutional limitations, controls the scope of this court’s subject matter jurisdiction and any right of removal.

Valido-Shade v. Wyeth, LLC, 875 F. Supp.2d 474, 478 (E.D. Pa. 2012), summarily aff’d, No. 14-4608 (3d Cir. April 29, 2015).

Enough ranting (for now).  In any event, since our “What’s up” post, we’ve also written several individual posts about:

Christison v. Biogen Idec, Inc., 2011 WL 13153242 (N.D. Cal. Nov. 14, 2011)

Poznanovich v. AstraZeneca Pharmaceuticals LP, 2011 WL 6180026 (D.N.J. Dec. 12, 2011)

Boyer v. Wyeth Pharmaceuticals, Inc., 2012 WL 1449246 (E.D. Pa. April 26, 2011)

Davis v. Hoffmann-La Roche, 2014 WL 12647769 (Mag. N.D. Cal. Jan. 14, 2014), adopted, 2014 WL 12647768 (N.D. Cal. Jan. 31, 2014)

Young v. Bristol-Myers Squibb Co., 2017 WL 2774735 (D. Del. June 27, 2017)

Cheung v. Bristol-Myers Squibb Co., 282 F. Supp.3d 638 (S.D.N.Y. 2017)

So, that’s six additional pre-service removal cases from five states since our last comprehensive post in 2011.  Let’s see how many more there are out there that we’ve missed.

The first thing we note is that some appellate authority now exists.  Since remand is unappealable (28 U.S.C. §1447(d)), appellate review is rare in remand situations.  Most recently, in Bank of New York Mellon v. Mazza, ___ F. Appx. ___, 2018 WL 3524899 (3d Cir. July 23, 2018), the court observed (albeit refraining from deciding the issue) “that every Court of Appeals to have addressed the issue has concluded that defendants in state-court actions may indeed remove them before being served with process.”  Id. at *2.  Mazza cited Novak v. Bank of N.Y. Mellon Trust Co., 783 F.3d 910, 914 (1st Cir. 2015); La Russo v. St. George’s University School, 747 F.3d 90, 97 (2d Cir. 2014), and Delgado v. Shell Oil Co., 231 F.3d 165, 177 (5th Cir. 2000).

Delgado, of course, is from the antediluvian period before modern, technologically-aided pre-service removal, but the Fifth Circuit did state unequivocally that “service of process is not an absolute prerequisite to removal.”  231 F.3d at 177.  Rather, the language of §1441(b) “consciously reflect[s] a desire on the part of Congress to require than an action be commenced against a defendant before removal, but not that the defendant have been served.”  Id.  See also McCall v. Scott, 239 F.3d 808, 813 n.2 (6th Cir. 2001) (“Where there is complete diversity of citizenship . . . inclusion of an unserved resident defendant in the action does not defeat removal under 28 U.S.C. §1441(b).”).

Delgado was also cited in La Russo, where the Second Circuit held:

The argument lacks merit.  Nothing in sections 1441 or 1446 requires a removing defendant to have appeared in the state court proceeding prior to removal.  Nor is there merit in [plaintiff’s] claim that removal was improper because [a defendant] was not served.  Service of process upon a removing defendant is not a prerequisite to removal.

747 F.3d at 97 (citing not only Delgado, but also City of Ann Arbor Employees’ Retirement System v. Gecht, 2007 WL 760568, at *9 (N.D. Cal. March 9, 2007) – a modern pre-service removal case rejecting the “absurd results” argument).

Delgado was also cited in Novak, which is an even more powerful embrace of pre-service removal.  First, the First Circuit stated:

[W]e think it is clear that a defendant generally need not wait until formal receipt of service to remove.  There is no indication that . . . Congress intended to prohibit a defendant from filing a notice of removal before having been formally served

7893 F.3d at 912. A few pages later, Novak held:

[We find] no indication that a defendant was also prohibited from filing a notice of removal before service. We read the statute to contemplate otherwise.  Our interpretation thus aligns with the decisions of other federal courts that have considered this question. . . .  As far as we can tell, every one has concluded that formal service is not generally required before a defendant may file a notice of removal.  And, because Congress is presumed to be aware of an administrative or judicial interpretation of a statute and to adopt that interpretation when it re-enacts a statute without change, we find it informative that Congress made no effort to cast aside this clear consensus among federal courts when it amended §1446 in 2011 without making any substantive change to subsection (b)(1)

Id. at 914 (citations and quotation marks omitted).  In addition to Delgado and LaRusso, Novak added Whitehurst v. Wal-Mart, 306 F. Appx. 446, 448 (11th Cir. 2008) (“nothing in the removal statute, or any other legal provision, requires that a defendant be served with the complaint before filing a notice of removal”), and Sutler v. Redland Insurance Co., 2012 WL 5240124, at *2 (D. Mass. Oct. 24, 2012), another district court case recognizing pre-service removal.  With Court of Appeals decisions now breaking in our favor, we can start trying to change the minds of district courts that have previously gone the other way.

Also, since our 2011 post − although not in a pre-service removal situation − the Seventh Circuit in Morris v. Nuzzo, 718 F.3d 660 (7th Cir. 2013), helpfully noted that the “properly joined and served” language in §1446(b) creates “a service-based exception to the forum defendant rule, meaning that a properly served out-of-state defendant will not be prevented from removing a case when the plaintiff has named but not yet served a resident defendant.”  Id. at 670 n. 3.

As far as the district courts go, here is what we now have – in addition to what we found back in our 2011 post (we did miss some back then, which we’re backfilling now).  As always, we do not do the other side’s research for them, so what follows are all cases allowing pre-service removal – except for those cases we listed back in 2011:

Alabama

Seong Ho Hwang v. Gladden, 2016 WL 9334726, at *5-7 (M.D. Ala. Dec. 21, 2016); Sasser v. Florida Pond Trucking, L.L.C., 2016 WL 3774125, at *4-5 (Mag. M.D. Ala. June 24, 2016), adopted, 2016 WL 3769754 (M.D. Ala. July 14, 2016); Pathmanathan v. Jackson National Life Insurance Co., 2015 WL 4605757, at *3-5 (M.D. Ala. July 30, 2015); Goodwin v. Reynolds, 2012 WL 4732215, at *3-6 (N.D. Ala. Sept. 28, 2012), aff’d on other grounds, 757 F.3d 1216 (11th Cir. 2014); Lemley v. Midwest Automation, Inc., 2009 WL 1211382, at *1 & n.2 (S.D. Ala. May 1, 2009).

Alaska

Seeds v. ERA Alaska, 2013 WL 11311389, at *3 (D. Alaska Nov. 4, 2013).

