This DDL blogger happens to have a relatively new teenager in the house. And said teen has been working on an assignment related to the novel by Lois Lowry, “The Giver.” If you are unfamiliar with the book or the more recent movie adaptation (and if you only know the movie, we recommend the book as the former doesn’t dig deep enough into the source material’s thought-provoking ideas), it is about a seemingly utopian society without war, poverty, pain, or suffering. This state of perfection is achieved through sameness. Everyone dresses the same, speaks the same, acts the same. The goal is to eliminate all conflict and for no one to feel uncomfortable. And to achieve this, free will and freedom of choice are non-existent.

The book’s themes have made for some very interesting dinner table debates about the benefits and drawbacks of sameness. While we’ve managed to identify the obvious benefits, we also always find the benefit comes at a price that we are typically not willing to pay. Sacrificing the ability to feel love to also not have to endure feeling pain. Sacrificing human life so that there is no hunger. So, in this DDL household, sameness has come under considerable attack and it is no surprise that individuality is being championed by the teen (and parent too, with some limitations).

And as we transition from home life to work life, we couldn’t help but acknowledge the parallel as we again find ourselves the advocates of individuality over sameness. This time it’s about a flawed class rather than a dystopian society.

In Andre v. Alere, 2018 U.S. Dist. LEXIS 69045, *3 (S.D. Cal. Apr. 24, 2018), putative class representatives allege that defendants’ marketing of its INRatio products was deceptive and misleading and that defendants are therefore liable under various state’s consumer protection laws. The INRatio products are handheld devices used to monitor blood clotting time in people taking warfarin. Class certification was originally denied back in December as to both a nationwide class and as to alleged state-specific sub-classes. Id. at *4-5. Plaintiffs sought reconsideration as to the six sub-class states (Colorado, Florida, Georgia, Maryland, New York, and Pennsylvania). They allege that based on new facts they can satisfy Federal Rule of Civil Procedure 23(b)(3)’s predominance requirement as to the learned intermediary doctrine, statute of limitations, and damages. The court disagreed.

For a class to be certified, Rule 23(b)(3) requires that “the question of law or fact common to class members predominate over any questions affecting only individual members.” And the court’s analysis is a “rigorous” one that can extend beyond the pleadings. Id. at *6.

Plaintiffs, for the first time in their reply brief, argued that the learned intermediary doctrine did not apply to their claims for several reasons. First, they alleged it does not apply because they are alleging a design defect claim not a failure to warn claim. But, that argument didn’t align with the allegations of their complaint which were about omissions and representations – i.e. failure to warn. Id. at *14. Nor did plaintiffs’ cite any authority for learned intermediary not applying to design defect claims. Id. Next plaintiff argued that the learned intermediary doctrine doesn’t apply where only economic injuries are sought. But again, they offered no legal support for their contention. Id. Finally, plaintiffs argued that because the INRatio product is user-operated, the doctrine doesn’t apply. On this point, it appears plaintiffs and defendants submitted competing examples of how prescribed medical devices that involve some patient operation are treated and concluded plaintiff’s argument was not persuasive. Id. at *15. Regardless of whether the patient has to be the one to use the device daily, it still had to be prescribed by his/her physician warranting application of the learned intermediary doctrine.

So, since the learned intermediary doctrine is applicable, Plaintiffs had to argue that it is subject to “common proof.” They did this by alleging that defendants “failed to warn any physicians.” Id. at *7-8 (emphasis added). But, as defendants argued, the inadequacy of the warning is only part of the equation. Plaintiffs must also show that “the inadequate or lack of warnings were the proximate cause of Plaintiffs’ injuries.” Id. at *8. The court cites at least one case from each of the six states at issue to support the proximate cause arm of the learned intermediary rule. Id. at *10-11. What all of those cases have in common is the conclusion that “proximate cause determination will ultimately lead to individual inquiries into each doctor’s experience with the product.” Id. at *12. Inquiries such as the extent of the physician’s knowledge of the risks and side effects and the source of that knowledge; and whether the physician stands by his/her prescribing decision; and the physician’s individualized medical decision based both on his/her knowledge of the product and of the patient. Id. at *12-13. While warning adequacy might be subject to common proof, individuality predominates on the issue of specific, proximate causation. Also, plaintiffs couldn’t point to a single case where class certification was granted involving the learned intermediary doctrine.

Class certification was also denied due to the lack of predominance as to damages and the statute of limitations. Again, individuality can’t be ignored.

On damages, plaintiffs put forth a full-refund model under California law and argued that it satisfied predominance and that a state-by-state analysis was not necessary. Id. at *16-17. The court, however, found that the cases plaintiffs relied on were not that black and white. See id. at *17-19 (analyzing plaintiff’s cases).      It was not enough to summarily conclude that predominance was satisfied as to all because it was satisfied as to some. The required “rigorous analysis”

is not satisfied by merely arguing that courts in some of the six states allow for a full refund model. Plaintiffs have failed to specifically demonstrate that each of the six sub-class states’ consumer protection statute and claims for implied breach of warranty in four sub-class states are connected to their theory of damages or that these state law causes of action damages provide for a full refund recovery.

Id. at *21. Plaintiffs had to show sameness among the six states, which it failed to do.

As to statute of limitations, plaintiffs argued that because each of the six states recognizes equitable tolling and/or the discovery rule, “then necessarily common proof will prevail over individualized questions” because no plaintiff knew until the product was recalled that the product was defective. Id. at *22-23. But plaintiffs ignore that both equitable tolling and the discovery rule require consideration of whether the plaintiff acted with due diligence – an individualized inquiry. Id. at *23. The court gives an example from the complaint of one of the putative class representative’s experiences with the device that should have alerted him to an issue before recall and points out that plaintiffs have not addressed how equitable tolling or the discovery rule would apply in that situation. Id. at *24. Since it cannot be determined if the statute would be tolled for all plaintiffs from the date of recall, individual issues predominate over common ones.

In “The Giver” sameness is a metaphor for the lack of truth and diversity. The destroyer of creativity, free will, joy, happiness, and love. The things that make life worth living. In DDL world individuality may not be the meaning of life, but it’s enough to ward off class actions which certainly makes us happy.

Sure, it was enjoyable to read In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Product Liability Litigation, ___ F.3d ___, 2018 WL 1954759 (5th Cir. April 25, 2018) (“Pinnacle Hip”), to see plaintiffs’ counsel hoisted on their own petard of improper and prejudicial evidence and arguments.  But there’s more to Pinnacle Hip than “Lanier-on-a-spit,” as it has been described in these parts.  Indeed, blogging plaintiffs’ attorney Max Kennerly, dropped a comment to our first Pinnacle Hip post (which we published – we scrub only spam, not opposing views) asserting that “the rest of the opinion was a huge win for plaintiffs.”

We largely disagree with Max’s comment, and this post explains why.

Initially, we note that the defendant in Pinnacle Hip was swimming decidedly upstream in all of its legal arguments, since it was opposing a jury verdict entered against it and seeking entry of judgment as a matter of law in its favor.  2018 WL 1954759, at *2.  That means all the trial evidence is construed in the plaintiffs’ favor.  Id. at *3 (“JMOL is warranted only if a reasonable jury would not have a legally sufficient evidentiary basis to find for the nonmovant.”) (citations and quotation marks omitted).

Design Claims

The first claim addressed in Pinnacle Hip was design defect.  See 2018 WL 1954759, at *3-9.  The defendant raised several arguments, all unsuccessfully.  First, the defendant argued that plaintiff had failed to satisfy the Texas alternative design requirement because that alternative that the plaintiffs offered – a “metal on plastic” (“MoP”) hip implant – was really a “different product” from the defendants’ metal-on-metal design (“MoM”), and thus cannot serve as a design alternative.  This is an argument we have featured several times on the blog.  In Pinnacle Hip, the conclusion was that “based on the record, that MoP is a viable alternative design to MoM.”  Id. at *4.

While we would have liked to win this, on the facts, this distinction between alternative product and design is more difficult for the defense than in the cases we’ve discussed in our prior posts, which usually involve not using the product at all, or using some other product that is much less suited for the use in question.  Our classic example of alternative cause abuse is Theriot v. Danek Medical, Inc., 168 F.3d 253 (5th Cir. 1999), a Bone Screw case in which the supposed “alternative” was a different type of surgery not using the product at all.  That’s distinct from redesigning one part of a device system to use a different material, as indeed, Pinnacle Hip pointed out.  2018 WL 1954759, at *9.  Pinnacle Hip reaffirmed that similar-use products that “fail[] to perform the discrete kinds of functions for which the alleged defective was designed” or with a “wide disparity in price” cannot be considered alternative designs.  Id. at *4, *7.  However , the risk/utility defect test “contemplates that a proposed alternative design might reduce a product’s utility . . . without rendering the alternative an entirely different product.”  Id. at *5.  That means some variation has to exist without “moot[ing] the entire defect test.”  Id.

