We’ve seen the latest affirmance of largely identical verdicts in a consolidated MDL trial in Campbell v. Boston Scientific Corp., ___ F.3d ___, 2018 WL 732371 (4th Cir. Feb. 6, 2018).  We’re not discussing Campbell’s merits today.  For present purposes, suffice it to say that the consolidation- and punitive damages-related rulings aren’t that much different from Eghnayem v. Boston Scientific Corp., 873 F.3d 1304 (11th Cir. 2017), about which we blogged, here.

More generally, both of those cases, as well as the course of the Pinnacle Hip litigation described in several of our prior posts as well as in In re Depuy Orthopaedics, Inc., 870 F.3d 345 (5th Cir. 2017) (“Pinnacle Hip”) (which we discussed, here), illustrate an adverse trend in MDLs.  That trend is to replace the traditional (if anything in MDL practice can be called traditional) bellwether trials with consolidated multi-plaintiff trials including allegations of punitive damages.  We’ve already expressed our jaundiced view towards consolidated product liability trials as inherently prejudicial against defendants, for a variety of reasons discussed in that post.  For obvious reasons, facing punitive damages is likewise not favorable to a defendant in a trial.

As our prior consolidation post discussed at some length, defendants saddled with consolidated trials in personal injury cases used to have reason to expect appellate relief.  Identical or nearly identical verdicts were considered evidence that the jury was either unable to keep multiple individual cases straight or overwhelmed by all the factual evidence, or both.  However, the recent Campbell decision, added to other recent events, makes us believe that the ability to obtain such relief has never been more questionable.

Hence, we offer an idea that has been percolating here ever since the decision in Pinnacle Hip.  We mentioned it at last December’s ACI Drug and Medical Device Litigation conference, and it was received as a good idea by most defense counsel we talked to, so here goes….

Only you can prevent multi-plaintiff consolidated punitive damages trials.

We recognize that such trials cannot always be prevented – this idea wouldn’t have worked in Campbell, for example − but MDL defendants should seriously consider limiting their so-called “Lexecon waivers,” to the extent they are willing to give them at all.

What does that mean?

Basically, Lexecon Inc. v. Milberg Weiss Bershad Hynes & Lerach, 523 U.S. 26 (1998), held that MDL judges can’t try cases transferred to them from another judicial district under the MDL statute, 28 U.S.C. §1407.  They can try cases properly filed in the same judicial district and then transferred to them as related cases (what happened in Campbell), but all other MDL trials require a Lexecon waiver of trial in the original transferor court.

The Fifth Circuit made clear in the Pinnacle Hip decision that a Lexecon waiver, like any other waiver, must be “clear and unambiguous” to be effective. Id. at 351.  Thus, we think it would be a good idea for MDL defendants to tailor any future Lexecon waivers so that they apply only to single-plaintiff trials, and exclude punitive damages.  As for consolidation, a Lexecon waiver excluding consolidation simply preserves the manner in which cases have been tried, including MDL bellwethers, for decades or longer.  As for punitive damages, bifurcating out such allegations has been commonplace in asbestos litigation, and has been employed in other mass torts as well, such as opt out cases in the Diet Drug litigation.

Even if courts seem less inclined to recognize it, everyone on the defense side knows how prejudicial multi-plaintiff consolidations and punitive damages allegations are during trials. To the extent possible, defendants should consider self-help, in the form of limited Lexecon waivers, to prevent such prejudicial procedures.

As we demonstrated in a post back in 2013, FDA compliance evidence generally − and the fact of a medical device’s clearance as “substantially equivalent” in safety and effectiveness to a predicate device under §510k of the Medical Device Amendments (now 21 U.S.C. §360c(f)(1)(A)) specifically – had for decades been admissible evidence in product liability litigation involving FDA-regulated drugs and devices.  In 2013 we found a half dozen §510k cases directly on point. Block v. Woo Young Medical Co., 937 F. Supp.2d 1028, 1047 (D. Minn. 2013); Placencia v. I-Flow Corp., 2012 WL 5877624, at *6 (D. Ariz. Nov. 20, 2012); Musgrave v. Breg, Inc., 2011 WL 4620767 (S.D. Ohio Oct. 3, 2011); Pritchett v. I-Flow Corp., 2012 WL 1340384, at *5 (D. Colo. Apr. 18, 2012); Miller v. Stryker Instruments, 2012 WL 1718825, at *9 (D. Ariz. Mar. 29, 2012); In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 1964337, at *7 (D. Minn. June 29, 2007); Corrigan v. Methodist Hospital, 874 F. Supp. 657, 658 (E.D. Pa. 1995); Strum v. Depuy Orthopaedics, Inc., 2013 WL 3184765, at *1 (Ill. Cir. March 8, 2013).

Then, in the Mesh litigation, rulings began to change the law on the premise that, because the United States Supreme Court in Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), had held that §510k clearance was not preemptive – that is, not entitling a defendant to judgment as a matter of law – it was not even relevant in product liability litigation.  This argument turned on taking a phrase from Lohr out of context:  “[T]he 510(k) process is focused on equivalence, not safety” (id. at 493) and applying it in the evidence context.  As we had pointed out, so doing was contrary to the Supreme Court’s Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), decision holding that §510(k) clearance was intended “to ensure . . . that medical devices are reasonably safe and effective.” Id. at 349-50.  Our more recent blogposts have pointed out:  (1) that the FDA now considers §510k clearance to involve considerations of safety and effectiveness, and that (for a variety of reasons) the continued viability of Lohr itself is open to question.

Nonetheless, defendants in mesh litigation have largely been deprived of well-established FDA compliance evidence, and based on the capacious abuse of discretion standard applicable to evidentiary decisions at trial, such rulings have been upheld on appeal. See Eghnayem v. Boston Scientific Corp., 873 F.3d 1304, 1317-18 (11th Cir. 2017) (discussed here); In re C.R. Bard, Inc., MDL. No. 2187, Pelvic Repair Systems Products Liability Litigation, 810 F.3d 913, 921-22 (4th Cir. 2016) (discussed here) (“Cisson”); but see Winebarger v. Boston Scientific Corp., 2015 WL 5567578, at *7 (W.D.N.C. Sept. 22, 2015) (rejecting MDL rulings and admitting §510k clearance evidence in mesh case).

Yesterday, however another MDL judge considered the admissibility of §510k evidence, and held it admissible, flatly rejecting the Mesh decisions.  See In re Bard IVC Filters Products Liability Litigation, 2018 WL 582542 (D. Ariz. Jan. 29, 2018).  In IVC Filters, Judge David Campbell allowed the defendant’s “FDA defense,” ruling that the jury should be allowed to hear about §510k devices’ FDA pedigree.  Id. at *2.  Such evidence was doubly relevant under relevant state law:

  • “Georgia courts have adopted a risk-utility analysis for design defect claims. . . . One of the many factors a jury may consider in its reasonableness determination is the manufacturer’s compliance with federal regulations.” Id. at *2 (citation omitted).
  • “The evidence is also relevant to Plaintiff’s punitive damages claim. Under Georgia law, . . . [c]ompliance with federal regulations is not sufficient to preclude an award of punitive damages, but it is probative.” Id.

Coincidentally, Cisson also purported to interpret Georgia law, but reached a diametrically opposite conclusion.

IVC Filters rejected the false equivalence between preemption and relevance, and Mesh courts’ misapplication of Lohr:

Plaintiffs note, correctly, that the 510(k) process focuses on device equivalence, not device safety.  [Lohr citation omitted]  But this does not render evidence of the 510(k) process irrelevant to the reasonableness of [defendant’s] conduct.  The FDA grants 510(k) clearance only where the device “is as safe and effective as a [predicate device] and does not raise different questions of safety and efficacy than the predicate device.” Safe Medical Devices Act of 1990, Pub. L. No. 101-629, § 12(a)(1)(A)(ii).  The 510(k) process may not speak directly to the applicable standard of care . . ., but it does have probative value in the determination of this action.

Id. at *2 (citation omitted).  See also Id. at *3 n.2 (a preemption decision does “not address[] any evidentiary issue” and even as to preemption “the 510(k) process can in some circumstances preempt state law claims”) (citations omitted).