California

Saratoga Advantage Trust Technology & Communications Portfolio v. Marvell Technology Group, Ltd., 2015 WL 9269166, at *2 (N.D. Cal. Dec. 21, 2015); Sherman v. Haynes & Boone, 2014 WL 4211118, at *1 (N.D. Cal. Aug. 22, 2014); Wilder v. Bank of America, N.A., 2014 WL 12591934, at *4 (C.D. Cal. June 30, 2014); Davis v. Hoffmann-La Roche, 2014 WL 12647769, at *2 (Mag. N.D. Cal. Jan. 14, 2014), adopted, 2014 WL 12647768 (N.D. Cal. Jan. 31, 2014); Fontalvo v. Sikorsky Aircraft Corp., 2013 WL 3197071, at *9-10 (S.D. Cal. June 20, 2013); Regal Stone Ltd. v. Longs Drug Stores California, L.L.C., 881 F. Supp.2d 1123, 1127-29 (N.D. Cal. 2012); May v. Haas, 2012 WL 4961235, at *2-2 (E.D. Cal. Oct. 16, 2012); Christison v. Biogen Idec, Inc., 2011 WL 13153242, at *1 (N.D. Cal. Nov. 14, 2011); Cucci v. Edwards, 510 F. Supp.2d 479, 482-84 (C.D. Cal. 2007); Waldon v. Novartis Pharmaceuticals Corp., 2007 WL 1747128, at *2-3 (N.D. Cal. June 18, 2007); City of Ann Arbor Employee’s Retirement System v. Gecht, 2007 WL 760568, at *8-9 (N.D. Cal. March 9, 2007).

Delaware

Young v. Bristol-Myers Squibb Co., 2017 WL 2774735, at *2 (D. Del. June 27, 2017); Munchel v. Wyeth LLC, 2012 WL 4050072, at *3-4 (D. Del. Sept. 11, 2012); Hutchins v. Bayer Corp., 2009 WL 192468, at *10-11 (Mag. D. Del. Jan. 23, 2009).

District of Columbia

Middlebrooks v. Godwin Corp., 279 F.R.D. 8, 11-12 (D.D.C. 2011).

Florida

Bergmann v. State Farm Mutual Automobile Insurance Co., 2016 WL 9414108, at *2 (N.D. Fla. Dec. 28, 2016); ViSalus, Inc. v. Then, 2013 WL 3682239, at *3 (M.D. Fla. July 12, 2013); Visalus, Inc. v. Knox, 2013 WL 3462176, at *1-2 (M.D. Fla. July 9, 2013); North v. Precision Airmotive Corp., 600 F. Supp.2d 1263, 1268-70 (M.D. Fla. 2009); Valerio v. SmithKline Beecham Corp., 2008 WL 3286976, at *2 (S.D. Fla. Aug. 7, 2008); Bolin v. SmithKline Beecham Corp., 2008 WL 3286973, at *2 (S.D. Fla. Aug. 7, 2008); Masterson v. Apotex, Corp., 2008 WL 2047979, at *2 (S.D. Fla. May 13, 2008).

Georgia

Francis v. Great West Casualty Co., 2018 WL 999679, at *2 (M.D. Ga. Feb. 21, 2018); McClain v. Bank of America Corp., 2013 WL 1399309, at *3 (S.D. Ga. April 5, 2013).

Illinois

D.C. v. Abbott Laboratories Inc., 2018 WL 4095093, at *3-5 (N.D. Ill. Aug. 28, 2018); Graff v. Leslie Hindman Auctioneers, Inc., 299 F. Supp.3d 928, 934-37 (N.D. Ill. 2017); Selective Insurance Co. v. Target Corp., 2013 WL 12205696, at *1 (N.D. Ill. Dec. 13, 2013); In re Pradaxa (Dabigatran Etexilate) Products Liability Litigation, 2013 WL 656822, at *3-4 (S.D. Ill. Feb. 22, 2013); Massey v. Cassens & Sons, Inc., 2006 WL 381943, at *2-3 (S.D. Ill. Feb. 16, 2006).

Indiana

In re Bridgestone/Firestone, Inc., 184 F. Supp.2d 826, 828 (S.D. Ind. 2002).

Kentucky

United Steel Supply, LLC v. Buller, 2013 WL 3790913, at 1-2 (W.D. Ky. July 19, 2013); Darsie v. Cone, 2010 WL 2923285, at *5 (E.D. Ky. July 22, 2010); Stanley v. Insights Training Group, LLC, 2009 WL 3514590, at *1-2 (W.D. Ky. Oct. 29, 2009).

Louisiana

Lewis-Wallace v. Johnson, 2018 WL 1531921, at *2 (E.D. La. March 29, 2018); Leech v. 3M Co., 278 F. Supp.3d 933, 941-43 (E.D. La. 2017); Sexton v. Exxon Mobil Corp., 2017 WL 6803443, at *2 (Mag. M.D. La. Sept. 15, 2017), adopted, 2018 WL 283259 (M.D. La. Jan. 3, 2018); Mendoza v. JLG Industries, Inc., 2016 WL 6872107, at *2 (E.D. La. Nov. 22, 2016); Gorman v. Schiele, 2016 WL 3583645, at *2-3 (Mag. M.D. La. June 8, 2016), adopted, 2016 WL 3580669 (M.D. La. June 28, 2016); Gorman v. Schiele, 2016 WL 3583640, at *5-6 (Mag. M.D. La. May 20, 2016), adopted, 2016 WL 3580669 (M.D. La. June 28, 2016); Colletti v. Bendix, 2016 WL 770646, at *2 (E.D. La. Feb. 29, 2016); Williams v. Boyd Racing LLC, 2016 WL 236993, at *3 (W.D. La. Jan. 19, 2016); Groves v. Farthing, 2015 WL 3646724, at *4-5 (E.D. La. June 10, 2015); Harvey v. Shelter Insurance Co., 2013 WL 1768658, at *2 (E.D. La. April 24, 2013).

Maryland

Al-Ameri v. Johns Hopkins Hospital, 2015 WL 13738588, at *1-2 (D. Md. June 24, 2015); Moore v. Svehlak, 2013 WL 3683838, at *15 (D. Md. July 11, 2013); Clawson v. FedEx Ground Package System, Inc., 451 F. Supp.2d 731, 736 (D. Md. 2006).

Massachusetts

Sutler v. Redland Insurance Co., 2012 WL 5240124, at *2 (D. Mass. Oct. 24, 2012).

Michigan

Gordon v. Home Loan Center, LLC, 2011 WL 1261179, at *7 (E.D. Mich. March 31, 2011); Revere v. MERS, 2010 WL 1541506, at *2 (E.D. Mich. April 19, 2010).

Mississippi

Holmes v. Lafayette, , 2013 WL 654449, at *1 (N.D. Miss. Feb. 21, 2013); Ott v. Consolidated Freightways Corp., 213 F. Supp.2d 662, 665-66 (S.D. Miss. 2002).