Construing the record to favor plaintiffs, Pinnacle Hip resulted in another point on the uncertain, “practically impossible to settle in the abstract,” id., at *4, line between different design and different product.  While we’d like to have won, Pinnacle Hip does not move the line itself in any lasting fashion prejudicial to the defense.  The ultimate holding was that a “cross-linked” MoP is not sufficiently different from the defendant’s MoP design to be considered a different product.  2018 WL 1954759, at *6 & n.13.  The underlying principle that the distinction between product and design seeks to protect is preventing automatic liability against whole classes of products – cigarettes, motorcycles, birth control pills, or pedicle screw fixation devices – for simply being what they are and having certain inherent risks.  That principle remains intact after Pinnacle Hip.

The defendants also lost a preemption argument – that design defect claims “’stand[] as an obstacle to the accomplishment and execution of the full purposes and objectives’ reflected in the MoM-related regulations of the FDA.”  2018 WL 1954759, at *7.  According to the defendants, because the plaintiffs were seeking “categorical” liability, that all MoMs should be “banned outright,” there should be preemption. Id. at *8.  But that’s not what the Fifth Circuit found was what happened:

[I]t is not the case that plaintiffs’ theory reached all possible MoMs.  All would agree that, despite the sweeping language with which plaintiffs presented their case, their claims were impliedly limited to presently available technologies and the adverse health effects they allegedly engender.

Id.  But the record showed that “[t]he FDA effectively withdrew all MoMs from the market . . . and left open a single door in the form of PMA.”  Id.  On this set of facts, it could not be said that banning something that the FDA had already essentially removed from the market, save for an alternative that has not yet produced an FDA-approved product, was an interference with “the FDA’s regulatory objectives.”  Id.

While losing a preemption argument is not something we would recommend, this particular type of preemption argument has never been successful that we are aware of, so it’s no great loss.  We’ve advocated at some length that the Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), decision be overturned.  But that argument is predicated on changes to 510(k) clearance created by Congress in 1990.  In Pinnacle Hip, “MoMs were sold before 1976 and have traditionally been treated as pre-amendment class III devices.”  2018 WL 1954759, at *8.  So Pinnacle Hip doesn’t affect even the distinctions that we draw from Lohr.  The preemption argument rejected in Pinnacle Hip would require the complete reversal of Lohr, even on Lohr’s facts, to succeed.

By far the better preemption argument, based on current law, with respect to 510(k) design defect claims, is that they amount to “major changes” that require prior FDA review, and probably an entirely new supplemental submission, before they could be implemented.  That should put design defect claims at odds with the “independence principle” in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), resulting in preemption of all design claims that could make a difference in a product liability action.  That argument, which does not depend on Lohr either way, was not addressed at all in Pinnacle Hip.

Finally, the defendants in Pinnacle Hip also lost on their Restatement (Second) of Torts §402A, comment k (1965), argument, which was that Texas law holds all prescription medical products, including medical devices, to be “unavoidably unsafe” within the meaning of comment k, so that those “unavoidable” risks can only be warned about and not treated as design defects.  Pinnacle Hip was unwilling to expand Texas’ application of comment k from prescription drugs to include prescription medical devices.  2018 WL 1954759, at *9.  That places Pinnacle Hip in a distinct minority position, since literally hundreds of cases, and the Third Restatement, apply limits on design defect claims equally to all types of prescription medical products.  Bexis’ book collects these cases.  Drug & Medical Device Product Liability Deskbook §2.02[2] at pp. 2.02-13 to -16 n.14 (for the proposition that “almost all courts have extended the unavoidably unsafe product exception to medical devices”).  However, as the Fifth Circuit correctly pointed out, not many of those opinions are under Texas law.

The further discussion of case-by-case versus across-the-board comment k application in Texas, 2018 WL 1954759, at *9, is more troubling, as the trend in Texas courts (in drug and vaccine prescription product cases) has favored the “blanket” approach.  Pinnacle Hip complained, in a footnote, that “Texas caselaw offers almost no guidance on how to go about that case-by-case inquiry.”  Id. at *9 n.22.  There is good reason for that lack of precedent – because Texas law has not employed tests that require such inquiry.  See Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1273 (5th Cir. 1974) (applying comment k without case-by-case analysis to a vaccine; holding that the only viable claim was inadequate warning); Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 930 F. Supp.2d 808, 817-18 (S.D. Tex. 2013) (applying comment k to prescription drug without case-by-case analysis); Woodhouse v. Sanofi-Aventis United States LLC, 2011 WL 3666595, at *3-4 (W.D. Tex. June 23, 2011) (holding, without further analysis, that “comment k applies to products such as [defendant’s prescription drug]); Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007) (“Prescription drugs are not susceptible to a design defect claim where, as here, the drug is ‘accompanied by proper directions and warning.’”) (quoting comment k); Carter v. Tap Pharmaceuticals, Inc., 2004 WL 2550593, at *2 (W.D. Tex. Nov. 2, 2004) (“Under Texas law, all FDA-approved prescription drugs are unavoidably unsafe as a matter of law”); Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 595 (W.D. Tex. 2002) (“under Texas law and comment k of the Restatement, Defendants can only be held strictly liable if the drug was not properly prepared or marketed or accompanied by proper warnings”).  Contra: Adams v. Boston Scientific Corp., 177 F. Supp.3d 959, 965 (S.D.W. Va. 2016) (refusing to apply comment k across-the-board in medical device case) (applying Texas law).  The comment k portion of Pinnacle Hip is where we think that Max is on the firmest ground.  The decision made Texas law worse.  This issue will ultimately be won in Texas appellate courts or perhaps before the Texas legislature, where it would be quite simple to extend the warning related presumption of §82.007 to all medical devices approved or cleared by the FDA.

Warning Claims

As to warning claims (which Texas law calls “marketing defects”), the defendants lost on adequacy as a matter of law.  Pinnacle Hip, 2018 WL 1954759, at *10.  Unfortunately, defendants usually lose on this ground, so it’s big news – and trumpeted on this blog – when a defendant wins a judicial holding that its warning is adequate as a matter of law.  No surprise there.  In Pinnacle Hip, that discussion ended:

Not until after the FDA issued its proposed rule in 2013 did defendants specifically warn about the metallosis, pseudotumors, and tissue necrosis − the sorts of conditions that plaintiffs maintained caused their revision surgery.

Id. at 11.  As defense counsel, we interpret the Fifth Circuit’s observation as an invitation to seek an adequacy as a matter of law ruling as to post-2013 claims (if there are any) in the litigation.

In the causation discussion pertaining to the warning claims, Pinnacle Hip of course followed the learned intermediary rule.  It discussed the role of “objective” evidence of causation:

At the threshold, the parties debate the relevance, under Texas law, of “objective evidence” − that is, evidence “that a different warning would have affected the decision of a reasonable doctor.” . . . Here, plaintiffs proffered objective evidence in [expert] testimony that, if the full risks of MoM were known to physicians, “they would run to [a different product].”

2018 WL 1954759, at *11 (citations omitted).  As we’ve discussed before, “objective” expert testimony about what “reasonable physicians” would have done is usually disallowed in learned intermediary cases.

On this point, however, Fifth Circuit law, has not been as favorable as other courts.  In Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 812 (5th Cir. 1992), the court actually allowed expert testimony on what a “reasonable” physician might have done – but that case was under Mississippi law.  See Ackermann v. Wyeth Pharmaceuticals, Inc., 526 F.3d 203, 212 (5th Cir. 2008) (suggesting that Thomas would not apply to Texas law).  We’ve been aware of the brief Texas Supreme Court passing reference to “objective” evidence in Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 171 (Tex. 2012) (plaintiffs “presented no objective evidence”), but felt no reason to let the other side know it was there.

Now it’s been discovered, however.  The Fifth Circuit allowed such evidence to be admissible, 2018 WL 1954759, at *12 (“objective evidence is at least relevant”), but did not find it decisive in situations where the plaintiff would otherwise have suffered dismissal.  Critically, Pinnacle Hip did not allow unsupported “expert” testimony about what an objectively “reasonable physician” would have done be enough to let plaintiffs survive when they didn’t have prescriber testimony – which would have been the equivalent of allowing a heeding presumption in Texas, something the Fifth Circuit rejected outright in Ackerman, 526 F.3d at 212-13.

Relevance, however, does not imply sufficiency.  In the [learned intermediary] context, causation entails two distinct factual predicates:  first, that the doctor would have read or encountered the adequate warning; and second that the adequate warning would have altered his treatment decision for, or risk-related disclosures to, the patient.  Centocor addressed only the latter, suggesting a jury might be allowed to presume a particular physician would respond “reasonably” to fuller disclosure.  But that presumption must yield to contrary subjective testimony by the treating physician, and Centocor fails to explain how objective evidence would apply to whether that doctor would have read or encountered the warning in the first instance.  When considered for the limited purpose intimated in Centocor, objective evidence would have little bearing on any of [these] plaintiffs’ claims.

Pinnacle Hip, 2018 WL 1954759, at *12 (footnotes omitted) (emphasis original).  Thus, where the plaintiffs had no testimony from their prescribing physicians, those claims continue to fail, and some “expert” claiming otherwise cannot change the result.  Id. (granting JMOL in no-prescriber testimony cases).  Likewise, any “objective” testimony “must yield to contrary subjective testimony by the treating physician.” Id.  So plaintiffs cannot create questions of fact with expert testimony where the prescriber has affirmatively testified that a different warning would not have changed what s/he did.