The excuses given for exclusion in Cisson, the jury giving clearance undue weight and a possible “mini-trial” regarding compliance, could “be adequately addressed without excluding relevant evidence to the detriment of Defendants.”  Id. at *3.  Reasonable “time limits” for each side’s evidence would prevent FDA issues from devolving into any “mini-trial.”  Id. at *4.  On the merits:

Both sides, through appropriate expert testimony or other admissible evidence, will be permitted to tell the jury about the role of the FDA in its oversight of medical device manufacturers, the regulatory clearance process for devices such as IVC filters, and [defendant’s] participation in the 510(k) process and its compliance (or lack thereof) with that process.

Id.  “[A]ny potential confusion” did not require exclusion, but only “a limiting instruction regarding the nature of the 510(k) process.”  Id. Indeed, IVC Filters correctly observed that the issue of jury confusion more likely cuts the other way – in favor of admission of FDA evidence:

[T]he absence of any evidence regarding the 510(k) process would run the risk of confusing the jury as well.  Many of the relevant events in this case occurred in the context of FDA 510(k) review, and much of the evidence is best understood in that context. Attempting to remove any references to the FDA from the trial would risk creating a misleading, incomplete, and confusing picture for the jury.

Id.  “[I]f the evidence was half-baked, containing some references to the FDA but not explaining what role the FDA played with respect to the [IVC] filters, the jury would be left to speculate about the FDA’s involvement and conclusions.”  Id.

Until IVC Filters, we had feared that a single mass tort, under a discretionary standard of review and with the unwillingness of appellate courts to require MDL do-overs, could tilt the evidentiary playing field towards what IVC Filters cogently described as “a misleading, incomplete, and confusing picture for the jury” that excluded §510k clearance evidence that previously been admissible almost as a matter of course.  Now our side has a clearly articulated and compelling opposing view to argue.

Today’s post is another guest post from Kevin Hara, of Reed Smith, who is on his way to becoming a semi-regular blog contributor.  This post is about forum non conveniens, which is more discretionary, and less enforceable than personal jurisdiction as a limitation on plaintiff-side (or even defense-side) forum shopping, but which, as Kevin’s post demonstrates, is still better than nothing.  As always with our guest posts, the author deserves 100% of the credit, and any blame, for what follows.


As a child of the 80s (slight pause for the chuckling and/or groaning here), there are so many images that flash through one’s mind as we reflect, fondly, for the most part, on that decade in discussing an Illinois appellate court’s decision in McIver, et al., v. American Medical Systems, Inc., et al., 2017 IL App (5th) 170011-U, 2017 WL 6327143 (Ill. App. Dec. 8, 2017), sending litigation tourists on an about-face based on the doctrine of forum non conveniens.  Though spelled differently, this McIver case makes us recall another MacGyver, the hit 80s television show (which, incidentally, my wife and I enjoy watching together in reruns.)  However, before delving into MacGyver/McIver, it is impossible to not to discuss some pop culture references from that era, even though we could not explore even the tip of the 80s iceberg: but there was the music – from pop, Michael Jackson, Madonna, Prince, to rock bands known for ballads, a la Journey, Bon Jovi, Van Halen, Duran Duran and too many others to name, including the hair bands, the rise of rap music, heavy metal, and a bevy of one-hit wonders.  There was the fashion – perhaps stretching that word a bit – legwarmers, parachute pants, camouflage, perms, bangles, hairspray, and shoulder pads!  Who can forget the movies? Back to the Future, the Indiana Jones trilogy (not including Crystal Skull which came much later, apologies Shia Labeouf), ET, The Shining, Empire Strikes Back, Return of the Jedi, Wall Street, The Color Purple, Beverly Hills Cop, Karate Kid, Sly, Arnie, Bruce Willis, all things explosions and action! and far more.  The events.  Lakers v. Celtics.  Air Jordan. The tragic Challenger explosion.  Chernobyl.  Mount Saint Helens (not all the explosions were in the movies, unfortunately).  Macintosh Computers.  Windows.  The fall of the Berlin Wall.  Perestroika.  Prozac.  CDs.  The Oprah Winfrey Show.  Rubik’s Cube.  All of the above, and so much more.

Before we disappear down a virtual “Who Framed Roger Rabbit?” hole, let’s revisit the classic 80s television series, “MacGyver,” starring Richard Dean Anderson that is apropos to our discussion today.  MacGyver was iconic for numerous reasons, with Anderson as the title character, a secret agent for the fictional Department of External Services, physicist, special forces veteran, and problem solver extraordinaire.  Although MacGyver undoubtedly qualifies as campy, far-fetched, and perhaps melodramatic, it was also imaginative, witty, clever, fun, and at times, touching.  MacGyver famously extricated himself –  and the world – from the brink of doom on countless occasions using ordinary objects, often including his ever-trusty Swiss Army knife (rather than, say, a sonic screwdriver), to perform extraordinary feats.  For instance, MacGyver is now officially defined in the Oxford English Dictionary, as a verb meaning “Make or repair (an object) in an improvised or inventive way, making use of whatever items are at hand.”  See, perhaps the most notable real-world example, here.  Some of MacGyver’s most amazing inventions or accomplishments included using candlesticks, a rubber mat, and an electrical cord to improvise a defibrillator; smashing a pair of binoculars, removing a prism, and deflecting a laser beam back to the emitter, destroying it; plugging a sulfuric acid leak with chocolate, containing sugars which react with acid to form elemental carbon, and a gummy residue (tested successfully by mythbusters); and using jumper cables with coins in the teeth, wiring them to a generator, an creating an arc welder (which, incidentally also proved to be functional.)

But not even MacGyver, despite his quick thinking and unparalleled toolbox, could “MacGyver” jurisdiction over the defendant in the McIver case for the Maryland resident plaintiffs.  McIver was yet another multi-plaintiff complaint filed in 2012 in Illinois state court, involving 75 plaintiffs from 23 states, (only one from Illinois), joined in a single action, alleging product liability claims in connection with prescription pelvic mesh products manufactured by AMS.  Id. at *1.  As with most other multi-plaintiff complaints, the only connection among plaintiffs is that they all received pelvic mesh implants.  The defendant filed a motion to sever the claims of the non-resident plaintiffs, arguing misjoinder, and concurrently filed a motion to dismiss for wrongful venue.  Id.  The parties agreed that the defendant would answer or respond to the complaint after resolution of the motions, as ordered by the court.  In March 2013, the trial court denied defendant’s motion to sever, apparently reasoning that venue was proper based solely on the presence of one Illinois plaintiff, with the order stating “that AMS would have to defend a case in St. Clair County regardless of whether the motion to sever were granted.”  Id.  Shades of the reversed California Supreme Court BMS decision.  The plaintiffs prepared the order, which significantly failed to provide a deadline for the defendant to answer or respond to the complaint, nor did the court order such an answer.  As an aside, given what we know of St. Clair County, it comes as no surprise that the trial court denied the motions to sever or dismiss.  As indicated, had plaintiffs filed McIver this year, the defendant very well could have moved to dismiss for lack of jurisdiction under BMS.

Time passed, and 73 of the 75 plaintiffs settled with the defendant, leaving only Paula and Earl Conway of Essex, Maryland.  Id. at *2.  After the court set the case for trial, the defendant, now faced with only nonresident plaintiffs, filed a motion to dismiss based on forum non conveniens (this was still pre-BMS), arguing that “’the public and private interest factors relevant to the consideration of its motion strongly favored dismissing [plaintiffs’ action]’” such that it could be refiled in Maryland.  Id.  The overwhelming majority of relevant events, including plaintiff’s mesh implant, her treating physicians, and medical records were located in Baltimore, and fact witnesses including friends, family, and coworkers “would be expected to live in or around Baltimore County.”  Id.  After receiving answers to interrogatories confirming that plaintiffs’ fact witnesses all resided outside the state of Illinois, the defendant supplemented its motion, asserting that plaintiffs’ case had “absolutely no connection” to Illinois.  Id. at *3.

It being St. Clair County, the defense lost again, as the trial court denied the motion without explanation.  Id.

