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Those of us who practice in the mass tort space spend vast portions of our professional lives dealing with our opponents’ experts. In our minds, we seek only to enforce the dictates of the Federal Rules and of the United States Supreme Court (and their esteemed state counterparts); to wit, to ensure that experts are  qualified to render the opinions they offer and that they arrived at those opinions through reliable methodologies.  But, so very often, we face the fact that experts can say virtually anything they want with impunity (and most often without even being excluded).  We say “virtually” because we learned today, with horror (and, we confess, with some amusement), that even this regrettable reality has its limits.

Today’s case, Ruehl v. S.N.M. Enterprises, 2017 WL 5749560 (M.D. Pa. Nov. 28, 2017), is not a drug or device case.  It is a slip-and-fall case, but it illustrates the outer limits of a court’s tolerance for an expert’s misconduct and the consequences of straying beyond those bounds.  In Ruehl, the plaintiff’s decedent, his elderly wife, died as she attempted to pass through automated sliding glass doors into the defendant’s hotel.  The plaintiffs alleged that the sliding glass doors struck the decedent as she passed them, knocking her off balance so she fell and hit her head on concrete.  The defendant contended that the decedent simply lost her balance and fell.

The plaintiffs hired an expert who asserted that he was “a premier expert witness in the field of automated sliding glass door technology.” Ruehl, 2017 WL 5749560 at *2.   The expert’s retention agreement provided that he “retain[ed] the right to approve video deposition[s],” but, as the court noted, did not “foreshadow[] [the expert’s] curious and categorical refusal to comply with court orders, or attend video depositions.” Id. After the fact (and we’ll tell you more about what led up to this), the expert filed a declaration stating that he “generally refuse[d] to allow videotaped depositions” but “on one occasion allowed such a deposition provided that [his] face was not shown,” id. (internal punctuation omitted), a condition that “apparently stem[med] from some concern on [the expert’s] part that unknown and unnamed persons [would] digitally alter the video in ways that [would] be detrimental to [him].”  The court commented, “In nearly four decades of legal practice devoted exclusively to federal court litigation, we have never encountered such an idiosyncratic view by any lay or expert witness . . . .” Id.

But, to get back to the story, the plaintiffs’ counsel apparently learned of the expert’s opposition to being videotaped about two years into the litigation, after they had paid the expert more than $20,000 for his services. Some months later, the defendant scheduled a videotaped deposition of the expert, which, as the court emphasized, “they were entitled to do under the Federal Rules of Civil Procedure.” Id. at *3.   The expert demanded from the defendant, and accepted, a $3,050 prepayment of his fee for the deposition, while simultaneously notifying the plaintiffs’ attorneys that he would not voluntarily agree to participate in the deposition.

The plaintiffs’ attorneys moved for a protective order and “vigorously advocate[ed] on [the expert’s] behalf.” Id. at *3.  But the court reached the obvious conclusion, denying the protective order and ordering the expert to sit for a videotaped deposition.  And the court limited use of the deposition to the litigation, thereby (lol) “address[ing] [the expert’s] odd and speculative concern that his words and visage would be digitally altered by unknown sinister actors . . . .” Id.

As the court explained, the order gave the expert the choice among complying with the order, seeking timely reconsideration of it, or initiating motion practice (for a protective order or to quash the deposition subpoena) through an attorney of his own. “The one thing he could not do, however, was to engage in some unilateral, passive-aggressive course in which he ostensibly agreed to schedule a deposition, while privately evading his basic obligation owed by all witnesses by failing to appear for that deposition.  Yet that is precisely the path that [he] chose.” Id.

First, according to “testimony and contemporaneous notes of plaintiffs’ counsel,” when the expert was informed that the court had denied the protective order, he responded, “I don’t care about you or [the decedent] or some a****** judge.” Id. And, when the plaintiffs’ counsel implored the expert to cooperate because the family of the decedent was counting on his testimony, he replied, “Nothing will bring her back, so I don’t give a s***.” Id. But “at the same time that [the expert] was presenting his refusal to participate in the videotaped deposition in profane terms as some matter of principle, he was also willing to forego that principle for a price.” Id. at *4.  Specifically, as the expert admitted, he told the plaintiffs’ counsel that he would sit for the deposition if they provided him with a $10,000,000 Lloyds of London indemnity bond.  “Plaintiffs’ counsel understandably discounted this bizarre and extortionate suggestion.” Id.