Only what the Fifth Circuit described as “mixed bag” prescriber testimony (the prescriber said different things in different parts of his testimony) cases got to the jury in Pinnacle Hip, id. at *13, and those have always been harder cases for the defense anyway.  At best, for plaintiffs, paying some expert to opine that a “reasonable” physician would have heeded a warning won’t save any plaintiff who lacked a plausible warning causation case in the first place.  At worst, Pinnacle Hip means more plaintiff-side noise at trial in cases already going to trial on warning causation.  All in all, the defense side is better off after Pinnacle Hip than where it had been in the Fifth Circuit with only the Thomas precedent.  We definitely don’t agree with Max here.

Personal Jurisdiction

In Pinnacle Hip, the manufacturer’s parent corporation was held potentially liable because of the amount of guidance and control permitted by an inference from the facts (based on a “clear error” standard).  2018 WL 1954759, at *15.  Those facts allowed the court to conclude that more than a “passive parent-subsidiary relationship” existed as to this product.  Id. at *16.  To us that’s “big whoop” for two reasons.  First, the “clear error” standard does not apply at the district court level where jurisdictional motions are initially decided.  Second, and more important going forward, the plaintiffs proceeded under a “stream of commerce” theory where the Fifth Circuit had previously “embraced [the] more expansive” (Brennan) side of the 4-4 split in Asahi Metal Industry Co. v. Superior Court, 480 U.S. 102 (1987).  Pinnacle Hip, 2018 WL 1954759, at *15.  As we’ve discussed, that broad “stream of commerce” jurisdictional theory is probably toast after Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017).  Pinnacle Hip did not even cite BMS in its discussion of personal jurisdiction, so we guess that this argument wasn’t raised.  In light of the BMS precedent, the Pinnacle Hip jurisdictional holding should be treated as something of a “one-off” applicable to this MDL, but not to future litigation where BMS will stand front and center.

Miscellaneous Claims

Pinnacle Hip includes the Fifth Circuit’s full-throated reaffirmance of our favorite Erie principle:

[T]hat debate [about what a Texas court might do] is beside the point.  When sitting in diversity, a federal court exceeds the bounds of its legitimacy in fashioning novel causes of action not yet recognized by the state courts.  Here, despite ample warning, the district court exceeded its circumscribed institutional role and expanded Texas law beyond its presently existing boundary.

2018 WL 1954759, at *17 (footnote, citations, and quotation marks omitted) (emphasis added).  The court therefore threw out the spurious invention of an “aiding and abetting” cause of action that had no reasonable predicate in Texas law.  Id.

The court did allow two arguably weird theories against the parent corporation – all product liability theories imposing liability against a non-manufacturing parent under a theory not also cognizable against the manufacturing subsidiary are likely to be weird − to survive.  One of those, so-called “nonmanufacturer seller” was tied to statutory exceptions to immunity for nonmanufacturers.  Id. at*18.  The court held, instead, that the parent was only held liable for old-fashioned design or warning liability, after the record (again, construed in favor of plaintiffs as verdict winners) established one of statutory exceptions from nonmanufacturer immunity.  Id. That’s a little peculiar to non-Texas lawyers, but since Texas has this statute, it must mean something.

The other oddball claim that survived is one of those “last refuge of a scoundrel” theories, negligent undertaking” (a/k/a “Good Samaritan”) liability.

Texas caselaw reveals no precise control threshold a parent must cross before undertaking a duty to its subsidiary’s customers.  Texas courts have made clear that mere possession of “the authority to compel” a subsidiary is not enough − the parent “must actually” exercise that authority in a manner relevant to the undertaking inquiry.

Pinnacle Hip, 2018 WL 1954759, at *19 (footnote omitted).  Based on the stringent standard for interpreting record evidence, the court let this one slide.  Id.  Not good, but not likely to arise very often.

But there’s more afoot than just these three theories. Two years ago, we awarded In re DePuy Orthopaedics, Inc., 2016 WL 6268090 (N.D. Tex. Jan. 5, 2016), our ranking as the number six worst decision of that year, chiefly because of the large number of unprecedented theories under Texas law that this opinion permitted:

(1) extending negligent misrepresentation beyond “business transactions” to product liability, unprecedented in Texas; (2) ignoring multiple US Supreme Court decisions that express and implied preemption operate independently (as discussed here) to dismiss implied preemption with nothing more than a cite to the Medtronic v. Lohr express preemption decision; (3) inventing some sort of state-law tort to second-guess the defendant following one FDA marketing approach (§510k clearance) over another (pre-market approval), unprecedented anywhere; (4) holding that the learned intermediary rule does not apply whenever a defendant “compensates” or “incentivizes” physicians to use its products, absent any Texas state or appellate authority; (5) imposing strict liability on an entity not in the product’s chain of sale, contrary to Texas statute (§82.001(2)); (6) creating a claim for “tortious interference” with the physician-patient relationship, again utterly unprecedented; (7) creating “vicarious” breach of fiduciary duty for engaging doctors to serve as expert witnesses in mass tort litigation also involving their patients, ditto; and (8) construing a consulting agreement with a physician as “commercial bribery” to avoid the Texas cap on punitive damages, jaw-droppingly unprecedented.

While only item (5) was at issue in Pinnacle Hip, the Fifth Circuit’s invocation of Erie conservatism bears ill for all of the other judicial flights of fancy that have been allowed during the course of the Pinnacle Hip litigation.

Constitutionality of Punitive Damages Cap

For completeness, plaintiffs also lost their constitutional challenge to the Texas statute capping punitive damages at twice compensatory damages.  “Plaintiffs’ cross-appeal is meritless, and we dispose of it by footnote.”  Pinnacle Hip, 2018 WL 1954759, at *1 n.4.  That footnote went further, and characterized those constitutional claims as “frivolous.”  Id. at *23 n.72.  No matter what the constitutional challenge, a punitive damages cap “need only survive rational-basis review,” which it did in Pinnacle Hip “by injecting predictability into exemplary damages awards and preempting potentially unconstitutional awards.”  Id. (citations omitted).

Conclusion

When all is said and done, we view Max’s characterization of Pinnacle Hip as a “huge win for plaintiffs” as mostly overblown hyperbole, perhaps worthy of inclusion in the closing arguments that the Fifth Circuit held warranted a new trial.  The Fifth Circuit did some damage to comment k, but all the rest of the legal holdings were trivial, fact-bound, not likely to be useful in future cases, or some combination of those.  The forceful reiteration of conservative principles of Erie predictions of state law leave us hopeful that the Pinnacle Hip MDL will see some Fifth Circuit-mandated clean up – or, if not, perhaps the appellate court’s not-so-veiled Parthian, parting shot may have to be fired in earnest:

[D]efendants, despite their serious critiques of the district judge’s actions in this case and related MDL proceedings, see In re DePuy Orthopaedics, Inc., 870 F.3d 345, 351 (5th Cir. 2017) (finding “grave error”), have not asked us to require these cases to be reassigned to a different judge under “this court’s supervisory power to reassign,” United States v. Stanford, 883 F.3d 500, 516 (5th Cir. 2018).  We express no view on the issue but note that reassignment is both “extraordinary” and “rarely invoked.”  Id. (citation and internal quotation marks omitted).

Pinnacle Hip, 2018 WL 1954759, at *27, n.83.  Obviously, the Fifth Circuit in Pinnacle Hip was uncomfortable with the prospect of overruling the JPMDL’s assignment of this MDL, but this final footnote stands as a clear warning that, if further provoked (such as by continuing consolidated trials, or resort to other prejudicial evidence that the court noted but did not rule on), it will consider doing so.

With the nicer weather quickly approaching, we have been told that Chicago, IL is the place to be from June 13-15. Is something special happening in Millennium Park? Are the Cubs playing the Cardinals at Wrigley? Do the ChiSox still exist?

We found something even better.  American Conference Institute, in collaboration with HP, are presenting the first Legal, Regulatory, and Business conference on 3D Printing. This program is a “can’t miss” industry event that prepares those in the 3D printing community with the knowledge they need to tackle the rapidly rising regulatory, IP, and product liability challenges in this space.

In addition to being present to say some friendly hellos, Bexis will be taking part in one of the more anticipated sessions “3D Printing Potential Product Liability Issues” focusing on theories of liabilities companies in the industry will face, potential defenses that can be utilized, and ways in which companies can minimize their product liability risks.

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

  • First, the discounted rates for the program end Friday, May 11th making now the best time to register for the event, if you have yet to do so.
  • Second, as a thank you for Bexis’s participation in the program, ACI is offering a special registration discount for the conference for the blog’s readers. Make sure to use the code D10-767-BCK10 when you register. You will save 10% off published rates.

We look forward to seeing you in Chicago this June for an outstanding event!

Today’s post is another guest post from friend of the Blog Kevin Hara, of Reed Smith, who channels our resident movie critic in this wide-ranging discussion of pleading and procedural weirdness.  As always with our guest posts, the author deserves 100% of the credit, and any blame, for what follows.