Missouri

Gray v. Monsanto Co., 2018 WL 488935, at *2 (E.D. Mo. Jan. 19, 2018); Travers v. Five Below, Inc., 2017 WL 2813320, at *2-3 (E.D. Mo. June 29, 2017); Johnson v. Emerson Electric Co., 2013 WL 5442752, at *4 (E.D. Mo. Sept. 30, 2013); Taylor v. Cottrell, Inc., 2009 WL 1657427, at *2 (E.D. Mo. June 10, 2009); Brake v. Reser’s Fine Foods, Inc., 2009 WL 213013, at *2-3 (E.D. Mo. Jan. 28, 2009); Johnson v. Precision Airmotive, LLC, 2007 WL 4289656 at *6 (E.D. Mo. Dec. 4, 2007).

Montana

Mahana v. Enerplus Resources U.S.A. Corp., 2012 WL 1947101, at *2-3 (Mag. D. Mont. May 30, 2012), adopted, 2012 WL 4748178, at *1 (D. Mont. Oct. 4, 2012).

New Jersey

In Re Plavix Products Liability & Marketing Litigation, 2014 WL 4954654, at *4-6 (D.N.J. Oct. 1, 2014); Westfield Insurance Co. v. Interline Brands, Inc., 2013 WL 1288194, at *2-4 (D.N.J. March 25, 2013) Poznanovich v. AstraZeneca Pharmaceuticals LP, 2011 WL 6180026, at *3-5 (D.N.J. Dec. 12, 2011); Jaeger v. Schering Corp., 2007 WL 3170125, at *2 (D.N.J. Oct. 25, 2007); Yocham v. Novartis Pharmaceuticals Corp., 2007 WL 2318493 at *3 (D.N.J. Aug. 13, 2007); Frick v. Novartis Pharmaceuticals Corp., 2006 WL 454360, at *3 (D.N.J. Feb. 23, 2006).

New York

Cheung v. Bristol-Myers Squibb Co., 282 F. Supp.3d 638, 643-44 (S.D.N.Y. 2017); Petit v. Bristol-Myers Squibb Co., 2012 WL 11893525, at *1-2 (S.D.N.Y. March 23, 2012); Stop & Shop Supermarket Company LLC v. Goldsmith, 2011 WL 1236121, at *6 (S.D.N.Y. March 31, 2011); Deveer v. Gov’t Employees Insurance Co., 2008 WL 4443260, at *4 (E.D.N.Y. Sept. 26, 2008); In re Fosamax Products Liability Litigation, 2008 WL 2940560, at *2, 5 (S.D.N.Y. July 29, 2008).

Oklahoma

Howard v. Crossland Construction Co., 2018 WL 2463099, at *2 (N.D. Okla. June 1, 2018); Magallan v. Zurich American Insurance Co., 228 F. Supp.3d 1257, 1260-62 (N.D. Okla. 2017).

Pennsylvania

Rehmeyer v. Peake Plastics Corp., 2016 WL 7375027, at *3 (E.D. Pa. Dec. 20, 2016); Figured v. Davies, 2016 WL 3148392, at *3 (M.D. Pa. June 2, 2016); Parker Hannifin Corp. v. Federal Insurance Co., 23 F. Supp. 3d 588, 594 (W.D. Pa. 2014); Hutton v. KDM Transport, Inc., 2014 WL 3353237, at *4 (E.D. Pa. July 9, 2014); Valido-Shade v. Wyeth, LLC,, 875 F. Supp.2d 474, 477-78 (E.D. Pa. 2012), summarily aff’d, No. 14-4608 (3d Cir. April 29, 2015); Zokaites Properties, LP v. La Mesa Racing, LLC, 2012 WL 3144127, at *17 (W.D. Pa. Aug. 1, 2012); Banks v. Kmart Corp., 2012 WL 707025, at *2 (E.D. Pa. March 6, 2012); Boyer v. Wyeth Pharmaceuticals, Inc., 2012 WL 1449246, at *2 (E.D. Pa. April 26, 2011); Copley v. Wyeth, Inc., 2009 WL 1089663, at *3 (E.D. Pa. April 22, 2009); Vanderwerf v. Glaxosmithkline, PLC, 2005 WL 6151369, at *1 (E.D. Pa. May 5, 2005).

South Carolina

Fisher v. Pelstring, 2009 WL 10664813, at *2-4 (D.S.C. Sept. 29, 2009).

Tennessee

Linder v. Medtronic, Inc., 2013 WL 5486770, at *1-2 (W.D. Tenn. Sept. 30, 2013).

Texas

Cadena v. ASI Lloyds, 2018 WL 1904839, at *3 (Mag. W.D. Tex. Jan. 5, 2018), adopted, 2018 WL 1899750 (W.D. Tex. Feb. 13, 2018); Doe v. Geo Group, Inc., 2016 WL 3004675, at *3 (W.D. Tex. May 24, 2016); Reynolds v. Personal Representative of the Estate of Johnson, 139 F. Supp.3d 838, 841-43 (W.D. Tex. 2015); Breitweiser v. Chesapeake Energy Corp., 2015 WL 6322625, at *4-7 (N.D. Tex. Oct. 20, 2015); Rios v. Cooper Tire & Rubber Co., 2014 WL 12613385, at *3 (E.D. Tex. March 26, 2014); Carrs v. AVCO Corp., 2012 WL 1945629, at *1-3 (N.D. Tex. May 30, 2012).

West Virginia

Bloom v. Library Corp., 112 F. Supp.3d 498, 506 (N.D.W. Va. 2015); Konikowski v. Wheeling Island Gaming, Inc., 2012 WL 5378252, at *4 (N.D.W. Va. Oct. 31, 2012); Vitatoe v. Mylan Pharmaceuticals, Inc., 2008 WL 3540462, at *2-5 (N.D.W. Va. Aug. 13, 2008).

*          *          *          *

Finally, while not doing the plaintiffs’ research for them, we can safely state, after reading the “absurd result” cases, that the most dangerous form of pre-service removal is by a forum defendant alone, or equivalently, in a case where only forum defendants are sued.  That’s widely seen as a direct slap at the forum defendant rule.  The next most dangerous removals are those taken by forum defendants in cases where there are also non-resident defendants.  The most sympathetic pre-service removal scenario is when the removal is initiated by a non-resident defendant – the type of party that diversity jurisdiction was originally intended to protect.  When defendants have a choice, therefore, it would be best to let the non-resident defendant carry the flag in pre-service removal cases.

One can also hope that current trends in personal jurisdiction might result in dismissal in cases where defendants previously sought to rely upon pre-service removal, since jurisdiction over one affiliated, but separate, “forum defendant” corporation no longer translates into jurisdiction over other corporate defendants.  If, as occurs often in mass tort cases, the plaintiff is also a non-resident of the jurisdiction where suit is brought, then the plaintiff may well not be able to obtain jurisdiction over the non-resident corporate defendant.

Nothing emphasizes the impermanence of just about everything as Hawaii – where Bexis is right now on vacation.  On Kauai, Bexis had a boat drop scheduled to Kalalalu Beach, for three days on the Kalalau Trail, all permits obtained.  But several months ago, the heavens opened, and the Na Pali Coast received over an inch of rain an hour for more than a day.  A large number of avalanches, floods, and sinkholes ensued.  The road washed out in numerous places, as (more importantly) did people’s homes – so the best trail in Kauai is closed indefinitely.