On appeal, the defendant argued that the trial court abused its discretion in denying the forum non motion (with which we wholeheartedly agree), and plaintiffs claimed that the motion was untimely under Illinois Supreme Court Rule 187(a).  That rule mandates that any forum non conveniens (“FNC”) motion must be filed not later than 90 days after the last day that a party may file its answer.  Id.  The appellate court noted that the trial court ordered the parties to meet and confer, but did not order the defendant to file an answer and, since no answer was filed, the FNC motion was timely under Rule 187(a)’s “unambiguous” deadline. Id.

Strike one.

Plaintiffs claimed defense-side “gamesmanship” despite their own drafting the scheduling order at issue, claiming that the defendants should have filed the FNC motion at the “earliest opportunity.”  Id. at *4.  Again, the appellate court disagreed, finding that the defendant brought the motion with “reasonable and appropriate promptness,” noting that the parties had tentatively agreed to the filing deadline for AMS’s answer, but “[a]t no point did the plaintiffs seek an order requiring” the defendant to answer by a specific date.  Id.

Strike two.

Ultimately, the court went further, and stated that “even assuming that [the defendant] had filed an answer in 2013,” it would still conclude that the 2016 forum non conveniens motion was timely.  Id.  The court’s reasoning was simple – the case started with 75 plaintiffs from 23 states, and only after all but the two Maryland plaintiffs were dismissed, could the defendant have “had a clear and valid basis for seeking” transfer to that forum.  Id. at *5.

Strike three.

Additionally, the appellate court found no prejudice to the plaintiffs, despite their case being pending more than four years when the defendant filed motion.  Plaintiffs provided no discovery during all that time, and only later – more than four years after filing – did plaintiffs’ initial discovery responses confirm that plaintiffs’ witnesses resided predominantly in Maryland.  Id.

Nor was the court sympathetic to plaintiffs’ claim that transfer would cause delay.  Plaintiffs’ own fault, the court found, because any plaintiff filing in a foreign jurisdiction (litigation tourists) and combining his/her claims with other claimants in one action takes a “calculated risk” that those choices might result in dismissal or delay.  Id.  The court put it bluntly: “[t]o the extent that the present case languished in the circuit court, it did so without objection and with the plaintiffs’ implicit consent.”  Id. (emphasis added)

Finally, reaching the merits of the FNC issue, the court considered both the private and public interest factors, along with plaintiffs’ choice of forum, which was “much less reasonable,” because the vast majority of relevant events occurred outside of St. Clair County.  Id. at *7.  Neither the defendant nor the plaintiffs were Illinois residents, and the convenience of the parties was neutral.  Id.  However, access to evidence “strongly favor[ed] a transfer” to Maryland, given the location of most of the witnesses in that state.  Id.  Likewise, compulsory process would be impossible in Illinois, and the costs of securing witnesses overwhelmingly supported transfer.  Id.  Finding that the practical applications of the trial were a nonfactor, the court turned to the public interest factors, concentrating on which state, Illinois or Maryland, had a greater interest in the litigation.  Id. at *8.  The fact that the plaintiff’s mesh implant surgery occurred in Maryland, combined with the unfairness of imposing jury duty on Illinois residents, favored transfer to avoid burdening its taxpayers with a matter “otherwise unrelated to their state.”  Id. In sum, the appellate court ruled that the trial court erred in denying the forum non conveniens motion because Illinois had “no relevant or significant factual connections to the case.”  Id. at *9.

Thankfully, the appellate court considered the facts – in conjunction with some common sense – and the applicable law, and reversed and remanded with instructions to dismiss the case.  Even though this decision is non-precedential, it puts some handwriting on the wall.  Litigation Tourists Go Home, even from St. Clair County.  And if not FNC, personal jurisdiction under BMS is waiting in the wings.  Not even MacGyver, with his remarkable ingenuity, endless amounts of duct tape, Swiss Army knives, and any assortment of household items, could craft a way back into Illinois state court for these litigation tourist plaintiffs.

Summary judgment isn’t normally available for credibility issues.  During the “summary judgment trilogy” of 1986, the Supreme Court stated, “[c]redibility determinations, the weighing of the evidence, and the drawing of legitimate inferences from the facts are jury functions, not those of a judge . . . ruling on a motion for summary judgment.”  Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986).  Or, more recently, “[a] district court generally cannot grant summary judgment based on its assessment of the credibility of the evidence presented.”  Schlup v. Delo, 513 U.S. 298, 332 (1995).  But every rule has its exceptions for extreme circumstances.

The key word from Schlup is “generally,” and in today’s case, Gill v. Teva Respiratory, LLC, 2017 WL 6614228 (D. Conn. Dec. 27, 2017), the plaintiff’s own testimony was simply too unbelievable and contrary to all other evidence (and common sense) to defeat summary judgment.  The plaintiff claimed to have inhaled a thumb tack – that’s right, a thumb tack – from the defendant’s allegedly sealed medical device (an inhaler).  She sued both the maker of the inhaler and the intermediate seller (a pharmacy).  Both received summary judgment.

There were a lot of problems with her story.  For one thing, after she inhaled the thumb tack, she didn’t seek medical attention for “several days,” despite the problem being serious enough to require surgery.  Id. at *1.  But that wasn’t even the basis for the ruling.

  • Plaintiff claimed that she put the product in her car’s “glove compartment” for about a “week” before ever using it, leaving it in its original packaging.  Id. at *1.
  • The manufacturer produced extensive “evidence about its manufacturing and inspection process to preclude any inference that it could have allowed the thumbtack to enter the inhaler.”  Id.; see also id. at *2 (further describing process).
  • Plaintiff’s medical records refuted her testimony, indicating that she had kept the product “in her purse” and “not [in] her glove compartment.”  Id. at *1.
  • While in her purse, the product’s “cap had fallen off,” and “her children had put the thumbtack inside the inhaler.”  Id.
  • While plaintiff claimed she had used the product only once, the product’s “mechanical counter” indicated that it had been used 34 times.  Id. at *2.

In response, plaintiff did nothing. She “did not conduct any discovery.”  She “neither disputed defendants’ evidence” nor submitted any opposing “statement of material facts” as the rules required.  Id.  Plaintiff’s lassitude resulted in the defendant’s factual statement being “deem[ed]” “true.”  Id.  Most importantly, plaintiff “had no explanation for the[] statements as reported in her medical records.” Id. at *2.

Thus, the facts about manufacturer’s quality control systems were deemed true, the plaintiff’s testimony was refuted by her own medical records, and plaintiff offered no explanation for anything. “It is not simply that plaintiff has failed to rebut defendants’ evidence” about its quality control; it was the weakness of plaintiff’s own testimony.  Id. at *3.

This situation was sufficiently extreme to support entry of summary judgment on the basis of the plaintiff’s testimony offered in support of an injury from an alleged defect in the device being incredible and unworthy of belief.

[I]n rare circumstances a court must necessarily undertake some evaluation of a plaintiff’s credibility at the summary judgment stage. . . .  [W]here the plaintiff relies almost exclusively on his own testimony, much of which is contradictory and incomplete, it will be impossible for a district court to determine whether the jury could reasonably find for the plaintiff, and thus whether there are any “genuine” issues of material fact, without making some assessment of the plaintiff’s account.

Id. at *2 (quoting Rojas v. Roman Catholic Dioceses, 660 F.3d 98, 105 (2d Cir. 2011)).  “[T]here may be certain extraordinary cases, where ‘the facts alleged are so contradictory that doubt is cast upon their plausibility, [for which] the court may pierce the veil of the complaint’s factual allegations and dismiss the claim.” Id. (quoting Jeffreys v. City of New York, 426 F.3d 549, 555 (2d Cir. 2005)).

Those “rare circumstances” were present in Gill:

[P]laintiff’s own account of the facts − which is the only evidence relied on by plaintiff to sustain her claim − is rife with irreconcilable contradiction.  Plaintiff has no explanation for the multiple medical notes . . . reflecting that the inhaler was in her purse with the cap off and accessible to her children, rather than in its original packaging in her glove compartment as plaintiff claimed.  Nor does plaintiff have any explanation for why the inhaler’s dosage count reflected its prior use 34 times, rather than her initial use of a new inhaler as plaintiff self-servingly claimed.