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If ever one wanted to feature a case where the plaintiffs and their attorneys fumbled and stumbled around like Keystone cops, it would be Paulsen v. Abbott Laboratories, 2018 U.S. Dist. LEXIS 50256 (N.D. Ill. March 27, 2018), involving the prescription drug Lupron, used to treat endometriosis.  The case really reminded me of the madcap, masterful ensemble movie, “It’s A Mad, Mad, Mad, Mad World” (hereinafter, “Mad World”) (yes, it’s a bit dated in some ways, but it still merits watching if you haven’t) with a veritable Who’s Who of 1950s-1960s Hollywood comedy royalty, including Edie Adams, Sid Caesar, Milton Berle, Ethel Merman, Jonathan Winters, Terry Thomas, Mickey Rooney, Phil Silvers, and Buddy Hackett.  Not to mention two time Oscar Winner Spencer Tracy and Jimmy Durante, who literally kicks the bucket as his character passes away and starts the mayhem.  Even if one does not consider the film a classic, its cultural relevance is beyond debate, as in addition to the headliners, the supporting cast included Peter Falk, Eddie “Rochester” Anderson, the 3 Stooges, and the great Arnold Stang.  Moreover, it bears mention that the renowned director of Mad World, was Stanley Kramer, more recognized for his social dramas, including Guess Who’s Coming to Dinner, The Defiant Ones, and Judgment at Nuremberg.  With such an accumulation of talent, it comes as no surprise that Mad World received six Academy Award and two Golden Globe nominations, and is categorized by many as an all-time classic in American movie history.  The plot is full of twists and turns, but beautifully elevated, with stellar writing and acting to match: 5 strangers witness an accident, and simultaneously learn about a large sum of money hidden in a park, buried beneath a large “W,” with Durante’s last gasp.  At first, they agreed to equal shares of the $350,000, but soon each plots to recover the loot on his own, and everyone begins a mad dash with assorted partners in crime (spouses, friends, relatives, etc.) to be the first to reach the cash.  In so doing, each of five groups tries to undermine the others, and they all encounter setbacks from being locked in the basement of a hardware store, stranded on a highway with a child’s bicycle, sinking in a river, a drunken airplane pilot, and more.  (For those of you from younger generations who are Googling the names or the movie above, you might be more familiar with a newer iteration of a similar story in the movie Rat Race, starring Whoopi Goldberg, Dean Cain, John Cleese, Cuba Gooding, Jr., Cathy and Kathy Bates, among others.)

If you have not seen the movie, you certainly should, but one iconic scene essentially captures the film, a sequence in which Winters demolishes an entire gas station, mostly by hand, in several hilarious, frenetic minutes. The movie ends with all of the misguided, money hungry adventurers in the hospital with multiple injuries, but none of the treasure.  In a last, desperate (and shameless) grab for the bounty, the hapless male contingent is catapulted, one by one, from the ladder of a fire engine attempting to rescue them, as the terrified crowd below watches and the entire haul slowly floats to the now delighted onlookers.  In short, grasping for money, at the expense of ethics, morality, and intelligent planning gets you nowhere.

Procedural History

Much like the film, Paulsen has misdeeds galore, with seeming chaos at every turn, thanks to its beginning as a multi-plaintiff, misjoined complaint with a California resident, and a Georgia resident (Ms. Paulsen) bringing an action in the Eastern District of New York in April 2010. See Cardenas v. Abbott Labs., 2011 U.S. Dist. LEXIS 116879 (N.D. Ill. March 7, 2011).  Plaintiffs alleged injuries as a result of injections of the drug, and asserted negligence, strict liability, failure to warn, breach of warranty and fraud causes of action against various defendants.  In homage to the movie, it is fitting to provide aliases for the defendants using the names of the actors in the movie – because it is the plaintiff’s shenanigans that are the focus here – not the defendants’ titles and actions. Therefore, in that regard, the defendants are now dubbed Abbott Laboratories (hereinafter “Sid”), Takeda Pharmaceuticals of North America, Inc., (“Ethel”),Takeda Chemical Industries, Inc., (“Milton”) and TAP Pharmaceutical Products, Inc. (“Jonathan”) (collectively, “Defendants”). Id. at *3.  The Defendants filed a motion to dismiss, objecting to venue, so plaintiffs amended their complaint, adding New York and New Jersey plaintiffs.  Didn’t matter.  The case was transferred to the Southern District of New York. Id. Defendants again filed a motion to dismiss, and the Southern District of New York transferred the action to the Northern District of Illinois in 2011, addressing issues of venue and personal jurisdiction, and dismissing defendant “Milton” because it was not served with the complaint. Id. (but more on that later). Id. Finally, the Illinois federal court considered a substantive (Rule 12 (b)(6)) motion to dismiss, and found that plaintiffs provided “nothing but the fact that [they] received Lupron injections ‘on several occasions.’” Id. at *12-13.  For example, the complaint failed to indicate “whether Plaintiffs [were] women, nor [did] it establish whether Lupron was prescribed to Plaintiffs” for on- or for off-label use.  All these omitted facts were, obviously, “particularly within Plaintiffs’ control.” Id. Therefore, the court dismissed the complaint, with leave to amend to allow plaintiffs to put “some minimal amount of flesh” on their bare-bones allegations. Id. at *13-14.

Plaintiffs filed an amended complaint in October 2011, and discovery commenced, but with Paulsen the only remaining plaintiff, in August 2013 her counsel moved to withdraw. See Paulsen, 2018 U.S. Dist. LEXIS 50256, at *8.  The judge granted the motion, allowing plaintiff 30 days to file an appearance.  That didn’t happen either.  The action was dismissed for lack of prosecution in October 2013 after plaintiff failed to appear. Id.

Plaintiff’s Second Action

Undeterred, plaintiff filed a new complaint on May 11, 2015, alleging claims for negligence, strict product liability, failure to warn, breach of warranty, and fraud against “Sid”, “Ethel”, “Milton” and “Jonathan”. Id. at *9.  Plaintiff alleged that she had been injected with Lupron twice for on-label treatments, and had suffered various injuries, all of which occurred in Georgia. Id. at * 3-4.  Defendants moved to dismiss, claiming that the lawsuit was untimely and seeking application of the six-month limitation in Georgia’s savings statute [Ga. Code Ann. § 9-2-61(a)], while plaintiff maintained that Illinois’s one-year period governed the issue, 735 ILCS 5/13-217.6. Id. at *10.  After determining that the only Illinois citizen, Sid, was a real party in interest (a dispositive issue, because if not, Georgia’s statute controlled time-barring the case), the judge denied the motions to dismiss without prejudice. Id. at *10-11.

Dismissal of Milton and Jonathan

Defendants resubmitted their motions to dismiss in April 2017, arguing that Milton and Jonathan were not properly served, an interesting issue that itself could be the subject of its own post. Id. at *17-18.  Suffice it to say that the court ruled that service on Jonathan’s surviving corporation (because Jonathan no longer existed at the time the case was originally filed in 2010) was improper because in essence, “[p]laintiff cannot effectively serve one corporation by serving a completely different corporation.” Id. at *19, 25.

As to Milton, the court did not reach the service issue because plaintiff voluntarily dismissed Milton on July 9, 2011, − but refiled the action, again, on May 11, 2015, well outside the one-year limitation of Illinois’s savings statute. Id. at *26-27.  Thus, the court dismissed the claims against Milton with prejudice. Id. at *27.

Rule 12(b)(6) Motion

At long last, the court turned to the Rule 12(b)(6) motion to dismiss for failure to state any cognizable claims, pursuant to TwIqbal.  By now, it should hardly surprise anyone (even plaintiff herself, one would think) that the claims were almost all poorly pled, and most were dismissed.  For example there was “nothing in the complaint that connect[ed] Ethel to Jonathan and its alleged responsibility for Lupron-related activities beyond their shared parent company.” Id. at *30.  The familiar catchall of “Defendants” failed to state a plausible claim against Ethel and was “therefore insufficient to satisfy Rule 8’s pleading the claims,” resulting in the court’s dismissal of all claims without prejudice. Id.

Merits of Plaintiff’s Causes of Action

Turning to the merits, court next conducted a choice of law analysis, using Illinois’s “most significant relationship test” to determine whether Illinois or Georgia law applied. The court ultimately decided that Georgia law would apply, largely because plaintiff resided in, and suffered her alleged injuries in that state, which had the strongest interest in the litigation. Id. at *35-37.

After determining that plaintiff sufficiently alleged that Sid played a role in manufacturing Lupron beyond its ownership of Jonathan, the court declined to dismiss strict products liability and failure to warn claims against Sid. Id. at *40.  However, it ruled that plaintiff’s allegations that Sid failed to adequately test the product before approval, did not advise “Plaintiffs and their physicians,” and misrepresented “the dangers associated with the use of Lupron,” failed to allege either that Sid owed or breached a duty to plaintiff. Id. at *45.  The allegations could not support plaintiff’s negligence claims against that defendant. Id. Nor could plaintiff state a claim for express warranty through statements that Defendants “expressly represented” that Lupron was “safe and efficacious,” “safe and fit for its intended use,” or “of merchantable quality.” Id. at *46-47.  In dismissing plaintiff’s claim, the court observed that “Plaintiff [did] not identify any specific warranty that Sid made to her … “nor [did] she identify the content of any statement by Abbot.” Id. at *47.  Similarly, plaintiff’s breach of implied warranty claim failed because she could not establish privity – as the complaint stated only that she used Lupron, and was devoid of allegations “that she purchased it.” Id. at * 49.