That’s not even the worst of it. At least there are plans (on Hawaiian time) to reopen both the road and the trail.  But our favorite resort on the Big Island has been closed for several years.  The Kona Village Resort was damaged by the same 2011 tsunami caused all that horrible destruction in Japan.  For almost a decade, it has been abandoned on the shore at Kaupulehu tied up in layers of debt and litigation.  Although now there’s a rumor that it might reopen in 2019 – we’ve seen those before, so we’ll believe it when we see it.

But even that’s not the worst of it.  Our last trip to the Big Island, we swam in some lovely naturally heated tide pools.  We won’t be able to do that again.  They’re now covered by hundreds of feet of lava from the “Fissure 8” eruption that started on May 2, 2018.  In a geologically active area such as Hawaii, even the land itself is impermanent.

Impermanence is also a legal phenomenon.   Long-time readers of the blog may recall a series of posts from the Mark Herrmann era describing how the two of us fought an ultimately losing battle during the American Law Institute’s Aggregate Litigation Principles Project to keep the ALI from endorsing the practice of “cy pres.”  Not-so-long-time readers might be wondering, “what the heck is that?”  Here’s our description of cy pres from an earlier post:

For those of you new to all this, “cy pres” is the name given to schemes – virtually exclusively in class actions – whereby courts take money supposedly belonging to class members that class counsel can’t or won’t (due to expense) identify and give it to non-class members (mostly charities) who were not damaged in any way by the claimed conduct of the defendants. We know of no legal power invested in the judiciary to take money away from supposedly injured litigants and give it to persons who are essentially bystanders.  There are methods of doing this.  When done privately, it’s called “theft.”  Publicly, it would involve the powers to tax, appropriate, and levy fines, which belong to branches of government other than the judiciary.  We further believe that use of cy pres to facilitate class actions violates the Rules Enabling Act, since procedural rules (such as Rule 23) can’t change the substantive law.  There’s not much more “substantive” than taking money supposedly belonging to injured litigants and giving it to non-parties.

The result was Principles of Aggregate Litigation §3.07 (ALI 2010), entitled “Cy Pres Settlements,” which seemed to enshrine into black-letter law the doctrine that it’s OK to give away purported class members’ money to whatever charity the judge and the lawyers decide to favor.

We kept up a rear-guard battle against cy pres, however, helping draft a proposal for Lawyers for Civil Justice to amend Fed. R. Civ. P. 23 to abolish cy pres. That was a long shot, since the very judges whose power cy pres augmented would have to approve such a change.  Also, were heartened by Chief Justice Roberts’ concurring opinion in Marek v. Lane, 134 S.Ct. 8 (2013), suggesting that the Supreme Court might also have concerns about this peculiar institution.

Then, last May, the Supreme Court granted certiorari in a case we had previously described as a “poster child” for cy pres abuse.  In re Google Referrer Header Privacy Litigation, 869 F.3d 737 (9th Cir. 2017).  This appeal, now called Frank v. Gaos, No. 17-961, 138 S. Ct. 169 (April 30, 2018), features just about everything we don’t like about cy pres:

  • Excessive counsel fees – class counsel stands to walk away with fully 38% of the settlement as fees.  869 F.3d at 747.
  • Lack of classwide recovery – the court declared the entire settlement “non-distributable” because, even without opposition, neither the class members nor their damages could be determined.  Id. at 742.
  • Excessive cy pres – nothing is more excessive than 100% − six uninjured charities took 100% of what class counsel left behind, and the 129 million supposedly injured class members took nothing.  Id. at 743.
  • Rampant conflict of interest − Three of the charities were law schools – and they all had ties to counsel in the case.
  • Litigation industry self-perpetuation – cy pres recipients were expected solicit more lawsuits by “educat[ing]” the public and “publiciz[ing]” privacy issues.  Id. at 746-47.

By now, with briefing completed, we thought we’d take a look at the arguments that are being made to the Supreme Court in opposition to the use of cy pres class action settlements.

First and foremost is the petitioner’s brief, filed by friend-of-the-blog Ted Frank.  As we expected, he pulls no punches about the impropriety of a procedure that we’ve said amounts to judicially sanctioned theft.  The brief starts off by describing cy pres as “one of the most notorious devices used to create the illusion of compensation.”  Id. at 2.  “All the money went to class counsel and to favored nonprofit organizations affiliated with class counsel and the defendant.”  Id.  Petitioner seeks (pp. 15-16) five cy pres-related holdings from the Court:

  1. A settlement that compromises a class’s claims, but seeks to pay class counsel an amount disproportionate with the actual and direct benefit to the class, is not fair or reasonable under Rule 23(e).

Here, the fundamental fact of Due Process is, that “settlement-fund proceeds, having been generated by the value of the class members’ claims, belong solely to the class members.”  Neither courts nor counsel can “divert that property to third parties.”  Id. at 17.

All that courts need to accomplish this result is to apply a simple principle to the Rule 23 fairness hearing: regardless of whether a settlement is “adequate,” it is not fair or reasonable if the settlement pays attorneys’ fees that are disproportionate to the actual and direct benefit realized by the class compromising its claims.

Id. at 21.  Cy pres provisions are a means to “structure the deal to obfuscate the true [a]llocation . . . by larding the [settlement] analysis with hypothetical class recoveries and amorphous ‘benefits’ that ultimately have little value to the class.”  Id. at 23.

First, basing a fee award solely on the “size of the cy pres fund” allows “class attorneys . . . to reap exorbitant fees regardless of whether the absent class members are adequately compensated.”  Id. at 28.  Second, cy pres is “an enticing settlement feature for lawyers interested in promoting their own personal political or charitable preferences.”  Id. at 29.  The brief contains several examples of such conduct.  Id. at 29-30.  Second, with “no resistance from class attorneys,” defendants can even use cy to “benefit themselves” by directing funds to their preferred charities.  Id. at 30.  Again, several concrete examples are discussed.  Id. at 30-33.  Third, cy pres awards to non-parties “fail to redress class members’ alleged injuries for which they are waiving their rights.”  Id. at 33.  Here, another of our primary gripes comes into play.  “Rule 23 cannot operate to ‘abridge, enlarge or modify any substantive right,’” id., but altering who owns what is as “substantive” an application as we can think of.  More examples.  Id. at 33-35.  Fourth, cy pres “permit[s] otherwise unthinkable class certifications” and “induce[s] plaintiffs to pursue doubtful class claims” because they can settle without proving causation or damages. Id. at 35.

[C]y pres incentivizes both the bringing of otherwise unprofitable “strike suits” that would be infeasible to litigate due to unmanageability or questionable merit and their settlement on terms mutually agreeable to class counsel and the defendant.