Id. at *3.  Summary judgment was therefore appropriate, since “the manifest contradictions and discrepancies in plaintiff’s own account, no reasonable jury could conclude that the thumbtack entered the inhaler at any time that the inhaler was in the possession or control of either one of the defendants.”  Id.

The alternative – letting juries decide every “credibility” dispute, no matter how far-fetched of fanciful the plaintiff’s testimony might be – was not sound jurisprudence. To “require district courts to allow parties to defeat summary judgment simply by testifying to the allegations in their pleadings would license the mendacious to seek windfalls in the litigation lottery.” Id.

Having seen far too many “mendacious” plaintiffs obtain “windfalls” in “litigation lottery” settlements, we could not agree more.

This week saw the birthdays of two folks who were sort of prominent in our youth.  First, Uri Geller, the Israeli ‘psychic’, turned 71.  He showed up on our tv constantly in the 1970s and 80s, bending spoons with his mind.  Was this guy on the level? Can you read our mind and discern our opinion on that score?  A court once ordered Geller to refund an audience member’s money and pay costs, finding that Geller’s feats of telepathy … weren’t.   Also this week, the great film director George Roy Hill would have reached the ripe old age of 96, had he not inconveniently passed away in 2002.  We remember Hill fondly for a pair of movies he directed that starred Paul Newman and Robert Redford:  Butch Cassidy and the Sundance Kid (1969) and The Sting (1973).  The latter ruled the Academy Awards its year, receiving ten nominations and winning seven, including Best Picture, as well as a Best Director nod for Hill.  Besides boasting a stellar cast (Robert Shaw played the villain), The Sting was blessed with intricate plotting – how to con a crook out of his money without his even knowing he had been conned – and a bouncy (though somewhat anachronistic) ragtime score by Marvin Hamlisch.  With all its virtues, The Sting did feel a bit overlong, which led to our single favorite all time film critic witticism: “Oh Sting, where is thy death?”

For some reason, today we have scams on our mind.

And thus we turn to the case of Eastman v. Biomet, Inc., 2017 WL 5257130 (N.D. Ind. Nov. 9, 2017).  The plaintiff had alleged injuries from a metal-on-metal hip implant.  He entered into a master settlement agreement that provided a procedure for categorizing case values.  He signed a release and received $25,000, which the release said constituted full payment.   End of story, right?  Well, as in The Sting, we have a false ending.  For the plaintiff made a few modifications in the release he signed.  These were just little stylistic flourishes, mind you, such as changing “binding” to “nonbinding,” “irrevocable” to “revocable,” and moving the governing law from Indiana to Arkansas.  Having improved the release in those minor ways, the plaintiff deposited the check, waited a decent interval, and then filed another lawsuit versus the defendant, seeking the difference between the $25,000 and what he thought he should have received in settlement.

This subsequent lawsuit was filed pro se, so at least we can say that no lawyer played a role in rigging this unpleasant exercise.  Both (!) parties moved for summary judgment.  And because the world is round(ash), gravity makes things fall down, the Patriots (sigh – what’s today’s theme again?) are once again headed for the Super Bowl, and the Judge was a sentient being, the defendant won and the plaintiff lost.  One cannot settle a case and eat it too.  Or something like that.  The court was plainly irked with the plaintiff for “secretly modifying” the release and changing three words “surreptitiously.”  We do not know the details as to how the paperwork was handled, so it is hard to see how the changes were secret.  Wasn’t the signed release sent to someone?  Be that as it may, there is something undeniably improper about pocketing settlement money and then filing another lawsuit on the same claim.

The Eastman plaintiff claimed that he had merely “conditionally signed” the release.  He agreed in principle with the defendant that he should receive some money.  So far so good. The remaining dispute was confined to the trivial issue of how much.  Under this rationale, settlements are astonishingly easy.  It’s a wonder that our courts are clogged with so many unsettled cases. Perhaps this clever plaintiff has discovered a way to thin out the civil dockets.

Here, the plaintiff had a beef with the defendant over the categorization of his injury.  The defense reduced the plaintiff’s award based upon evidence of an alternative cause for the implant failure. The plaintiff disagreed with said reduction.  What to do about such a disagreement?  The folks who drafted the master settlement agreement were sufficiently farsighted to provide for a mediation process for resolving such disputes.  But rather than avail himself of that mediation process, the plaintiff simply changed a few words in the release and took the money.  That, it turns out, is not quite kosher.  One cannot seize the benefits of a settlement whilst rejecting the annoying bits. The defendant never agreed to any of the plaintiff’s editorial innovations.  Clearly, no defendant would enter into the one-way ratchet sort of deal that the plaintiff favored.  The plaintiff had the choice to enter into the settlement and mediate, or proceed to trial on the merits.  His preferred hybrid of take-some-money-and-still-litigate was not on offer.

If there is one thing we have learned over our years in litigation, it is this: courts like settlements.  Twice in our career we have won motions to enforce settlements.  We have never lost such a motion, nor ever heard of anyone else losing such a motion.  The Eastman plaintiff’s maneuvers posed a threat to the settlement process in that case, and, for that matter, that entire form of settlement in other cases.  Consequently, it is unsurprising that he lost.  The court granted summary judgment in favor of the defendant.  The plaintiff’s maneuvers also were an insult to fair-dealing – period.  Movies are one thing, but in real life, we root against an attempted sting.

This guest post is by Kevin Hara, an associate at Reed Smith and relatively frequent contributor to the Blog.  Here, he discusses two recent favorable procedural developments in further appeals from two really awful decisions by intermediate courts of appeals.  As always, our guest posters are 100% responsible for what they write – due 100% of the credit, as well as any blame.  Take it away Kevin.


SCOTUS Calls For Solicitor General’s Views In Third Circuit Fosamax Case

Friday December 8 was a day with two items that are particularly noteworthy because of their potentially momentous implications. Remember the Blog’s previous lambasting of the Third Circuit’s unprecedented Fosamax preemption decision and the haymaker that court unleashed on the drug and device industry, in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017)?  Now, there is positive news to report. The Supreme Court has invited the Solicitor General “to file a brief in this case expressing the views of the United States.” Merck, Sharp & Dohme Corp. v. Albrecht, et al., No. 14-1900 (Order, Dec. 8, 2017).

What is that? Here is SCOTUSBlog’s description:

“CVSG” stands for “call for the views of the Solicitor General.”  In most cases in which someone is seeking review of the lower courts’ decision, the Court will issue a straightforward grant or denial.  But sometimes the Court will want the government’s views on what it should do in a case in which the government isn’t a party but may still have an interest — for example, because the interpretation of a federal statute is involved.  So the Court will issue an order in which it “invites the Solicitor General to file a brief expressing the views of the United States.”  It isn’t an “invitation” in the sense that the federal government gets to decide whether it wants to file a brief at all, because the Court expects the government to file.  There is no deadline by which the government is required to file the brief, however.  And the government’s recommendation, although not dispositive, will carry significant weight with the Court.

In Fosamax, this development is important because it signals that the case stands out from the general certiorari pool, meaning that review is more likely to be granted.  Statistics are surprisingly hard to come by, but a law review article, Thompson & Wachtell, “An Empirical Analysis of Supreme Court Certiorari Petition Procedures:  The Call for Response and the Call for the Views of the Solicitor General,” 16:2 G. Mason L.R. 237 (2009), analyzed ten years of Supreme Court cases (1994-2004) and concluded:

The overall grant rate increases from 0.9% to 34% following a CVSG from the Court; in other words, the Court is 37 times more likely to grant a petition following a CVSG.  For petitions on the paid docket, the grant rate increases even more, to 42%; a paid petition is 47 times more likely to be granted following a CVSG.

Id. at 245 (emphasis added).  If those somewhat dated statistics are even close to currently accurate, the Fosamax CVSG is a big deal.