Further – and utterly unsurprisingly by this point − plaintiff’s fraudulent misrepresentation claim was not pled with the heightened particularity required by Rule 9(b), “[t]he who, what, when, where, and how: the first paragraph of any newspaper story.” Id. at *50 (citation omitted).  Rather, the complaint merely claimed that Defendants generally misrepresented the product’s safety in its labeling, marketing, and advertising over several decades. Id. However, plaintiff failed to articulate “who made these statements (other than Defendants, without specifying which Defendant made which statement), where and when these statements were made (other than to say sometime in the 1990s-2000 in Georgia and elsewhere), or how exactly Lupron’s safety was misrepresented.” Id. at *51.  Finally, her negligent misrepresentation claim was also doomed absent “allegations pointing to [defendant’s] statements on which Plaintiff relied” prior to her Lupron injection. Id.  Therefore, the court concluded that plaintiff’s negligent misrepresentation claim could not proceed “under Rule 8’s pleading standard,” and it too, was dismissed. Id. at *52-53.

In a nutshell, plaintiff ran afoul of every tenet of basic pleading 101 by repeatedly offering only threadbare allegations without specific facts; generalized and conclusory allegations leveled only at “Defendants;” and rote recitations of the elements of a claim without the facts to support it. However, to our chagrin, and much more to that of the Defendants, the court dismissed all of plaintiff’s claims, except for strict product liability and failure to warn, with leave to amend, despite seven years of failed pleadings. Id. at *54.  At least, the court issued plaintiff a none too subtle warning, stating it was “cognizant of the long procedural history,” and conditioning its leave for plaintiff to file an “amended complaint consistent with this opinion, if Plaintiff believes that she can overcome the deficiencies identified above for the dismissed claims.” Id. at *55 (emphasis added).

Given Plaintiff’s history of inartful pleading, repeated procedural errors, and other tactical blunders, one can expect, and hope, that like the buffoons in “Mad World,” when this case finally does end, plaintiff and her attorneys will wind up empty-handed.

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

It may be post Mardi Gras season, but we don’t think there is ever a bad time to embrace the motto – “Laissez les bons temps rouler.” Quite literally – “Let the good times roll.” However, don’t try this with your high school French teacher, because after her gasp of horror, she will tell you that the grammatically correct way to get a party started in France is “Prenons du bons temps.” Of course, the Louisiana version is really Cajun French as opposed to France French and with both having so many good things to offer it’s really a matter of preference in a given moment. Like deciding if you’re in the mood for bouillabaisse or crawfish etouffee; a beignet or a croissant; a Hurricane or a Cabernet Franc.

Now that we’ve got you thinking about what’s for dinner, we can narrow our Louisiana focus to just the Louisiana Products Liability Act (“LPLA”) – hoping to whet your legal appetite now. In the case of Pierre v. Medtronic, Inc., 2018 U.S. Dist. LEXIS 67773 (E.D. Lous. April 23, 2018), plaintiff alleged she was injured as a result of defendant’s self-fixating mesh that was used in plaintiff’s abdominal surgery. Plaintiff alleges she suffered an infection and pain following her surgery. Id. at *2. We are jumping to the end of the decision to immediately lop off several of plaintiff’s claims. The court dismissed claims for breach of warranty of fitness for ordinary use, negligence, breach of implied warranty, negligent misrepresentation, and negligent design all on the grounds that they exceed the scope of the LPLA and the LPLA “sets forth the exclusive theories of liability for manufacturers for damage caused by their products.” Id. at *15.

So, what claims does the LPLA allow? Manufacturing defect, design defect, failure to warn, and express warranty. Id. at *5. And on defendant’s motion to dismiss, only half those claims survived. The first claim to survive, unusual for a drug/device case, is for manufacturing defect. That’s because here plaintiff had a specific allegation that the mesh used in her surgery was improperly sterilized which led to her development of an infection. Because plaintiff is challenging a deviation from the standard procedures for this product, she’s stated a claim for a manufacturing defect. But the court was clear that what plaintiff could not do is attack the defendant’s sterilization process generally, only this particular alleged deviation. Id. at *7-8.

Next plaintiff alleged two design defects. First plaintiff alleged that the mesh was defective in that it was made of polyester, a weaker material than used in other mesh products, and that the weaker material required a different method of being secured which ultimately led to causing plaintiff more pain than she would have suffered with a different method of attachment. Id. at *8-9. Since plaintiff alleged a design defect, alleged that that defect was the cause of one of her injuries (pain), and that alternative designs existed, she passed TwIqbal on this claim. Her second design claim, however, did not meet that standard. Plaintiff alleged that the design of the mesh caused her infection by lowering her pH. But missing from this claim is any suggestion of “the existence of a feasible alternative design that would prevent the alleged injury.” Id. at *10.

There was no splitting the baby on plaintiff’s failure to warn claim. It was dismissed in its entirety. As to the alleged failure to warn about infection, plaintiff relies exclusively on a single marketing document. However, plaintiff failed to allege any facts “to plausibly suggest that [plaintiff’s] surgeon relied, or any competent surgeon would rely, on this marketing document when deciding whether to perform surgery.” Id. at *11. A pretty demanding standard when you infer, and we think the court was so implying, that no competent surgeon relies on marketing material to make medical decisions. Moreover, the court pointed out several ways in which the marketing document cites to other documents, most importantly to the “Instructions for Use” of the mesh demonstrating that “Defendants did not rely solely, if at all, on the marketing document to warn users of the risks.” Id. at *12. Not to mention that the risk of infection is a “common surgical complication” most likely already known to plaintiff’s surgeon. Id.

Plaintiff’s second failure to warn claim was based on a failure to warn that the mesh might contract after surgery causing pain. Id. Here plaintiff failed to allege any facts about what warning was provided to plaintiff’s surgeon relying only on a boilerplate statement that defendant didn’t warn. Id. But such an “allegation is too broad to state a claim because it does not identify (1) which aspects of the product warranted a warning and (2) what injuries resulted from the failure to warn.” Id. at *13. Too vague to withstand dismissal.

So too was plaintiff’s breach of express warranty claim. Plaintiff only alleged that defendant warranted the product was safe and fit for its intended use, merchantable, adequately tested, and did not have dangerous side effects. Id. at *14. But a claim that a product is “safe” or “effective” is only a “general opinion” or “general praise,” insufficient to form the basis for an express warranty under the LPLA.

Of the 6 claims brought that were permissible under the LPLA, only 2 survived the motion to dismiss. Not a complete win, but good enough to put in the “good times” category. And if you don’t want to get embroiled in the French debate, we recommend following the lead of Shirley & Lee from 1956 or The Cars from 1978 and just let the good times roll (in English).

Last week we attended our law firm’s partner retreat.  In between circuits on the lazy river, there was talk of synergies, branding, cross-selling, diversity, technology, and, mostly, collaboration.  You know – the usual stuff.  That last point, collaboration, is really the predicate for all of the others.  Collaboration today has a positive connotation of people working together to achieve a desirable result.  Collaboration came into the room with a much uglier aroma during the Second World War, of course.  See the 1969 film, The Sorrow and the Pity, for more on that sad story.  The nasty words today are collusion and conspiracy.  One is a specific criminal offense, while the other is mere invective.  But enough said about politics and criminal law.  In any event, a retreat is a perfectly fine place to discuss collaboration.  It is an opportunity for colleagues from all over the map to converge in a convivial setting to get to know each other,  trust each other, respect each other, and commit to work more closely with each other.  Luckily for us, as huge and global as our firm is, we do collaboration exceedingly well.  In fact, the very last thing that happened at the retreat was that a conference room of alpha lawyers punched into our phones real-time, word-one descriptions of the firm.  The results were instantaneously collected to create a word cloud.  Do you know what word ended up front and center and in the biggest font?  Collaboration.  So, yay.

 

Around the banquet table and around the pool there was a lot of talk about collaboration.  Law is a team sport.  It is much more like football or basketball than golf or tennis.  And yet, there is a lot of golf and tennis played at retreats, and no basketball or football.  A paradox?  Not really.  Even our golf and tennis games typically involve two-person teams – sort of like trial teams in the courtroom.   Collaboration is by no means limited to the partnership, even if the term partnership is peculiarly evocative of collaboration.  Tomorrow’s partners are today’s associates and counsel.  Unless we develop their talents and permit them to flourish, the law partnership’s institutional survival is a frail thing.  When we were laboring in our mid-associate years, there was a partner who was especially supportive.  He was generous with advice and generous with praise.  He used to say, “I need you to succeed, because you’ll be paying my pension someday.”  That was back in the days of defined benefit plans, which hardly exist anymore.  Nowadays, in the you’re-on-your-own economy,  we save up for our own retirements, so institutional survival perhaps does not seem as vital as it once was.  Surely, there is a cost to that transformation.  But forget about retirement – every law firm exists on a razor’s edge of intellectual supply and demand.  What Samuel Goldwyn said about movie studios is also true for law firms: it’s scary to think that the assets go home every night.  Without constant renewal from young lawyers who bring competence, commitment, and creativity, a law firm won’t live to see the next quarter. Further, the people who do so many of the things that keep the operations humming are the non-lawyers.  They are just as important and professional as the folks with J.D.s.  They often have the most to say about whether we will have a good or bad day.  And if we want to have an in-depth debate about whether the latest Star Wars movie made sense, we are far more likely to check in with some of our friends in IT than with other Life Sciences lawyers.  The constant collaboration animating our firm makes us better at what we do and happier about our lives. 