Id.  A “class action that yields fees for class counsel and nothing for the class − is no better than a racket.” Id. at 36 (quoting In re Walgreen Co. Stockholder Litigation, 832 F.3d 718, 724 (7th Cir. 2016)).  Fifth, cy pres results in subsidizing the “political . . . preferences of class counsel or the defendant without regard to the views of “a substantial proportion, or even a majority, of class members.

Requiring class members to surrender their rights to subsidize speech by a third party that he or she does not wish to support raises serious First Amendment concerns.

Id. at 36.  If a union can’t even collect dues from its own members because of their First Amendment rights, see Janus v. AFSME, Council 31, 138 S. Ct. 2448, 2478 (2018) (“draw[ing] the line at . . .requir[ing] all employees to support the union irrespective of whether they share its views”), how can a court impose a charitable donation on unknown class members?  Sixth, cy pres “often create the appearance or reality of judicial conflicts of interest.”  Id. at 37.  “[A]n open-ended cy pres doctrine is fundamentally incompatible with the judicial role” of “providing relief to claimants . . . who have suffered, or will imminently suffer, actual harm.”  Id. at 38.

Petitioner also argues that all-cy-pres settlements simply cannot be approved under Rule 23:

Any settlement, like this one, that provides no direct benefit to the class, cannot be approved.  “Because the settlement yields fees for class counsel and zero benefits for the class, the class should not have been certified and the settlement should not have been approved.”

Id. at 39 (quoting In re Subway Footlong Sandwich Marketing Litigation, 869 F.3d 551, 557 (7th Cir. 2017)).  We would go further, since we don’t think any cy pres settlements should be approved.  Indeed, the existence of a cy pres component is an admission that, even with no legal opposition, plaintiffs are unable to prove causation or damages.  Such suits should not be brought.  We have criminal prosecutors and other governmental entities to handle such cases.  “[N]early every consumer class-action settlement leaves over 90%, and often over 99%, of the class uncompensated.”  Id. at 45.  We don’t need civil lawyers who are perversely incentivized through cy pres to do as little work as they can possibly get away with.

  1. Cy pres awards are inappropriate in class-action settlements where it is feasible to distribute settlement proceeds to class members.  Whether it is feasible to distribute settlement proceeds is determined by whether such relief can be distributed to some identifiable class members . . .  and not whether the proceeds could be distributed to every potential class member.

Plaintiffs, who have resolutely opposed any ascertainability prerequisite to class certification, do a backflip when it comes to cy pres and settlement.  “Under the standard set by the Ninth Circuit, it is not considered ‘feasible’ to provide any compensation to class members when it would be infeasible to compensate all of them.”  Petitioner’s br. at 49 (emphasis original).  This is using ascertainability to prevent compensation of class members.  “[I]t is nearly always feasible to distribute settlement funds to some class members.”  Id. at 50 (emphasis original).  “[C]y pres distribution when distribution to some of the class is possible is ‘contrary to the interests’ of the class.”  Id. at 51 (quoting In re BankAmerica Corp. Securities Litigation, 775 F.3d 1060, 1068 (8th Cir. 2015)).  Using cy pres to take money from any class members when some are identifiable thus violates class counsel’s “fiduciary duty to class members.”  Id. at 50-51.

  1. If a class-action settlement cannot provide direct relief to the class, the settlement class cannot be certified.

Again, we agree, even though we might go further.  If “it is somehow impossible to make any distribution to the class, that simply suggests that it was error to certify this settlement class.”  Petitioner’s br. at 52.

In short, the class action is not “superior to other available methods for fairly and efficiently adjudicating the controversy” because every single class member is worse off than if they opted out and reserved their claims to litigate individually.

Id. at 53.  That’s what a zero-dollar settlement like this one means.  Class members are giving up something and not getting anything.

  1. If cy pres is to be permitted at all, there should be strict restrictions against the payment of money to recipients with any significant current or prior relationship with the parties, attorneys, or judge.

In particular, this argument rejects “distribution of cy pres funds to class counsel’s alma mater instead of the class.”  Petitioner’s br. at 54.  This is just another questionable practice enabled by the creation of a “remedy” that is outside of both the law and the rules, and thus essentially ungoverned.

The better rule is to require settling parties to have the burden to demonstrate that neither the court nor any “party has any significant prior affiliation with the intended recipient that would raise substantial questions about whether the selection of the recipient was made on the merits.”

Id. at 55-56 (quoting – ironically – Principles of Aggregate Litigation §3.07, comment b).  Once again, bright line, prophylactic rules are best.  The potential for conflict of interest is simply too great to allow any cy pres award to an entity with ties to the litigants or to the court.

  1. At a minimum, courts should substantially discount cy pres distributions relative to direct payments to class members for purposes of calculating attorneys’ fees based on a percentage of the recovery.

In one paragraph, petitioner’s final argument is that the “indirect and attenuated” – if any – value of a cy pres settlement to any class member requires that such payments “should at least be heavily discounted in the fee calculation to better align incentives.”  Petitioner’s br. at 56-57.

If even a quarter of these arguments succeed, then cy pres distributions of class action settlements will – quite rightly in our view – be cast into the proverbial dustbin of history.  Perhaps Congress, or a state legislature for a state class action, could create such a remedy, but they haven’t.  Our bottom line is that no authority currently exists to allow courts, with or without the connivance of counsel, to take money belonging to certain persons (here, absent class members) and give that money to other persons (here, lawyer-selected charities) without the express approval of the original owners.

As one might expect, the Frank case also produced a bunch of interesting amicus briefs.  Since we spent much longer than we had expected on Ted’s brief, our rundown of the objector-side amici will be significantly briefer – but we’re providing links so anyone interested can read them in their entirety.

Of greatest interest, of course, is the position taken by the government itself – as to which we find a lot to like:

United States of America

The cy pres question need not be reached because Spokeo casts substantial doubt on whether the class representatives suffered sufficiently significant injury to confer Article III standing.  Brief at 11-15.

Cy pres as used in the trust area is irreconcilable with its use in class-action settlements.  Id. at 16-17.

Cy pres raises serious concerns where class members receive no compensation.  Id. at 18.

Cy pres raises serious concerns about collusion against the interests of absent class members.  Id. at 19-20.

Cy pres raises serious concerns about conflicts of interest by counsel and even courts.  Id. at 20.

Cy pres raises serious concerns about the creation of new, extra-statutory remedies.  Id. at 20-21.

Cy pres is improper unless it redresses the specific injuries of the plaintiff class.  Id. at 22-26.

Cy pres is improper when there is any non-arbitrary way of distribution to class members.  Id. at 26-28.

Cy pres distributions should be discounted, ideally entirely, in calculating attorneys’ fees.  Id. at 28-32.

In a nutshell, here are the highlights of other important amicus curiae briefs in Frank v. Gaos:

State Attorneys General – eighteen of them

Cy pres in consumer class actions diverts money away from injured consumers, aggravating the original problems, and should not be recognized.  Brief at 4-8.

Cy pres settlements circumvent statutory and judicial class action standards in violation of the Rules Enabling Act.  Id. at 8-11.