Recall that the Third Circuit grossly misinterpreted the “clear evidence” preemption test from Wyeth v. Levine, which held that without clear evidence that the FDA would not have approved the label change, a court cannot rule a manufacturer’s compliance with federal and state law is impossible, and thereby preempted, already an exacting defense.  As the Blog explained in praising the petition for certiorari, the Third Circuit distorted Levine, applied an unprecedented standard, and ruled that a manufacturer could not invoke preemption without “clear and convincing” evidence that the FDA would have rejected a proposed warning.  Thus, not only did the Third Circuit reverse summary judgment for the manufacturer in more than 1000 cases, it rendered impossibility preemption even more difficult than the anti-preemption justices in Levine intended.  The Blog also discussed the Product Liability Advisory Council’s amicus brief in support of the petition here, which explained that the Third Circuit’s decision invites further lower court confusion, obliterates the district court’s ruling that was supported by undisputed evidence, encourages pharmaceutical manufacturers to flood the FDA with proposed label changes, and threatens to stifle the innovation necessary to develop new, potentially life-saving drugs.

This latest development raises defense hopes that SCOTUS will grant the petition, and finally reverse one of the worst decisions of 2017, which would be a huge win for the manufacturer in particular, and of greater significance for the big picture for pharmaceutical companies and consumers in general. Stay tuned.

New Jersey Supreme Court Grants Review of Accutane Cases

Also on December 8, the New Jersey Supreme Court granted the appeals in all of the Accutane cases that the appellate court revived back in July. The Blog has monitored the Accutane litigation through many of the twists and turns of its tortuous existence for more than a decade, first with the Accutane MDL, and then with the New Jersey cases.  As a resident of the San Francisco Bay Area, when I think of the Accutane litigation, I automatically picture Lombard Street, often touted “The Crookedest Street In The World,” with its eight hairpin turns and switchbacks that span the 600 feet of the street’s natural 27° grade.  In fact, Lombard Street is not even the most crooked street in San Francisco, because Vermont Street, has a greater sinuosity at 1.56 versus 1.2 for Lombard, though Vermont at seven turns, has one fewer than its more famous cousin.   Lombard Street and its adornment of brick red and beautiful flowers attracts thousands of tourists per year.  This meandering avenue is difficult to traverse, requires careful navigation, has been around a long time, and produced extreme frustration for those who occupy it: if it sounds familiar, bear in mind that the Accutane litigation likewise has a lengthy history, ongoing since 2003, has zigged and zagged, and neither side is particularly thrilled with the results.  The Blog has discussed many of the good aspects here, (vacating plaintiff verdicts) here, (dismissals based on learned intermediary doctrine) here, (MSJ granted) and here (warnings adequate as a matter of law), as well as the very bad Appellate Division decisions earlier this summer, when the court reinstated more than 2000 causation based dismissals.

With that in mind, here is a very brief summary of the mind-bending history of the Accutane saga and the battle over the proper expert testimony that has hopefully neared its dénouement.  As already discussed at length, the Appellate Division reversed the trial court’s decision that excluded plaintiffs’ expert causation testimony, reviving more than 2000 lawsuits.  Not surprisingly, the manufacturer appealed, supported by amicus briefs from 21 of New Jersey’s largest employers, including many Roche competitors, the HealthCare Institute of New Jersey, the New Jersey Chamber of Commerce, the American Medical Association, and eight scholars and professors of law.  When it comes to expert testimony, New Jersey unfortunately travels The Road Not Taken, applying a “relaxed” standard of expert testimony in toxic tort cases, as set forth in Rubanick v. Witco Chemical Corp., 125 N.J. 421 (1991), rather than the more rigorous federal Daubert standard.  Under Rubanick, expert testimony may be admitted “even though it is controversial and its acceptance is not widespread,” only if “it is based on a sound methodology that draws on scientific studies reasonably relied on in the scientific community and has actually been used and applied by responsible experts or practitioners in the particular field.”  Id. at 447.  In Kemp v. State, 174 N.J. 412, 425-426 (2002), the court ruled that the inquiry was not based on reasonableness, but instead examines “whether comparable experts in the field [would] actually rely on that information.  Kemp, 174 N.J. at 426 (citations and quotations omitted).  Since Rubanick and Kemp, New Jersey courts have continued the state’s unique application of scientific expert testimony with an approach distinct from the more exacting federal standard, resulting in inconsistency, confusion, and the morass of the Accutane litigation.

As the Blog discussed, and the amici explained, the Accutane trial judge applied a standard similar to Daubert, but the Appellate Division reversed the decision based on Rubanick. In so doing, the appellate court essentially ignored the gold standard of scientific evidence, epidemiological studies all but one which failed to “demonstrate[] a statistically significant increased risk of developing Crohn’s disease.”  In re Accutane Litigation, 451 N.J. Super. 153, 168  (App. Div. July 28, 2017).  Nonetheless, the Appellate Division allowed the plaintiffs’ experts to rely on evidence that should have been excluded as unreliable, such as animal studies, anecdotal case reports, and analogous medicines – in other words, scientifically unsound data.  Id. at 165-166.  Similarly to the Fosamax decision, this represents not only bad law and bad precedent, but also has far-reaching implications.  Pharmaceutical manufacturers and health professionals resoundingly decried the Accutane decision as one that will stifle research and development, and the practice of medicine out of the uncertainty of scientific evidence, and fear of legal reprisals.  The amici implored the New Jersey Supreme Court to adopt Daubert’s methodology to reaffirm the trial court’s role as a gatekeeper to ensure that only reliable scientific evidence informs the jury’s decision.  Again, the industry can take heart in the court’s order granting review of the Appellate Division’s abysmal decision, and hope that the New Jersey Supreme Court will allow modern scientific principles, rather than the unreliable and questionable methods, to govern expert testimony.  If that occurs, no doubt will the New Jersey high court reinstate the trial court’s ruling, and order dismissal of the more than 2000 cases for lack of  causation evidence.

Just two days ago, Bexis lowered the boom on the Third Circuit’s recent decision in Cottrell v. Alcon Labs, ___ F.3d ___, 2017 WL 4657402 (3d Cir. Oct. 18, 2017).   In a 2-1 decision, the Cottrell court permitted the plaintiffs to proceed on the notion that making eye drop drips bigger than they have to be is a consumer protection violation.  To Bexis’s eyes, that decision was blind to the lack of standing, the absence of any “substantial economic injury,”  and the FDA’s non-approval of eye drop drips of the “smaller” size plaintiffs claim it is somehow illegal not to make under state law.  It turns out that there is someone else out there even more unhappy with the Cottrell decision than Bexis: the defendant.  Now we have the defendant’s Petition for Rehearing and Rehearing En Banc,  https://www.druganddevicelawblog.com/wp-content/uploads/sites/30/2017/11/Cottrell-rehearing-petition.pdf which makes an insightful and compelling case for undoing the panel’s decision.


Two preliminary matters are worthy of comment before we tell you what the Petition said. First, we have been so unkind about the Third Circuit’s error in the Fosamax case that we managed to attract the attention of the excellent CA3 blog.   In that blog, the author wondered whether our dissection of Fosamax was perhaps a bit more violent than necessary.  The author also wondered whether we were coming close to accusing the court of bad faith.  Yes to the former, but definitely No to the latter.  As we told the CA3 blog, we took issue with what we saw as bad reasoning, but never-ever thought there was any bad faith.  (The CA3 blog was generous enough to print our disclaimer.  Thanks for that.)  By and large, we are mighty proud of our home circuit.  We know several of the judges, and every one of them is honorable, hard-working, and much smarter than we are.  Sometimes we are not going to agree with the court’s decisions.  Luckily for us we work in a profession and live in a country where debate and criticism are allowed.  Second, succeeding on a petition for rehearing and rehearing en banc is not easy.  When we clerked for Ninth Circuit Judge William Norris, it seemed there was a presumption against such petitions.  Who wants to admit they were wrong?  And yet we remember one time our judge was on a panel where things strayed from the norm.  Another member of the panel (who will remain unnamed) loved to decide cases before oral argument and draft a memorandum disposition rather than a bench memorandum.  This judge prided himself on having almost no backlog.  He pushed for deciding a particular contract dispute via a mere memorandum disposition, not a published opinion, because he saw the issues as being too obvious and insignificant for the Federal Reporter.  And so a memo dispo issued.  But then the losing party filed a petition for rehearing that was not only insistent, but it made a lot of sense.  We met with our Judge in his chambers to talk it over.  The telephone rang.  It was the third member of the panel, who began by saying, “Bill, I think maybe we got one wrong.”  The two judges confabbed, and then set about persuading the third to change his mind and change the outcome.  It took some arm-twisting, but in the end, justice was done.  A mistake led to a proud moment.  By the way, the Ninth Circuit Judge who called our Judge was Anthony Kennedy.  He is now on the U.S. Supreme Court.  So whenever we hear criticisms of Justice Kennedy for fence-sitting, or for grounding some of his opinions in “the right to define one’s own concept of existence, of meaning, of the universe, and of the mystery of human life” or, much worse, international law, we recall his extraordinary integrity and modesty, and how he was supremely interested in getting things right.