 

So far we have been talking about internal collaboration.  But it is more and more the case that mass tort lawsuits force firms to collaborate with others to mount vigorous and effective defenses of their clients.  Sometimes one client will assemble a virtual law firm, doling out different tasks to different firms.  (Pity the firm charged with responsibility for overseeing electronically stored information.  Talk about no-win propositions!) Sometimes codefendants need to align to thwart the predations of plaintiffs who seek to exploit potential fissures and induce the defendants to point fingers at each other, thereby doing much of the plaintiffs’ work for them.  Again, we count ourselves lucky to work in a firm that enjoys both the reputation and reality of playing nicely in the sandbox with others.   Sharp elbows simply aren’t a part of our culture.  There is no reason to horn in on others’ work, and certainly no reason to trash the effort of colleagues, even when they are competitors in the marketplace.  For one, that sort of backbiting does not work.  Clients hate it.  It reminds us of how our elementary school teachers used to tell us that they could see everything that happens in the classroom, every passed note, spitball, and droopy eyelid.  Naturally we doubted that at the time.  But then 20 years later we became a high school teacher and – what do you know – it was totally true that everything in the classroom was laid out in front of us with deep focus and clarity.  It’s the same with clients.  They see how their law firms cooperate or collide.  They hear every snide complaint, and it drives them crazy.  We once knew of two partners who would call the client to complain, not only about how other firms were allegedly shirking their responsibilities, but also about how much better they were than their ‘partners’ at the same firm.  Nice.  Guess what the client did?  She called up another partner at the firm and asked why he bothered to work with partners who were so insecure and disruptive, and also asked why the client should continue to employ a firm that brought too much chaos to the party. Good questions.   

 

One of our colleagues at the retreat told us about a trial last year that ended in a hung jury.  The result ended up not being so bad, as it was followed by a favorable settlement not long afterwards.  But our co-counsel saw the result as a cue to second-guess several trial decisions, such as doing a short opening statement, deciding not to call an expert witness they had worked up, and deploying ‘only’ 37 slides in the closing.  We know it was bad form for the other law firm to engage in such self-indulgent revisionism, but even beyond that, knowing nothing about the case, we suspect that the criticisms were unfounded.   As we mentioned in our post two weeks ago about our recent jury duty, we harbor deep doubts that overlong presentations with superabundant graphics are the best way to pierce a jury’s confusion and indifference.  The older we get, the more convinced we are that simpler and shorter are better.  (We’d dance a jig if depositions were shortened from seven hours to five,  if opening statements were capped at 30 minutes and closings at an hour, and if legal briefs were limited to 20 pages.  But we digress.)  And then we heard that the hypercritical colleague from another firm espoused more “fulsome” presentations.  That did it.  Now arose our antediluvian, pedantic hatred for the use of “fulsome” as a faux benign synonym for “full” or “complete,” when it really means “excessively flattering.”  By “really means” we mean that “fulsome” should be confined to its proper 1663 denotation.  Do not fight us on this one.  Consult the OED or Fowler’s.  Garner is mostly on our side here, though he calls “fulsome” a “skunked term” because the loose sense is now so common.  We don’t like skunks.  The philistine encroachments of the latter part of the last century and the early jabberings of this one do not persuade us.  Hmmm.  Perhaps there are limits to our own ability to collaborate.   And please do not get us started on the current fashion of beginning almost every answer with the word “So,” no matter how nonsensical. 

 

By the way, while we are talking about collaboration among law firms, we ought to acknowledge that this blog has always been a collaborative effort among lawyers from different, often competing, law firms.  It is possible that this fact makes the Drug and Device Law blog unique among Big Law blogs.      

 

Just before we left for the retreat, we got a call from a client who asked us to parachute in and do a product liability trial for them.  There was a catch.  The case had been worked up by another firm, discovery was closing in a week, and the other firm would file all the summary judgment papers and handle the experts.  All we would do is work up motions in limine, prepare for trial, and then do our parts of the trial.  Was that okay?  Ha! – that wasn’t just okay, that sounded splendid.  We couldn’t stop ourselves from telling the client that it sounded like just about the most perfect assignment we could ever get.  We were getting in on the fun bits.  Not only would we gladly take on this assignment, but we would offer gratis a profound promise:  not once would we utter a word of complaint about what had been done in the case before our arrival.  No mutterings about ‘why didn’t they depose the mother?’ ‘why didn’t they hire a better expert?’ ‘why didn’t they file a motion based on x?’ etc.  We are betting the other firm had its reasons for doing what it did.  Whatever.  What’s the use in whining?  Let’s treat this case as an exemplar for all litigation which is, in turn, an exemplar for the whole world.  Let’s take what’s given to us with gratitude and make the best of it.   We’re happy to join the team.  Maybe it took us a while to realize it, but practicing law can be a joy, but not so much when it is a solo activity.  The success and joy of it lies in collaboration.

 

 

Last September, we criticized a 2-1 decision out of the Ninth Circuit, In re Google Referrer Header Privacy Litigation, 869 F.3d 737 (9th Cir. 2017), calling it a “poster child” for cy pres abuse in class actions.  Read the entire post for all the gory details, but briefly, the class action settlement in Google Referrer:

  • Let counsel have a whopping 38% of the settlement as fees.
  • Declared the entire settlement “non-distributable” because, even without opposition, neither the class members nor their damages could be determined.
  • Gave 100% of the settlement funds as cy pres to six uninjured charities, and 0% to the 129 million estimated supposedly injured class members.
  • All three of the law school cy pres recipients had ties to counsel in the case.
  • The cy pres recipients were to educate and publicize supposed internet privacy issues – in other words, to act as a breeding ground for further litigation of this sort.

We closed that post by recommending, “[w]e think this is a case that should go to the United States Supreme Court.”  We don’t say that often (only about DesianoNeurontinBartlett, Bristol Myers-Squibb, and Fosamax, that we can recall offhand) – six times in eleven years.

Well, we’re pleased to report that yesterday the United States Supreme Court accepted a certiorari petition in the case, rechristened as Frank v. Gaos, No. 17-961, 2018 WL 324121 (U.S. Apr. 30, 2018).  The SCOTUSBlog story is here.  The order granting certiorari is here.  The question presented is:

Whether, or in what circumstances, a cy pres award of class action proceeds that provides no direct relief to class members supports class certification and comports with the requirement that a settlement binding class members must be “fair, reasonable, and adequate.”

See Certiorari petition.  We are cautiously optimistic that the result in Frank will be the disavowal or severe limitation of cy pres distributions in class actions.

The Eleventh Circuit has lately become a bit like Forest Gump’s box of chocolates—you never know what you’re going to get. The news today is positive.  The Eleventh Circuit recently issued a gem of an opinion on the learned intermediary doctrine under the law of Alabama, which also happens to be the home of the aforementioned Mr. Gump.

The Eleventh Circuit is not always so good. While the court got everything right in Tutwiler v. Sandoz, Inc., No. 17-13985, 2018 WL 1719024 (11th Cir. Apr. 9, 2018), readers of our 2017 Ten Worst post will recall that the Eleventh Circuit issued three of the ten worst drug and device opinions of 2017, making it 2017’s most noteworthy performer among the circuits.  Maybe we can read something into that.  Or maybe it was fate, like a feather floating in the wind.  After all, if Forest Gump taught us anything, it was that history is arbitrary and that sometimes bad things happen to good people.  The latter, of course, is a reference to Forest’s hard-luck childhood friend Jenny, played beautifully by a young Robin Wright in a performance that was both poignant and memorable.  (Much different, by the way, from Wright’s more recent portrayal of an Amazon warrior in 2017’s reboot of Wonder Woman, which awkwardly fell flat in what was otherwise a perfectly decent superhero film.  We have not yet binged the last season of House of Cards on Netflix, so we will withhold comment on Wright as the relentlessly power-hunger President Claire Underwood.  But we digress.)

So what flavor did the Eleventh Circuit recently give us on the learned intermediary doctrine? A good one, or two, or even three.  In Tutwiler, the plaintiff alleged that she suffered pulmonary issues as a result of taking generic amiodarone for non-life threatening atrial fibrillation.  2018 WL 1719024, at *1.  According to the plaintiff, she did not receive the patient Medication Guide that the manufacturer allegedly made available to distributors and thus did not know that her doctor prescribed the drug off label. Id.

The district court dismissed the plaintiffs’ failure-to-warn claims on two bases: (1) federal regulation of generic drug warnings impliedly preempted the state-law warnings claims and (2) the learned intermediary doctrine barred the plaintiff’s claims absent allegations that inadequate warnings to the physician proximately caused the alleged injury. Id..  The Eleventh Circuit affirmed under the learned intermediary doctrine.  This is slightly surprising, given that the Supreme Court’s opinion in PLIVA v. Mensing provides such a clear path to implied preemption in failure-to-warn claim involving generic drugs.