Simultaneously, and in spite of all of this, the expert’s office manager – also his wife – was making scheduling arrangements for the deposition, on a date and at a location that the expert specifically approved.   Deposition time arrived, and – wait for it – the expert didn’t show up.  Ultimately, the plaintiffs were “compelled to negotiate a settlement of [the] lawsuit from a highly disadvantageous position,” since their expert had abandoned them. Id. The defendant moved for sanctions, and the plaintiffs ended up joining the motion.  That’s right, both sides were seeking sanctions against the same expert.  The expert responded and (lol lol) filed a motion for sanctions against the plaintiffs’ law firm.

In a victory for all that is good and right – and obvious – the court granted the parties’ joint motion for sanctions and denied the expert’s cross-motion. The court found that the expert’s conduct “involved a dual dereliction of the duty of candor and cooperation that [he] owed to [the] court, as well as the duty of loyalty [he] owed to his clients who had paid him more than $20,000 and were relying on him to provide crucial expert testimony in this case.” Id, at *7.  The court concluded,

Thus, [the expert’s] pattern of misleading conduct designed to frustrate this court’s order and the discovery process, coupled with his openly voiced contumacious disdain for his responsibility to the court and his own client, is sanctionable as contempt . . . . But perhaps most egregious of all is the disservice which [the expert] did to his clients, . . . an elderly couple who had retained his services to assist them in this litigation. . . . While [the expert] may be completely indifferent to the plight he created for the [plaintiffs], we are not. Therefore, [we will impose sanctions] in an effort to assist [the expert] in locating his moral, legal and ethical compass . . . .

Id. at *8.   (Note to selves:  look for other opinions by this awesomely pithy judge.)

The court did not order the expert to repay his entire $20,000 fee, finding that such a sanction would not be “narrowly tailored, as required by law,” because the expert had provided some professional services before the episode began. But the court asked the plaintiffs’ attorneys to submit an accounting of all time and expenses broadly related to the expert’s misconduct.  In addition, the court ordered the expert to repay the defendant for deposition fees and expenses totaling almost $5,000.  Finally, and best of all, finding that “[the expert’s] conduct in the instant case may be relevant to a consideration of his continued licensure by the state and membership in [the American National Standards Institute (ANSI)],” the court ordered that a copy of the decision be forwarded “to the appropriate licensing and professional association officials for whatever action they may deem appropriate.” Id., at *9.

All in all, a horror show, and we feel sorry for all of the parties. But kudos to the judge for decisive action (and cool rhetoric), and a cautionary flag to any other expert whose sense of omnipotence may be similarly ballooning.  We’ll watch for other decisions of this ilk, and we’ll keep you posted.

In the mass torts world in which we find ourselves, glimmers of jurisprudential light can seem few and far between. Two things we love are good warnings causation decisions and sneaky plaintiffs getting caught at their own games.  Today’s case has both.  In Thompson v. Janssen Pharm., Inc., 2017 WL 5135548 (C.D. Cal. Oct. 23, 2017), the court considered simultaneous motions:  the plaintiffs’ motion for voluntary dismissal without prejudice and the defendants’ motion for summary judgment.

The plaintiff began taking Risperdal in 2001 after he was diagnosed with tics and other disorders, and he alleged that the drug caused him to develop gynecomastia (breast enlargement). Nevertheless, he continued – and continues – to take Risperdal (sixteen years, five doctors, and counting) because it effectively controls his tics, notwithstanding his alleged gynecomastia, his lawsuit, and his doctor’s recommendation that he stop taking the drug.

The Plaintiffs’ Motion for Voluntary Dismissal without Prejudice

The plaintiffs sued in the Central District of California, asserting the usual litany of claims. One day before the defendant moved for summary judgment, the plaintiffs moved for voluntary dismissal without prejudice so they could re-file their case in state court and park it in the already-existing JCCP, California’s version of an MDL.  They claimed that, though they had “been diligently seeking discovery” to prove their case, they were “unable to do so effectively” in federal court. Thompson, 2017 WL 5135548 at *4.