Back to the Cottrell Petition. The main points in favor of revisiting the Third Circuit’s decision are that it is contrary to Finkelman v. National Football League, 810 F.3d 187 (3d Cir. 2016), it “radically expands Article III standing,” and that it directly conflicts with Eike v. Allergan, Inc., 850 F.3d 315 (7th Cir. 2017).  Moreover, the plaintiff’s inherently speculative theory of injury in fact was rejected by federal courts in Massachusetts and Missouri.  (When a court comes out with a more pro-plaintiffy position than courts in Massachusetts and Missouri, that’s really saying something.)  That theory was also rejected by the district court in Cottrell.  And then the Third Circuit reversed that rejection.  


Remember that the Cottrell plaintiffs did not claim that the medications caused them physical harm or were ineffective in treating their eye conditions, or that the defendants misrepresented or omitted any information about the medications or the number of doses expected.  Rather, the plaintiffs simply insist that smaller eye drops would have cost them less.  How is that any different from the Third Circuit’s earlier, controlling Finkelman case, where the plaintiffs had purchased two Super Bowl tickets on the resale market for $2,000 each, and contended that the National Football League had violated New Jersey’s ticket law by not offering at least 95% of tickets to the general public and instead withholding most tickets for league insiders?  The plaintiff in Finkelman alleged that the NFL’s conduct had caused him injury by reducing the supply of tickets, thereby driving up the cost of tickets on the resale market.  The Third Circuit in Finkelman held that the plaintiff lacked standing because the injury was wholly speculative.  Sure, maybe the NFL’s withholding of tickets increased prices on the resale market, but “it might also be the case that it had no effect on the resale market,” and indeed tickets might even have been more expensive in plaintiff’s hypothetical resale market, as members of the general public may have greater incentives than league insiders to resell at high prices.  (We have to admit that, as residents of Philadelphia, where the local team has the best record in the entire NFL, the availability of Super Bowl tickets is a much, much bigger issue to us right now than the size of eye drops.)

The Petition makes the point that, just as in Finkelman, other market effects might have produced a result very different from what the plaintiffs theorized.  In Cottrell, the plaintiffs essentially presumed that the defendants price their products solely according to volume, such that “changing the eyedropper size would not change the price of the medicine, while extending the useful lifespan of each bottle, driving down [the plaintiffs’] aggregate costs.” But it is just as likely that use of smaller drops would prompt use of different sized containers, or that smaller drops would result in a higher price – because of more doses – for the same container.  Who knows?  All we do know is that the allegations of the complaint do not “affirmatively and plausibly” add up to an “injury” caused by the defendant’s conduct.  

The Petition nicely captures the absurdity of the Third Circuit’s analysis, under which consumers suffer Article III injury from “unfairness” whenever they “walk into a supermarket and buy a product — from toothpaste, to ketchup, to deodorant, to hairspray — so long as they can then conceive of a way that the product might be dispensed more efficiently.”  The Petition also nicely exposes the weakness in the Third Circuit’s effort to distinguish away the Seventh Circuit decision in Eike.  According to the Cottrell majority, Eike “seemed to begin its standing analysis with a determination that the plaintiffs had ‘no cause of action.’” But while it is true that the Seventh Circuit did (correctly) conclude that the plaintiffs had “no cause of action,” the Seventh Circuit also separately held that there was no Article III injury, without ever suggesting a causal connection between the two.  Eike, 850 F.3d at 318.  The Seventh Circuit got it fundamentally right when it held that the fact that a seller does not sell the product that you want, or at the price you’d like to pay, is not an actionable injury; “it is just a regret or disappointment.” 

As residents in, and fans of, the Third Circuit, the Cottrell decision certainly is cause for “regret and disappointment.” We called this post a “second look” at the eye-drop litigation.  It is the second look we have taken at the Cottrell case.  We hope that the Third Circuit takes a second look.      



Last month we brought you word of an excellent result (preemption) in a ridiculous case − a class action claiming that the drops in eye-drops are too big.  That decision was in accord with an earlier decision likewise dismissing such claims on preemption grounds. See Thompson v. Allergan USA, Inc., 993 F. Supp.2d 1007 (E.D. Mo. 2014) (discussed here).

However, there is another ground on which these bottom-feeding actions have been dismissed – lack of sufficient injury to support standing.  After all, the concept of some sort of ideal “price” for a product, above which it is improper to charge is a will-o-wisp, apparently knowable only to plaintiff-side experts (just ask them, they’ll tell you).  This is called “benefit of the bargain” by such experts.  Courts tend to use a different description – “absurd.”

[Plaintiff] received the drug she was prescribed, the drug did the job it was meant to do . . ., and it caused no apparent physical injuries. Under such circumstances, there could be no ascertainable loss. . . .  The Court believes Plaintiffs’ proposed liability theory, which requires no demonstrable loss of any benefit, would lead to absurd results and holds that Plaintiffs fail to state a claim as a matter of law.

In re Avandia Marketing Sales Practices & Products Liability Litigation, 639 F. Appx. 866, 869 (3d Cir. 2016) (citations and quotation marks omitted), affirming, 100 F.Supp.3d 441, 446 (E.D. Pa. 2015), also holding  “absurdity is inherent in the nature of Plaintiff’s claimed loss” because it was “based only on the idea that [the product] is inherently worth some unspecified amount less than whatever Plaintiff might have paid for it”).

That was essentially how the Seventh Circuit reacted to these same eye drop allegations in Eike v. Allergan, Inc., 850 F.3d 315 (7th Cir. 2017) (discussed here).  We described the absurd theory that the plaintiffs were pursuing in our Eike post, and because we’re lazy, we’ll simply repeat that here:

The plaintiffs sued pharmaceutical manufacturers of eye drops used for the treatment of glaucoma because the drops were bigger than they needed to be.  The theory is that the plaintiffs were paying more than they would have if the drops were smaller.  The plaintiffs alleged no conspiracy among the defendants.  This was not an antitrust case. . . .  Nor did the plaintiffs allege any misrepresentations.  Rather, the plaintiffs simply sought, because they thought it would be less expensive, a smaller dose product that nobody made.

The Seventh Circuit essentially agreed: “The fact that a seller does not sell the product that you want, or at the price you’d like to pay, is not an actionable injury; it is just a regret or disappointment − which is all we have here, the class having failed to allege ‘an invasion of a legally protected interest.’”  850 F.3d at 318 (citations omitted).  Accord Carter v. Alcon Laboratories, Inc., 2014 WL 989002, at *4-5 (E.D. Mo. March 13, 2014) (also dismissing identical claim for lack of any cognizable injury).

Apparently, however, the inherent triviality of that claim is no deterrent to today’s class action lawyers, who seem to have nothing better to do than measure the comparative value of eye drop drips.  After several attempts, they seem to have found a couple of judges credulous enough to allow one of these non-injury cases to survive – at least on the standing/injury issue.  That’s today’s case, Cottrell v. Alcon Labs, ___ F.3d ___, 2017 WL 4657402 (3d Cir. Oct. 18, 2017).   Looking to the “scientific consensus on eye drop size,” the majority is willing to let plaintiffs proceed on the notion that making eye drop drips bigger than they have to be is a consumer protection violation.  Id. at *2.  They may proceed even though “no defendant has reduced their products’ drop sizes,” and thus there is no competing product, priced at any price, against which to ascertain the plaintiffs’ purportedly “substantial economic injury.”  Id.  Nor does it appear that the FDA has ever approved – or even had submitted to it – eye drop drips of the “smaller” size plaintiffs claim it is somehow illegal not to make under state law.