Regardless, the Eleventh Circuit’s opinion on Alabama’s learned intermediary doctrine is in equal parts concise and well reasoned. There are three takeaway points. First, the plaintiff alleged that her physician prescribed the drug off label.  But that did not make a difference to her failure-to-warn claims, nor should it have made a difference.  We have seen other plaintiffs try to establish or amplify failure-to-warn claims by highlighting that their physicians prescribed drugs off label.  It usually does not work, for the simple reason that a prescription drug manufacturer has a duty to warn about known and reasonably knowable risks, not uses.  Of course, some states’ laws might impose a duty to warn regarding dangers of a product’s foreseeable misuse.  Be that as it may, a bare allegation of off-label use does not an inadequate warning make.

Second, and most importantly in our view, the Eleventh Circuit rejected the argument that the learned intermediary doctrine did not apply because the drug manufacturer did not adequately warn the plaintiff’s physician—and all other physicians—of the drug’s dangers.  In other words, the physician lacked sufficient information to be considered a “learned” intermediary. Id. at *3.

We have seen this argument before too, and a small number of courts have regrettably fallen for it. It is nonsense.  The learned intermediary doctrine is not so named because drug and medical device manufacturers have a duty to create “learned intermediaries.”  The manufacturer’s duty is to warn about a product’s known and knowable risks, and the learned intermediary doctrine defines to whom that duty is owed—highly educated physicians who are already “learned.”  This in turn defines the two critical elements of a warnings claim in drug and medical device cases:  (1) whether the warnings are adequate and (2) whether any inadequacy in the warnings caused the alleged injury.  Those elements are defined by reference to a reasonable physician’s skill and knowledge (his or her “learnedness”) and the warnings’ impact on the prescribing physician’s conduct.

The Eleventh Circuit explained it this way:

[I]n Alabama, the manufacturer’s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the use of its product. The adequacy of the manufacturer’s warning is “measured by its effect on the physician, [ ] to whom it owed a duty to warn, and not by its effect on the consumer.”

. . . . In such a situation [where the patient alleges inadequate warnings] the patient must show that:  “[T]he manufacturer failed to warn the physician of a risk not otherwise known to the physician and that the failure to warn was the actual and proximate cause of the patient’s injury.  In short, the patient must show that, but for the false representation made in the warning, the prescribing physician would not have prescribed the medication to his patient.”

Id. at **2-3 (citations and quotations omitted).  In Tutwiler, the plaintiffs alleged that the drug warnings were insufficient, but that alone does not erase the learned intermediary doctrine.  She also had to allege causation.  That is where she failed:

On appeal Ms. Tutwiler again argues that the learned intermediary doctrine does not apply because she alleged that [the manufacturer] did not adequately warn Dr. Plumb. This argument, however, does not address Alabama’s separate requirement that she also plead proximate causation—that Dr. Plumb would not have prescribed her amiodarone had he known of its dangers.

Id. at *3.  Because the plaintiffs did not allege that different or additional warnings would have changed her physician’s prescribing physician, she failed to allege causation, and the learned intermediary doctrine barred her claim. Id.

Which brings us to our third takeaway.  The plaintiff could not avoid the learned intermediary doctrine by alleging that she would have avoided the drug had she known of its dangers.  “Regardless of what Ms. Tutwiler would or would not have done with the information, Alabama law requires a showing of what Dr. Plumb would have done with it.” Id. (emphasis in original).  Plaintiffs routinely give self-serving testimony or execute affidavits attesting that they would not taken the drug “had they known.”  That won’t work, at least not in Alabama.

The opinion’s only drawback is that it is not published. Still, the Eleventh Circuit has set a tone that we hope will continue throughout 2018 and beyond.  Run Forest Run.

Not quite two years ago, the United States Supreme Court did something that we liked a lot – it abolished the so-called “presumption against preemption” in express preemption cases. It did that in a bankruptcy case, Puerto Rico v. Franklin-California Tax-Free Trust, 136 S. Ct. 1938 (2016) (“Franklin”), so it took a little while before we found out about it.  Once we did, we immediately let the word be known:

The plain text of the [preemption clause] begins and ends our analysis. Resolving [the question] for purposes of the pre-emption provision begins “with the language of the statute itself,” and that “is also where the inquiry should end,” for “the statute’s language is plain.”  And because the statute “contains an express pre-emption clause,” we do not invoke any presumption against pre-emption but instead “focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.”

Id. at 1946 (emphasis added).

Now, when the Supreme Court makes a holding like that about preemption, that should be the end of the matter.  But as we’ve pointed out many times before, strange things tend to happen when preemption mixes with state-law product liability actions.  So, now that nearly two years have passed, how well has the Supreme Court’s abolition of the presumption against preemption in express preemption cases been respected by the lower courts?

Generally, the courts have followed the Supreme Court’s lead.  The Ninth Circuit, which sometimes has had to be reigned in by the Court, did not stray on this issue.  In Atay v. County of Maui, 842 F.3d 688, 699 (9th Cir. 2016), a preemption case involving genetically modified foods, the court placed the abolition of the presumption against preemption among its “federal preemption principles”:

Where the intent of a statutory provision that speaks expressly to the question of preemption is at issue, “we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.”

Id. at 699 (quoting Franklin).  With no adverse presumption, the state action in Atay – an attempt to ban the growing of anything genetically modified – was held preempted.  Id. at 702-03.

The Eighth Circuit in Watson v. Air Methods Corp., 870 F.3d 812, 817 (8th Cir. 2017), also followed Franklin:

In determining the meaning of an express pre-emption provision, we apply no presumption against pre-emption, and we “focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.”

Id. at 817.  Finding the text of the relevant statute (involving airline deregulation) “highly elastic and so of limited help,” id. (citation and quotation marks omitted), Watson concluded that the plaintiff’s wrongful discharge claim was “too tenuous, remote, or peripheral to [be] expressly pre-empted.  Id. at 818.

In EagleMed LLC v. Cox, 868 F.3d 893, 903 (10th Cir. 2017), another airline deregulation case, the court found that air ambulance services were governed by the statute, and therefore state worker’s compensation claims against them were expressly preempted.  As for any presumption against preemption:

[W]hen a statute contains an express preemption clause, “we do not invoke any presumption against pre-emption but instead focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.”  And when the statute’s language is plain, our inquiry into preemption both begins and ends with the language of the statute itself.

Id. at 903 (citing Franklin).  Because not “a single textual reason” was offered in opposition to preemption, the state claims failed.  “[P]olicy reasons cannot trump the plain language of the statute.”  Id. at 904.

More directly applicable to what we do, Conklin v. Medtronic, Inc., __ P.3d __, 2017 WL 4682107 (Ariz. App. Oct. 19, 2017), likewise recognized the demise of the presumption against preemption in a medical device product liability case.  “While federal laws are presumed not to preempt state laws, courts do not invoke that presumption when the federal statute contains an express preemption clause.”  Id. at *2.  In addition to Franklin, Conklin cited the four-justice dissent in Cuomo v. Clearing House Ass’n, L.L.C., 557 U.S. 519, 554 (2009) (“There should be no presumption against pre-emption because Congress has expressly pre-empted state law in this case.”), and the absence of any application of a presumption against preemption in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  Every product liability claim except allegations of failure to make FDA-required reports was held preempted in Conklin.

Federal district courts have reached the same result.  In In re Smith & Nephew Birmingham Hip Resurfacing (BHR) Hip Implant Products Liability Litigation, the MDL judge recognized that “[r]ecently, the Supreme Court explained that a court should not apply a presumption against preemption when a ‘statute contains an express pre-emption clause,’” and did “not rely on a presumption against preemption”  not that it seemed to make much difference.  ___ F. Supp.3d ___, 2018 WL 1471684, at *6 n.8 (D. Md. March 26, 2018).  Another unbound court, Olmstead v. Bayer Corp., 2017 WL 3498696, at *3 n.2 (N.D.N.Y. Aug. 15, 2017), declared that, after Franklin, assertion of presumption against preemption in express preemption was “frivolous”:

Plaintiff’s argument that there is a strong presumption against preemption and that this presumption applies to the MDA’s express preemption clause is frivolous.

Id. at *3 n.2 (Franklin citation and quotation omitted).  Medical device-related claims were preempted.  Another New York court, Canale v. Colgate-Palmolive Co., 258 F. Supp.3d 312 (S.D.N.Y. 2017), pointed out in another FDCA case, that the plaintiffs’ assertion of an “assumption” that common-law claims were not preempted was contrary to law:

Defendant correctly points out that where, as here, Congress has expressly manifested its intent to preempt state law, no presumption against preemption arises.  [Franklin citation omitted]   Rather, courts “focus on the plain wording of the clause, which necessarily contains the best evidence of Congress’ preemptive intent.”

Id. at 319 (quoting Chamber of Commerce of the U.S. v. Whiting, 563 U.S. 582, 594 (2011)).

The following bound courts – from the Ninth and Tenth Circuits, also rejected any presumption against preemption in reliance on Franklin.  In re Chrysler-Dodge-Jeep Ecodiesel Marketing, Sales Practices, & Products Liability Litigation, ___ F. Supp.3d ___, 2018 WL 1335901, at *43 (N.D. Cal. March 15, 2018); Kaiser v. CSL Plasma Inc., 240 F. Supp.3d 1129, 1135 (W.D. Wash. 2017) (implied preemption case); In re Bard IVC Filters Products Liability Litigation, 2017 WL 5625547, at *4 (D. Ariz. Nov. 22, 2017); In re Syngenta Ag Mir 162 Corn Litigation, 2016 WL 4382772, at *3 (D. Kan. Aug. 17, 2016).