Once again, the Ninth Circuit is out of line.  Id. at 11-13.

Cy pres-only settlements should be per se invalid.  Id. at 13-16.

Cy pres awards should be disregarded in the calculation of attorneys’ fees.  Id. at 16-20.

Chamber of Commerce of the USA

If class actions were better policed at the front end, by denying class certification to no-injury class actions in the first place, the problems with cy pres settlements would never have arisen.  Brief at 5-11.

Cy pres settlements would not be needed if courts properly enforced Rule 23’s commonality and predominance requirements.  Id. at 11-13.

Injury should not be presumed for purposes of class certification.  Id. at 14-15.

Cy pres settlements are symptomatic of meritless, but expensive, class action litigation.  Id. at 16-18.

Conflicts between class counsel and absent class members are inherent in cy pres settlements.  Id. at 18-22.

If allowed at all, cy pres settlements should be strictly regulated.  Id. at 22-26.

Lawyers for Civil Justice

Cy pres awards are inherently inconsistent with Rule 23’s requirement that settlements be “fair, reasonable, and adequate.”  Brief at 9-10.

Cy pres, as it previously existed in non-adversarial trust law, has nothing to do with adversary class actions.  Id. at 11-14.

Cy pres is an improper exercise of judicial power under Article III of the constitution.  Id. at 14-18;

Cy pres violates the Rules Enabling Act by permitting fines against defendants not recognized by substantive law.  Id. at 18-20.

If otherwise permitted, cy would violate the Due Process rights of absent class members.  Id. at 20-21.

Compelling diverse class members to finance speech by either plaintiff-side or defendant-side advocacy groups violates the First Amendment.  Id. at 21-22.

The existence of a cy pres award indicates that the action itself cannot support class certification.  Id. at 23-24.

Cato Institute & Americans for Prosperity

Cy pres violates the Due Process and First Amendment rights of absent class members whose property is being taken and given to charities for the purpose of plaintiff-side advocacy.  Brief at 4-7.

Constitutional rights could be better protected by requiring opt-in class actions.  Id. at 8-10.

Cy pres inevitably leads to self-dealing and violation of professional ethics by class counsel.  Id. at 12-15.

Class counsel use cy pres to increase personal gain at the expense of absent class members.  Id. at 16-18.

Defendants utilize cy pres to lower settlement costs.  Id. at 18-19.

Cy pres erodes judicial neutrality through conflicts of interest in selecting recipients.  Id. at 19-20.

Zero dollar class actions cannot be “superior” to anything.  Id. at 21-22.

There are always better alternatives to cy pres awards.  Id. at 22-24.

Cy pres is a disguise for parties and courts to lobby for special benefits.  Id. at 24-25.

Once again, the Ninth Circuit is out of line.  Id. at 25-29.

Compelling diverse class members to finance speech by either plaintiff-side or defendant-side advocacy groups violates the First Amendment.  Id. at 29-34.

Manhattan Institute for Policy Research

Unlike cy pres in the trust area, which is legislatively recognized, cy pres in the class action context is not based on any recognized grant of power.  Brief at 7-13.

Cy pres violates the Rules Enabling Act by modifying substantive legal remedies.  Id. at 14-15.

Payments to charities are not a remedy recognized by substantive law.  Id. at 16-21.

Cy pres is only allowable where recognized by substantive law.  Id. at 21-23.

Center for Constitutional Jurisprudence & Atlantic Legal Foundation

A class action that cannot deliver any relief to class members does not present an Article III “case or controversy.”  Brief at 4-6.

Compelling diverse class members to finance speech by either plaintiff-side or defendant-side advocacy groups violates the First Amendment.  Id. at 6-8.

Center for Individual Rights

Compelling diverse class members to finance speech by either plaintiff-side or defendant-side advocacy groups violates the First Amendment.  Brief at 3-6.

Opt-out class actions violate the First Amendment.  Id. at 6-10.

New Jersey Civil Justice Institute

Cy pres converts Rule 23 class actions into a substantive remedial scheme.  Brief at 2-8.

An all-cy pres settlement cannot be “superior” under Rule 23 standards.  Id. at 9-16.

There are a couple of other briefs filed by persons with more narrow interests related to copyrights or internet privacy that we don’t think would be of sufficient interest to our members to bother with.

Finally, in accordance with the parties’ agreed-upon schedule, that appears to have been adopted by the Court, the pro-cy pres forces won’t start filing their briefs until the end of August.  With that schedule, it is quite possible that oral argument will occur before the end of the year.

Every now and then, the Reed Smith powers that be make seats in the firm’s skybox at the Phillies’ (first place – who woulda thunk?) stadium available to folks like us.  As a result we attended back-to-back concerts by the Eagles and Billy Joel last weekend.  Yes, we know that dates us – that was obvious from crowd demographics – but we don’t mind.  Joel (who according to Wikipedia, caught his first big break in Philly back in 1972) played until nearly midnight after the show’s opening was delayed by a cloudburst.  He made sure to perform “Allentown” with its Pennsylvania themes, but Joel being Joel, he also played “New York State of Mind.”

Our immediate Philadelphian chip-on-our-shoulder reaction was, “Don’t bring that New York %@#&*! down here.  If you have to sing about New York City, at least play “Miami 2017” (he didn’t).”  But then we got back to work, and we ended up thinking, actually there is at least one good recent reason for us to look to New York.

TwIqbal.

Over the last few weeks, New York courts have produced two of the best TwIqbal decisions that we’ve ever seen: Quintana v. B. Braun Medical, Inc., 2018 WL 3559091 (S.D.N.Y. July 24, 2018), and Oden v. Boston Scientific Corp., ___ F. Supp.3d ___, 2018 WL 3102534 (E.D.N.Y. June 4, 2018).  If more courts applied TwIqbal as faithfully as this duo, you know what?  Lawyers on the other side might actually have to comply with Rule 11 and actually investigate their cases before filing them.

Both cases involve Class II medical devices (IVC filters), so their TwIqbal application is not related to federal preemption and so-called “parallel” violation claims.  They’re just straight-out TwIqbal fundamentalism.  So, for those of you who file TwIqbal motions in order to force plaintiffs to plead what the heck their cases are about (most of us D-siders these days), and who use our TwIqbal Cheat Sheet to find good cases in your jurisdiction to cite, here’s a rundown of the relevant rulings.