The court explained that factors relevant to its decision included: 1) the opposing party’s effort and expense in preparing for trial; 2) excessive delay and lack of diligence by the moving party in prosecuting the action; 3) insufficient explanation of the need for dismissal; and 4) the fact that the opposing party has moved for summary judgment. Id. at *5 (citations omitted).  Naturally, the plaintiff argued that all of these factors weighed in favor of granting the motion, but the court disagreed.

The court pointed out that, though the plaintiffs argued that they had been diligent in prosecuting his case, they had “failed to serve expert disclosure or expert reports.” Id. at *6.  Moreover, through the plaintiffs’ motion was “purportedly premised on their intention to join the pending state court [Risperdal litigation],” they gave “no explanation as to why they waited until . . . mere days before the summary judgment deadline” when they had notice of the state court litigation for more than a year. Id. The court concluded that this was “an insufficient explanation of the need for dismissal,” one of the factors to be considered. Id. (internal punctuation omitted).

In addition, though the defendants’ motion for summary judgment was not pending when the plaintiffs filed their motion (it was filed the next day), the defendants had notified the plaintiffs that they would be filing for summary judgment before the plaintiffs moved for dismissal. The court held that “the proximity of the two motions raise[d] the inference that that Plaintiffs’ motion might have been motivated by a desire to . . . avoid an imminent adverse ruling by way of Defendants’ summary judgment motion and also avoid the consequence of their failure to serve expert disclosures.” Id. (internal punctuation and citation omitted).

Simply put, as the court correctly perceived, the plaintiffs’ tactic was a transparent attempt to hide their meritless case in another mass proceeding on the chance that an inventory settlement would line their pockets at some point down the road.  The court concluded, “. . . Plaintiffs have not provided sufficient justification for voluntary dismissal given the untimeliness of the request and the proximity to Defendants’ motion for summary judgment.” Id.  Motion denied.

The Defendants’ Motion for Summary Judgment

It was undisputed that all of the plaintiffs’ claims were premised on the defendants’ alleged failure to warn about the rate of gynecomastia. As such, the defendants argued that all of the plaintiff’s claims failed because, inter alia: 1) the plaintiff assumed the risk by continuing to take the drug once he was aware of the alleged risk; and 2) the plaintiff could not prove “warnings causation;” in other words, he could not satisfy his burden of proving that that a different warning would have changed his doctors’ decisions to prescribe the drug for him. Id.

As to assumption of the risk, the defendants argued that the plaintiff was aware of the risk of gynecomastia but “continues to use Risperdal because he believes the benefits of the medicine in treating his condition outweigh the very risks that he has sued upon.” Id. at *7 (citation omitted).  The court disagreed, holding that the record did not clearly indicate that the plaintiff’s treating physicians discussed the risk of gynecomastia with the plaintiff.

But it was clear, on the record, that all of the plaintiff’s prescribing physicians were themselves aware of the risk of gynecomastia. And the plaintiff “provided no evidence that a different warning would have altered the physicians’ decisions to prescribe Risperdal.”  Therefore, the plaintiff could not “demonstrate the [warnings] causation required to survive summary judgment under California’s learned intermediary doctrine.” Id. at *8.

Nor were the plaintiffs’ claims saved by California’s “overpromotion exception.” As the court explained, “California courts have in the past recognized that the learned intermediary doctrine may not apply where a medication has been overpromoted to the extent that any warnings would have been nullified.” Id. at *9 (citation omitted).  But the overpromotion exception applies only in “unusual cases” (our California colleagues tell us that it is very rarely applied), and not “where a plaintiff’s prescribing physician did not rely on promotional statements when choosing treatment options.” Id. (citation omitted).  In this case, there was no evidence that any of the plaintiff’s prescribers relied on the defendant’s promotional activities, and the exception did not apply.

And so, in the absence of evidence of warnings causation, the court granted summary judgment for the defendants. The correct result, and a nice cautionary tale for plaintiffs thinking they can game the system, ignore both rules and law, and await the filling of their outstretched hands.  Does our defense heart good.