The standing question focused on “injury in fact,” and as the party bringing the claim, plaintiffs had the burden of proving standing.  Id. at *4.  To find standing here, the majority (conceding that the district court’s no-standing analysis had “some persuasive appeal”) went deep into the weeds – breaking “injury in fact” into various “components.”  Id. at *5.  The first was a “legally protected interest.”  Conveniently, this allowed the Cottrell majority to base their result on something that prior precedent had “not defined” or even “clarified whether [it] does any independent work in the standing analysis.”  Id.  Presto!  A clean slate on which to build a standing castle in the air.  “[W]hether a plaintiff has alleged an invasion of a ‘legally protected interest’ does not hinge on whether the conduct alleged to violate a statute does, as a matter of law, violate the statute.” Id.  Impressive – this is a holding that the merits don’t matter. We’ll come back to that.

The second aspect of Cottrell’s drawing on a clean slate is “that financial or economic interests are ‘legally protected interests’ for purposes of the standing doctrine.”  Id. at *6.  Well, duh.  That seems like a platitude.  Third, “legally protected interests” can be created by statute, including a state statute.  Id.  That also sounds platitudinous – except Cottrell separates that proposition from any injury.  That comes in the fourth factor – that “interest must be related to the injury in fact” as opposed to being “a byproduct of the suit itself.”  Id.

Having set up this thicket on its clean slate, the court’s actual analysis of the injury requirement’s application to overly large eye drop drips takes only a paragraph:

Plaintiffs claim economic interests: interests in the money they had to spend on medication that was impossible for them to use.  They seek monetary compensation for Defendants’ conduct that they allege caused harm to these interests.  Plaintiffs’ claimed interests arise from state consumer protection statutes that provide monetary relief to private individuals who are damaged by business practices that violate those statutes.  These claims fit comfortably in categories of “legally protected interests” readily recognized by federal courts.

Id. (citing Cantrell v. City of Long Beach, 241 F.3d 674, 684 (9th Cir. 2001)).  Wow!  At that level of generality, any claim that anything for any reason should have been made differently or priced differently confers standing.  That no such alternative product exists is of no bearing.  This breathtakingly broad holding means that the amount of harm to the “economic interest” being undefinable has no bearing.  That the “business practices” at issue were a consequence of the FDA-approved design of the product has no bearing.  These are presumably “merits questions” that court already divorced from standing by putting that rabbit in the hat in its “first” stroke on the blank slate – that merits don’t matter.

We’ve seen this sort of credulous avoidance of merits questions before in class actions before.  Remember how courts for decades misinterpreted Eisen v. Carlyle & Jacqueline, 417 U.S. 156 (1974), to find that class certification can’t look at the merits?  That was finally interred once and for all in Wal-Mart Stores, Inc. v. Dukes, 564 U.S. 338, 351 & n.6 (2011), but now we see it popping up again on this supposed standing blank slate.

It’s not really a blank slate, however.  The Third Circuit, and many other courts, have held that TwIqbal “plausibility” requirements apply to the analysis of standing questions.  “With respect to 12(b)(1) motions in particular, the plaintiff must assert facts that affirmatively and plausibly suggest that the pleader has the right he claims.”  In re Schering Plough Corp. Intron/Temodar Consumer Class Action, 678 F.3d 235, 244 (3d Cir. 2012) (applying TwIqbal pleading requirements to standing analysis in RICO drug pricing class action).  TwIqbal “teach that standing cannot rest on mere ‘legal conclusions’ or ‘naked assertions.’”  Finkelman v. National Football League, 810 F.3d 187, 194 n. 55 (3d Cir. 2016) (citation and quotation marks omitted).

Because Lujan mandates that standing “must be supported in the same way as any other matter on which the plaintiff bears the burden of proof,” it follows that the TwomblyIqbal facial plausibility requirement for pleading a claim is incorporated into the standard for pleading subject matter jurisdiction.  Lujan, 504 U.S. at 561.  Therefore, we join many of our sister circuits and hold that when evaluating a facial challenge to subject matter jurisdiction under Rule 12(b)(1), a court should use TwomblyIqbal’s “plausibility” requirement, which is the same standard used to evaluate facial challenges to claims under Rule 12(b)(6).

Silha v. ACT, Inc., 807 F.3d 169, 174 (7th Cir. 2015) (citing Schering Plough along with many other cases).  “Just as the plaintiff bears the burden of plausibly alleging a viable cause of action, so too the plaintiff bears the burden of pleading facts necessary to demonstrate standing.”  Hochendoner v. Genzyme Corp., 823 F.3d 724, 730 (1st Cir. 2016) (Iqbal citation omitted) (also providing string citation of TwIqbal standing cases).

Along these lines, we also point out that the sole citation in Cottrell supporting its one-paragraph injury in fact analysis, Cantrell, supra, is a Ninth Circuit case, and the Ninth Circuit is the only circuit that does not follow TwIqbal in standing cases. See Maya v. Centex Corp., 658 F.3d 1060, 1068 (9th Cir. 2011) (cited as lone exception in Silha).

Having thus improperly insulated the inherently ridiculous nature of the alleged injury from TwIqbal inspection on standing questions – without even mentioning TwIqbalCottrell then disagrees with Eike for precisely that reason.  To do so, Cottrell splits another hair – distinguishing business practices that are “unfair” under a consumer protection statute from those “that are fraudulent, deceptive, or misleading.”  2017 WL 4657402, at *6.

The plaintiffs in Eike explicitly alleged that the defendants’ practices in manufacturing and selling eye medication were “unfair”. . . .  The Court was obliged to take these allegations as true for purposes of the standing inquiry.


That is, to be charitable, garbage. “Unfair” by itself is your classic legal conclusion.  Under TwIqbal, legal conclusions have to be accompanied by some factual basis to survive dismissal.  Eike rightly pointed out that, in the absence of any allegation of anything false or misleading about how these products were marketed, an “unfairness” allegation amounted to mere “dissatisfaction with the defendants’ products or their prices.”  2017 WL 4657402, at *6 (describing Eike).

Having thus improperly given the plaintiffs’ inherently implausible theory on “legally protected interest a TwIqbal free pass, Cottrell also waved it through the other injury in fact factors it created.  Most interestingly – because of the dissent – Cottrell attempted to distinguish a prior standing precedent, Finkelman, supra.

[Plaintiffs’] pricing theory is far less speculative than . . . the theory of financial harm we rejected in Finkelman . . ., [where t]he plaintiff claimed that this policy reduced the number of tickets available in the resale market.  Under the basic economic principle of supply and demand then, the policy resulted in an inflated ticket price in the resale market, according to the plaintiff.  We rejected plaintiff’s theory, as the plaintiff pled no facts to support their assertion that [defendant’s] policy would actually reduce the number of tickets in the resale market.

Id. at *9.  Since a “reduced size” of the eye drop drip (produced by a different sized hole in the tip) was the “only change from the status quo” that plaintiffs’ theory in Cottrell required in the majorities eyes, it was less “speculative” than the too-remote theory in Finkleman, and thus “sufficient to satisfy the injury-in-fact requirement.”  Id. at *10.

The dissent saw things differently.  Finkleman was dispositive (“I believe that Finkelman all but decides this case”).  Cottrell, 2017 WL 4657402, at *12 (dissenting opinion).  “We properly recognized that markets operate in complex ways.”  The market forces in Finkleman “made clear that any potentially unlawful conduct by the [defendant] did not necessarily result in higher prices to the plaintiff” and “concluded that we have no way of knowing whether [defendant’s] withholding of tickets would have had the effect of increasing or decreasing prices on the secondary market.”  Id.