Warning Defect

Given the nature of a warning-based product defect claim, “a claim premised upon a failure to warn theory should be dismissed in the event a plaintiff fails to plead facts establishing how or why the warning provided was inadequate.”  Oden, 2018 WL 3102534, at *6.  “[C]onclusory” warning allegations that failed TwIqbal are:

  • “Defendant failed to provide sufficient warnings and instructions”
  • “Defendant knew or should have known, and adequately warned that its product created a risk of serious and dangerous side effects, including but not limited to. . . .”
  • “The warnings given did not accurately reflect the risk, incidence, symptoms, scope or severity of such injuries to the consumer”
  • Defendant “only provides limited information [concerning] possible complications”
  • “Defendant’s warnings page on their website . . . fails to address the full extent of complications [and] magnitude of risks involved”

Id. None of this boilerplate, individually or collectively, survived TwIqbal.  “[T]he Complaint fails to provide facts identifying how or why the included warnings were inadequate.”  Id. at *7.  Given the warnings referenced in the complaint (labeling, product brochure, instructions for use, website), the complaint came nowhere near meeting TwIqbal requirements:

[T]he Complaint fails to provide facts identifying how or why the included warnings were inadequate.  Although Plaintiff claims that Defendant failed to warn or otherwise provided inadequate warnings of all of the aforementioned risks, the Complaint is silent as to how the warnings that were indisputably provided . . . were inadequate.  Moreover, Plaintiff has failed to provide the necessary factual nexus showing how the warnings that were provided were insufficient since merely asserting that warnings were not “adequate” or “sufficient” are nothing more than legal conclusions.  Without facts setting forth what the warnings stated and how and/or why the warnings were inadequate, Plaintiff’s failure to warn claim is insufficiently pleaded.

Id. at *7 (citations and quotation marks omitted).

Another pleading deficiency was the complaint’s failure to distinguish between “actual injuries Plaintiff experienced versus those complications which potentially could result from implantation of the [device].”  Id. (emphasis original).  “Nor does the Complaint contain any nonconclusory allegations that Plaintiff’s treating physician was not adequately informed or apprised of the potential risks.”  Id.  In a learned intermediary case, “to the extent Plaintiff’s failure to warn claim is premised upon Defendant’s alleged failure to warn ‘consumers’ . . . such a claim is not viable in the first instance.”  Id.  Thus a plaintiff must plead “facts to suggest that [the] physician did not possess independent knowledge about the risks associated with” the device.  Id.

Likewise, in Quintana, “Plaintiff’s allegations of inadequate warnings” were “for the most part, conclusory.”  2018 WL 3559091, at *6.  Plaintiff “fails to identify how those warnings were inadequate.”  Id.  Further, plaintiff failed to plead warning causation under the learned intermediary rule:

To this point, Plaintiff alleges, “as a direct and proximate cause of the wrongful acts and omissions of Defendants, Plaintiff suffered economic damages, severe injuries, and emotional distress.”  This conclusion, however, is not sufficient to plausibly show that the failure to warn Plaintiff’s physician caused Plaintiff’s injuries because we know nothing about what caused her [injury] – i.e., what about the device failed or what was Plaintiff’s diagnosis – nor anything about whether Plaintiff would have heeded an appropriate warning.

Id.

Design Defect

Oden held that a design defect claim is properly TwIqballed where it “fails to identify a particular problem in the design of [the device] and . . . merely plead[s] that the [device]  is ‘defective.’”  2018 WL 3102534, at *4.  A mere “list of allegedly unreasonable risks” “does not identify a specific component or particularized issue with the design itself.”  Id.  Similarly, describing a product as “unreasonably dangerous” when it “left the hands of the Defendant” does not adequately allege a defect.  Such descriptions “lack[] any facts indicating the particular component that was defective or otherwise identifying a specific problem.”  Id.  “Without such facts, Plaintiff’s design defect claim fails.”  Id.  Moreover, a design defect claim must allege an alternative design:

Plaintiff’s design defect claim also fails on the independent ground that the Complaint does not plead the existence of a feasible alternative design. . . .  [A] plaintiff must plead facts alleging the existence of a feasible alternative design.  The only paragraph in the Complaint specifically referring to this element merely states that “safer, reasonable alternative designs existed and could have been utilized,” but fails to identify what feasible alternative designs are available.

Id. at (citations and quotation marks omitted).  Pleading the availability of a “different” product (“retrievable,” as opposed to “permanent[]”) doesn’t hack it, “since the design and purpose of these two products is different.”  Id.

In pleading design defect, Quintana required plaintiffs to allege “a specific defect” as well as “facts about the “circumstances of the purported failure of the [device] that would give rise to the inference of proximate cause.”  2018 WL 3559091, at *4.  “A boilerplate reference to a design defect” that the product was “unable to withstand . . . normal” conditions failed TwIqbal.  Id.  As to product “risks,” a complaint must “state [] facts to indicate how those risks resulted from a specific design defect” and “how that defect was a substantial factor in causing [plaintiff’s] injuries.”  Id.  “[T]he assumption that [a] device must have failed because of reports of failures or complications by other consumers is plainly inadequate” to plead a design defect.  Id.  As in Oden, alleging a product to be “unreasonably dangerous” doesn’t adequately allege a defect.  Id.  A plaintiff must plead “how [a] problem rendered the product defective, whether it affected his [device], [and] how it caused [the] alleged injuries.”  Id. (citation and quotation marks omitted).  Further, “res ipsa loquitur is an evidentiary principle and does not apply to pleading requirements.”  Id. at *5.  Even if res ipsa were appropriate, it is insufficient when “Plaintiff fails to provide sufficient factual exposition to account for the possibility that other factors caused [the] injury.”  Id.  Finally, “[i]t also appears that Plaintiff’s design defect claim fails for failure to allege a feasible design alternative.”  Id. at 5 n.5.

Manufacturing Defect

The plaintiff’s “conclusory” allegations in Oden failed to plead a manufacturing defect “since they fail to allege a specific manufacturing defect affecting the [device] implanted in Plaintiff as compared to other [devices] that were produced by Defendant.”  2018 WL 3102534, at *5 (emphasis original).  “[A] claim devoid of allegations that a particular unit differed when compared to others in the same product line will be dismissed.”  Id.  “[A]lleg[ing] that some ‘condition or conditions’ existed that ultimately caused Plaintiff’s injuries” is a “vague assertion” that “fails to place Defendant on notice as to what the particular error in the manufacturing process was.”  Id.

Quintana did not involve a manufacturing defect claim.

Express Warranty

Oden reiterated that, to pursue a claim for breach of express warranty, “plaintiff must allege that there was an affirmation of fact or promise by the seller, the natural tendency of which was to induce the buyer to purchase and that the warranty was relied upon to [Plaintiff’s] detriment.”  2018 WL 3102534, at *8 (citation and quotation marks omitted).  An allegation that, somewhere in the defendant’s “literature, advertisements, promotions and . . . representations by their marketing team and sales agents,” a promise was made that the device was “safe, effective and fit for implantation” in various ways didn’t cut the mustard.  Id.  Even assuming these were “material statements amounting to a warranty,” no reliance was pleaded:

[T]he Complaint merely alleges Plaintiff’s purported “reliance” without providing any underlying factual details concerning when, where and how such reliance arose. Even assuming that Plaintiff was provided with a brochure . . ., the Complaint is devoid of any facts that would permit the inference that Plaintiff actually read these statements and directly relied upon them when making the decision to utilize Defendant’s product.  In addition, there are no facts illustrating that Plaintiff’s physicians ever reviewed the statements contained on Defendant’s website or those set forth in the product brochure prior to making the decision to recommend use of the [device].  Without such allegations, any purported claim that such reliance existed is implausible.