Finally, as an example proving our prior proposition that strange things happen when preemption and product liability mix, the Third Circuit in Shuker v. Smith & Nephew, PLC, 885 F.3d 760, 771 n.9 (3d Cir. 2018), so far uniquely, decided that it wasn’t going bound by the Supreme Court’s decision in Franklin.  Unless and until the Supreme Court rejects the presumption in a product liability case, the Third Circuit will continue to apply it – everybody else be damned:

We disagree with [defendant’s] assertion that “[a]ny presumption against express preemption no longer exists.”  [Defendant] relies on [Franklin] . . . but that case did not address preemption of claims invoking “historic . . . state regulation of matters of health and safety,” such as the products liability claims at issue here.  As [Franklin] does not “directly control[ ]” here, we “leav[e] to [the Supreme Court] the prerogative of overruling its own decisions,” Agostini v. Felton, 521 U.S. 203, 237 (1997), and continue to apply the presumption against preemption to claims, like those in this case, that invoke “the historic police powers of the States,”

Shuker, 885 F.3d at 771 n.9 (citations to Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) omitted).

Just like that, without acknowledging either: (1) that the Supreme Court had already refused to apply a presumption against preemption to the same preemption clause in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); or (2) that its ruling was in conflict with every other court of appeals decision to rule on the question, Shuker chose to ignore an on-point Supreme Court decision that was less than two years old.

Moreover, the Shuker panel evidently went where even the Shuker plaintiffs were loath to go.  The plaintiffs in their two briefs (there were cross-appeals in Shuker) didn’t even attempt to argue a presumption against preemption. See Brief of Appellants, 2017 WL 413755 (3d Cir. filed Jan. 23, 2017); Reply Brief of Appellants to Brief of Appellee Smith & Nephew, Inc., 2017 WL 2211289 (3d Cir. filed May 8, 2017).  Heck, plaintiffs in Shuker didn’t even cite Lohr.  We keep thinking appellate judges should know better than to do things like this, and perhaps they do, but strange things happen when preemption meets product liability.

On Wednesday, the Fifth Circuit was finally able speak to what’s been going on in a Dallas courtroom that has racked up over $1.7 billion—that’s billion—in jury verdicts over the last two years in the Pinnacle Hip Implant MDL. And the Fifth Circuit entered the room loudly. It ordered a new trial of the plaintiff’s very first victory, the one that produced a half-billion dollar verdict. The court did not hold back, making it perfectly clear that it vacated the judgment due to “the district court’s evidentiary errors and [plaintiffs’ attorney Mark] Lanier’s deception.” Slip Op. at 6.

The “evidentiary errors” have been a controversial part of these MDL trials since the time of our first post about them two years ago. Even then, we were struck by the “number and nature” of these evidentiary rulings, which in the aggregate suggested “an almost uninterrupted flow of unduly prejudicial and irrelevant information to the jury.”  The Fifth Circuit now agrees, highlighting two of them as the basis to order a new trial.

First, the Saddam Hussein evidence. Slip Op. at 43-46. That’s right. The court allowed evidence concerning Saddam Hussein into a hip implant trial. Its decision was based on a deferred prosecution agreement, one in which J&J took responsibility for the actions of affiliates who had bribed officials in the Iraqi government. These affiliates had nothing to do with the Pinnacle Hip Implant device. Regardless, after defendants elicited testimony on their own positive internal culture and marketing, the district court ruled that the defendants had thereby “opened the door” to Saddam Hussein, the deferred prosecution agreement and all sorts of other stuff. With light now green, the plaintiffs’ attorney thereafter featured Saddam Hussein and bribes and prosecution in his questioning of witnesses and closing argument. Mind you, this was a hip implant medical device trial.

The Fifth Circuit rejected the trial court’s “open door” ruling. It held that “the rules of evidence do not simply evaporate when one party opens the door on an issue.” Id. at 44. Prior bad acts cannot be used to convince a jury that defendants acted as wrongdoers in the case before it. Id. The Fifth Circuit held, however, that the plaintiffs’ attorney asked the jury to do just that. To illustrate this, the Fifth Circuit quoted the paragraph below from plaintiffs’ closing argument. Note that the italicized emphasis in the paragraph was placed there by the Fifth Circuit, as was the single word “Indeed” after that paragraph:

If you go back and look at the DPA, that’s the deferred prosecution agreement where the company paid money one time because of kickbacks to doctors in America, the other time because of the bribes to Saddam Hussein’s government, the bribes in Greece, Romania, Poland and other places where they were bribing people to put in . . . their products. The DPA has [J&J] admitting its responsibility in it. J&J is admitting that they’re responsible. They have already taken this issue out of your hands realistically. That alone is a winner. . . . [J&J] has admitted their responsibility for this. That ought to be enough.

Indeed.

Id. at 45. The Fifth Circuit wrote that this closing argument and the earlier questioning “tainted the result by inviting the jury to infer guilt based on no more than prior bad acts . . . . That alone provides grounds for a new trial.” Id.

The second evidentiary ruling rejected by the Fifth Circuit was the trial court’s decision to allow plaintiffs to use hearsay in a resignation letter from a DePuy employee alleging racism within the company. Slip Op. 46-48. Again, this was a hip implant trial. Calling it a “spectacle,” the Fifth Circuit ruled that reading this letter to the jury “refocused its attention on serious, and seriously distracting, claims of racial discrimination that defendants had no meaningful opportunity to rebut via cross-examination. This spectacle fortifies that a new trial is required.”

These evidentiary rulings alone were enough to upend the judgment. But there were more. As we laid out in our previous posts, the trial court made multiple other questionable evidentiary rulings that allowed questioning and argument on things like suicide, cancer, connections to the tobacco industry, transvaginal mesh suits, and so on. Having already overturned the judgment, the Fifth Circuit declined to address these other evidentiary rulings. But it did warn the trial court to “weigh carefully the application of Rule 403 and 404(b)” when considering these issues at future trials. Slip Op. at n. 71.

Next, the Fifth Circuit found additional grounds to overturn the judgment due to what it called “deception” by the plaintiffs’ attorney regarding plaintiffs’ experts, something we wrote about last year. Plaintiffs classified two of its experts as “non-retained,” meaning not paid. At trial, plaintiffs’ attorney contrasted this with what he called the “bought testimony” of the defendants’ expert. The problem is, however, that plaintiffs’ experts were “bought” too. Before trial, plaintiffs’ attorney donated $10,000 to St. Rita’s Catholic School, the favorite charity of one of the two experts. More blatantly, after trial, plaintiffs paid $65,000 in total to the two experts.

It would be difficult to overemphasize how hard the Fifth Circuit came down on this, labeling it “deception.” Slip Op. at 6. The court was clearly displeased. Its opinion (see pages 49-57) is littered with snide comments. Noting that Mr. Lanier mentioned to the jury that he had shared the “best apple pie in the world” with one of the two experts, the court wrote, “St. Rita’s and the $10,000 check went unmentioned.” Id. at 50. After quoting Mr. Lanier contrasting the supposedly “bought testimony” of the defendants’ experts with the supposed “real life” testimony of his two experts, the Fifth Circuit wrote: “As between ‘real life’ and ‘bought testimony,’ [the jury] chose the former by a margin of $502 million. But that choice was a false one, manufactured entirely by Lanier.” Id. at 52.

With the unmistakable intent to drive its point home, the Fifth Circuit clarified in just about every way possible that this type of maneuvering was improper:

This is the rare case in which counsel’s deceptions were sufficiently obvious, egregious, and impactful to penetrate the layers of deference that would ordinarily shield against reversal.

Lanier’s failure to disclose the donation, and his repeated insistence that Morrey Sr. had absolutely no pecuniary interest in testifying, were unequivocally deceptive.

Lawyers cannot engage with a favorable expert, pay him “for his time,” then invite him to testify as a purportedly “non-retained” neutral party. That is deception, plain and simple.

We find, by the “clear and convincing” evidence of common sense, that Lanier misled the jury in creating the impression that Morrey Jr. had neither pecuniary incentive nor motive in testifying. Neither our double deference nor counsel’s specious reasoning can alter that conclusion.

Calculated or not, falsehoods marred plaintiffs’ victory. The Verdict cannot stand.

Got it. This lambasting by the Fifth Circuit could change the game in the Pinnacle Hip Implant MDL. Proper boundaries may now be back in place, or at least some of them. There are more appeals to come, and they involve serious procedural and jurisdictional issues that were front and center in the two trials that followed this one. In fact, there may be more to come from this opinion, at least from us, as it also granted DePuy judgment on two plaintiffs’ failure to warn claims and J&J judgment on plaintiffs’ aiding and abetting claims—something for us to address another day.

One thing is already clear from this opinion, though. Two years of this MDL may have been wasted on defective jury trials. But, if a reset is needed, it must be done. The goal of an MDL is not to hammer defendants with every possible negative piece of evidence, relevant or not, so as to produce large verdicts. It is to establish a framework under which the parties can properly litigate and value the hundreds or thousands of cases within a complex mass tort. The Fifth Circuit’s opinion is an important step toward that proper construct.