[F]or purposes of analyzing economic injuries in the context of marketwide effects, we cannot do precisely what the plaintiffs here ask of us:  isolate and change one variable while assuming that no downstream changes would also occur.  These cases . . . reflect courts’ skepticism about plaintiffs’ ability to satisfy the case or controversy requirement of Article III by relying on such imaginative economic theories.  Thus, contrary to the Majority’s assertion, the plaintiffs’ pricing theory does in fact depend on exactly the sort of presumption rejected by us and by other courts − namely, the presumption that no other aspects of the market would change once the defendants’ conduct did. . . .  Finkelman makes clear that [standing analysis] distinguishes “between allegations that stand on well-pleaded facts and allegations that stand on nothing more than supposition.” . . .  The plaintiffs . . . ask us to assume certain facts about other actors’ behavior − exactly the sort of assumption that cannot be proven at trial. Accordingly, I would reject the plaintiffs’ alleged economic injury as overly speculative and untenable under existing precedent.

Id. at *13 (multiple citation footnotes omitted).

The Cottrell dissent goes on to discuss multiple reasons why plaintiffs’ attenuated economic assumptions are “a particularly bad fit for the market for pharmaceuticals.”  Id.

  • Pharmaceuticals are not priced “by volume;” “unit-based pricing is too one-dimensional for the [pharmaceutical] marketplace.”
  • Pharmaceutical pricing is “value-based”; “measured in part by effective doses.”
  • This pricing “shift . . . sever[s] the link between volume and price upon which the plaintiffs’ alleged injury depends.”
  • “[T]he price of each bottle could actually increase if each bottle provided more doses.”
  • Because plaintiffs’ assumption “does not reflect market conditions and pressures in the pharmaceutical industry,” it would “draw an unreasonable inference about the downstream consequences of” the design change they are demanding.
  • “[U]nreasonable” inferences cannot be accepted “at face value.”

Id. at *13-14 (dissenting opinion).

The dissent is of the view that the majority’s decision conflicts with Finkleman.  We agree, but go further.  We think the entire construct in Cottrell conflicts with prior Third Circuit precedent applying TwIqbal in standing cases because of its holding that the merits – and thus the facts that must be pleaded to establish the “plausibility” of the claim on the merits – don’t matter in standing cases.  Cottrell thus represents, with In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017), the second abrupt pro-plaintiff lurch by the Third Circuit this year, which is less surprising than it might seem, considering the both of the judges in the majority in Cottrell also decided Fosamax.

About the only good thing that can be said about Cottrell is that it did not purport to decide that preemption issue that has also defeated these half-baked dropper drip size allegations.  Id. at *11.  That argument is that design changes affecting the dosage of medication delivered – which is necessarily what plaintiffs’ drop size allegations depend on – are “major” changes that require prior FDA approval, and thus are “impossible” to carry out with the immediacy that state law demands. See Gustavesen v. Alcon Laboratories, Inc., ___ F. Supp.3d ___, 2017 WL 4374384, at *5 (D. Mass. Sep. 29, 2017), and Thompson, 993 F. Supp.2d at 1013-13, as discussed in our prior posts.

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

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

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

What now?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Id. at 973-74.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Like many of you, on Friday mornings we turn to the “Legal Lions and Lambs” section of Law360.  It is not only voyeurism.  We are constantly working on things in media res (the middle of things), building slowly and gradually to a climax that  hardly ever arrives.  Ninety percent of cases settle, and that is seldom the stuff of Lions or Lambs. Nope: the Lions vs Lambs dichotomy is about winning and losing.  Not in any subtle sense, either.  The Law360 column focuses on trial verdicts or dispositive motions.  Those outcomes furnish teaching moments, points of inspiration, object lessons, or cautionary tales.  We have never personally shown up on either side of the list as far as we know, mirabile dictu (wonder to say – surely mastery of Latin is a mark of a Legal Lion, no?), given that we played a minor role in that vast stain on Anglo-American jurisprudence not-so-fondly remembered as the Engle tobacco litigation in Miami).
We know this much: we’d rather be a Lion than a Lamb. The Lion is king of the jungle. MGM pictures start majestically with a roaring lion.  King Richard was lion-hearted.  The hero in the best Disney animated movie was a lion. So was Barry Sanders.  By contrast, Lambs get led to the slaughter.  We count them as we try to fall asleep.  Their silence is the central image to the creepiest movie we have ever seen.  Worst of all, we garnish lamb chops with mint jelly.
Over the last couple of weeks, we saw some entries in the “Lambs” section that caught our attention because they involved lawyers we know and respect.  These lawyers defended drug or device companies that got tagged by juries with eye-popping verdicts.  These defense lawyers are, to put it plainly, great lawyers.  We co-tried, and won, a case with one of them, and counted two others as colleagues in the US Attorney’s office a long time ago.  Their skills are extraordinary.  They possess exquisite judgment, work hard, and give their clients the best possible representation.
And they lost the cases that landed them in Law360.  (One of them, by the way, had won a similar case a couple of months before – the first defense lawyer to do so.  Before he was a Lamb, this lawyer was a Lion). Suddenly, we decided that we disliked the “Lambs” label.  Law360 surely does not mean to insult anyone in the Friday column, but there is something undeniably negative about the “Lambs” term, and undeniably unfair.  We bet those lawyers on the losing end went down, not meekly, but swinging.
The fact is that great lawyers occasionally lose cases.  Why?  To begin with, great lawyers are given the hardest and most important cases.  We know a very smart in-house lawyer (in fact his company was involved with one of the cases that caught our attention in the Lions and Lambs column) who likes to ask lawyers begging for business from him to name their worst loss.  Too many lawyers pretend they have never lost, or immediately show their insecurity by ladling on the excuses. But think of the two or three best trial lawyers you have ever encountered.  Maybe there is a plaintiff lawyer in Houston with a photographic memory and unsurpassable eloquence. Maybe there is a corporate defense lawyer in Chicago who possesses laser-like focus and terrifying tenacity.  They have both been brutalized by juries. That is true for just about every other trial lawyer who has earned a glistening national reputation. Some cases are simply too hard. Some judges are simply too biased.  Or, most often, some juries are simply too batty.
When we consider our worst loss, we usually reflect on a near miss. (Right – we are cheating.)  We tried a case against one of the most unpleasant lawyers we have ever met.  You couldn’t trust his word.  He said things in open court that the Judge had explicitly ruled out of bounds.  But before violating the ruling, this lawyer would keep challenging it.  Again and again.  Every day was a new day.  (The rotten thing was that half the time the judge would give him something, as if that mollification would buy peace instead of inviting additional rounds of revisitations and defiance). He wasn’t a Lion or a Lamb.  He was a Weasel. The case was hard-fought, but we were sure we gave a bit better than we got, and our closing argument echoed Pericles (so we thought) while our villainous opponent cribbed his best lines from one of his competitor Texas plaintiff lawyers. His appeals to prejudice were utterly unoriginal. And plagiarism was the least of this scoundrel’s sins.  Be that as it may, it was now time to wait for the jury.  Our client, who was doubtless the smartest person in the room, took the plaintiff lawyer aside. They huddled and talked intently. One or two perplexing questions came from the jury.  Those questions were so unsettling as to provoke settlement. The in-house lawyer struck a deal with our adversary.  It seemed to us like a lot of money.   But there it was.


We informed the Judge. The Judge then informed the jury.  We then talked to the jury.  What they told us made none of us happy.  It seems that the jury was leaning toward awarding a verdict about ten times higher than the settlement. One member of the jury had been a bit, um, stealthy.  In voir dire she had disclaimed any relevant prior history at all.  It turned out that she had a daughter who suffered from a condition pretty similar to what the plaintiff claimed.  This juror pushed hard to become foreperson, and then pushed even harder for a punishing verdict.  We (the defense) were stunned.  But perhaps we weren’t quite as stunned as the plaintiff lawyer, who had bargained away his next vacation home.
We were almost Lambs.


There are lots of reasons why cases are won or lost, or settled.  We hate it when judges are outcome-oriented, and we should beware of that fault in ourselves, too.  The best lawyers don’t always get the best results.  We can think of a case where one of the finest, smartest, smoothest two or three trial lawyers we ever saw lost to one of the two or three dopiest, clumsiest ones we ever saw. The jury was moved by undeniable facts and unavoidable sympathy.
Let’s have a little sympathy for those Legal Lambs.  They might very well be much better than the Lions, and they probably did a better  job than most of us would have done.  Heck, they probably don’t want our sympathy.  They are much too tough for that.  They are not Lambs at all.