Id. at *9 (citations and quotation marks omitted).

In Quintana express warranty claims failed equally miserably.  “Plaintiff has failed to adequately plead reliance because her amended complaint lacks details regarding whether and how Plaintiff or her physicians reviewed and relied upon these warranties.”  2018 WL 3559091, at *7 (citations omitted).

Implied Warranty

Quintana did not involve implied warranty claims, but Oden did – two claims, for both merchantability and fitness for a particular purpose.  2018 WL 3102534, at *9-10.  Merchantability claims were TwIqballed, for lack of a proper defect claim, as already detailed.  Id. at *9.  Fitness claims failed because they were “altogether conclusory.”  Id. at *10.  “Where a plaintiff fails to plead that a defendant knew of the particular purpose for which that plaintiff was buying a product, a complaint will be dismissed.”  Id. at *9 (citation and quotation marks omitted).  This complaint didn’t so plead.  Id. at *10.  “[A] product’s intended or ordinary purpose is not necessarily equivalent with a particular purpose for which Plaintiff seeks to purchase a product.”  Id.  “Moreover, the Complaint does not contain any factual allegations leading to the inference that Defendant was aware that Plaintiff and/or his physicians were directly relying upon Defendant’s skill and judgment when the determination was made to purchase the” device.  Id.

Other

Both the Oden and Quintana complaints also contained the usual litany of fraud, fraudulent concealment, negligent misrepresentation, and consumer fraud claims.  These were all dismissed as well.  Oden, 2018 WL 3102534, at *10-15; Quintana, 2018 WL 3559091, at *7-10.  The fate of these claims was mostly decided under the particularity standards of Fed. R. Civ. P. 9(b) rather than TwIqbal.  Oden was of the view that the consumer fraud claims were subject only to TwIqbal standards, 2018 WL 3102534, at *14, and dismissed them on that basis:

[T]his cause of action fails because Plaintiff has not sufficiently pleaded causation.  Although Plaintiff sets forth certain statements contained on Defendant’s website and in its product brochure, these allegations neither explicitly state nor permit the plausible inference that Plaintiff actually saw these statements prior to making the determination (in conjunction with his physicians) to purchase the [device]. . . .  [T]he relevant factual background to support the above [allegations] is simply lacking.  As a result, Plaintiff has failed to sufficiently plead the third element of this claim.

Id. (citations omitted).

Quintana dismissed consumer fraud claims on the same basis, 2018 WL 3559091, at *10, although it is unclear whether the dismissal was under Rule 8 or Rule 9(b).  Unlike Oden, Quintana also applied TwIqbal to the plaintiff’s negligent misrepresentation claim, out of an abundance of caution, id. at *9 and held the claim inadequately pleaded under the learned intermediary rule.

[E]ven under the more lenient standards of Rule 8(a), Plaintiff’s negligent misrepresentation fails because she has not plausibly alleged reliance. . . .  [Plaintiff’s] allegation indicates only that Plaintiff relied on her physician’s advice and leaves open the question whether the physician relied on Defendants’ representations when giving Plaintiff that advice.  Because Plaintiff fails to plausibly allege what misrepresentation her physician relied on, her negligent misrepresentation claim is dismissed.

Id.

Finally, remember that we’re very picky on our TwIqbal Cheat Sheet.  We only include cases where a motion to dismiss was granted in its entirety.  In none of our 200+ drug/device TwIqbal cases did a single claim survive dismissal (sometimes on grounds other than TwIqbal).  New York has always been a productive source for TwIqbal Cheat Sheet cases:

Black v. Covidien, PLC, 2018 WL 573569 (W.D.N.Y. Jan. 26, 2018); Rincon v. Covidien, 2017 WL 2242969 (S.D.N.Y. May 22, 2017); Teixeria v. St. Jude Medical S.C., Inc., 193 F. Supp.3d 218 (W.D.N.Y. 2016); Morrison v. Hoffmann-La Roche, Inc., 2016 WL 5678546 (E.D.N.Y. Sept. 29, 2016); Adams v. Stryker Orthopaedics, 2016 WL 2993213 (S.D.N.Y. May 23, 2016); Ortiz v. Allergan, Inc., 2015 WL 5178402 (S.D.N.Y. Sept. 4, 2015); Rodman v. Stryker Sales Corp., 2014 WL 5002095 (S.D.N.Y. Oct. 7, 2014), aff’d, 604 F. Appx. 81 (2d Cir. 2015); Cordova v. Smith & Nephew, Inc., 2014 WL 3749421 (E.D.N.Y. July 30, 2014); Burkett v. Smith & Nephew GMBH, 2014 WL 1315315 (E.D.N.Y. March 31, 2014); Simon v. Smith & Nephew, Inc., 990 F. Supp.2d 395 (S.D.N.Y. 2013); Bertini v. Smith & Nephew, Inc., 2013 WL 6332684 (E.D.N.Y. July 15, 2013); Goldin v. Smith & Nephew, Inc., 2013 WL 1759575 (S.D.N.Y. April 24, 2013); In re Pamidronate Products Liability Litigation, 842 F. Supp.2d 479 (E.D.N.Y. 2012); Reed v. Pfizer Inc., 839 F. Supp.2d 571 (E.D.N.Y. 2012); Bowdrie v. Sun Pharmaceutical Industries Ltd., 2012 WL 5465994, (E.D.N.Y. Nov. 9, 2012); Desabio v. Howmedica Osteonics Corp., 817 F. Supp.2d 197 (W.D.N.Y. 2011); Gelber v. Stryker Corp., 752 F. Supp.2d 328 (S.D.N.Y. Sept. 14, 2010); In re Fosamax Products Liability Litigation, 2010 WL 1654156 (S.D.N.Y. April 9, 2010); Ilarraza v. Medtronic, Inc., 677 F. Supp.2d 582 (E.D.N.Y. 2009); Horowitz v. Stryker Corp., 613 F. Supp.2d 271 (E.D.N.Y. 2009); Lewis v. Abbott Laboratories, 2009 WL 2231701 (S.D.N.Y. July 24, 2009).

But you will find a couple of citations in Quintana and Oden to TwIqbal cases that we don’t include because they only dismissed complaints in part.  See Parillo v. Stryker Corp., 2015 WL 12748006 (N.D.N.Y. Sept. 29, 2015); DiBartolo v. Abbott Laboratories, 914 F. Supp.2d 601 (S.D.N.Y. 2012).  That’s OK – it’s a matter of legal judgment what to cite for any particular proposition.  Our philosophy is that we want to be picky, so we don’t give anyone a bum steer with a case citation that may be harmful on some other TwIqbal point.  As Billy Joel would say, “It’s no big sin to stick your two cents in if you know when to leave it alone.”