As we write this, our fair city remains in a blissful haze following our Eagles’ 33-10 rout of the 49’ers to go 7-1 in the NFC East, so it might be appropriate to call today’s opinion a “touchdown.” On the other hand, the World Series approaches Game 6, following a game in which twenty-five runs were scored.  So maybe the opinion is a “home run.”  In any event, the Second Circuit’s (regrettably) unpublished affirmance in In re Mirena IUD Prods. Liab. Litig., Mirena MDL, Plaintiffs v. Bayer Healthcare Pharmaceuticals, Inc., 2017 U.S. App. LEXIS 20875 (2d. Cir. Oct. 24, 2017) is very, very good.

More than a year ago , we reported that the United States District Court for the Southern District of New York granted the defendant’s motion to exclude the plaintiffs’ general causation expert in the Mirena MDL.  In the absence of expert causation testimony, the court granted summary judgment for the defendant on all pending cases, holding that the plaintiffs could not satisfy their burden of proof without expert causation testimony.  The plaintiffs appealed to the Second Circuit.

Mirena is an implanted intrauterine birth control device. (As we have commented before, plaintiff lawyers persist in choosing contraceptive devices as their targets, despite the general absence of any basis for the plaintiffs’ claims.)  The Mirena MDL plaintiffs alleged that they were injured when their Mirena devices perforated their uteruses.  As the Court explained, “At bottom, the [Mirena] MDL is about when Mirena perforated Plaintiffs’ uteruses.  Both parties agree – and [the defendant] has warned – that Mirena can injure a woman’s uterus during insertion and afterward migrate outside the uterus (what is called “primary perforation”). Mirena, 2017 U.S. App. LEXIS 20875 at *2 (emphasis in original).  But the plaintiffs alleged that their Mirena devices perforated and migrated outside their uteruses at some later time (so-called “secondary perforation”).  The defendant did not warn of “secondary perforation,” so, the Court stated, it was “exposed to liability if secondary perforation in fact occurred.” Id.

The plaintiffs offered three general causation experts to testify that secondary perforation was possible. The District Court excluded all three pursuant to Daubert, holding that their testimony was “not reliable and, thus, not helpful to the trier of fact.”

Affirmance of Exclusion of Plaintiffs’ General Causation Experts

On review of the District Court’s Daubert decision, the Second Circuit focused on three “particularly noteworthy” problems with the opinions of the plaintiffs’ experts. Id. at *5.  First, the experts’ theories were not accepted in the relevant scientific community. “Not only [did] the experts fail to identify any authorities that directly support the existence of secondary perforation, but what scientific authority there is casts doubt on the phenomenon’s existence.” Id. Second, all of the experts developed their “secondary perforation” theories solely for purposes of the litigation and lacked in the supposed phenomenon before the litigation began.  One had no specialized expertise in Mirena or uterine perforation before being hired, one had no experience with IUDs, and the third “had not even heard of secondary perforation before consulting in the litigation.” Id. at *8.  Third, “finding no direct support in the literature for secondary perforation and having conducted no prior research on the subject, the experts all assumed the existence of the very phenomenon in dispute and then hypothesized how it could occur.” Id.

In response to the third point, the plaintiffs argued that their experts were no different than experts in Kumho Tire v. Carmichael, 526 U.S. 137 (1999), who were asked to determine the mechanism that caused the blowout of a tire.  The Court gave this argument the back of its figurative hand, emphasizing, “. . . [I]n Kumho, there was no dispute about whether the tire had blown, only how it happened. . . . Here, by contrast, the parties dispute whether the secondary perforation has ever occurred.  The experts thus begged the very question they were trying to answer.”   Id. (citations omitted).

And so the Court affirmed the exclusion of all three general causation experts.   Next, the Court considered whether the plaintiffs could escape summary judgment despite the lack of expert causation testimony.

Affirmance of Summary Judgment for Defendants

Arguing that their cases could survive the exclusion of their experts, the plaintiffs “identif[ied] dicta from several cases suggesting that party admissions can sometimes substitute for expert testimony on general causation.” Id. at *9-10.  The plaintiffs proffered four categories of such supposed admissions:

  • Three short excerpts of emails authored by the defendant’s employees that purportedly “admitted” that secondary perforation could occur. But the excerpts were from emails in which the employees “reported, without necessarily endorsing, adverse event reports,” which, as a category, are “anecdotal, and thus of very limited probative value.” Id.
  • One sentence from a PowerPoint presentation suggesting that spontaneous perforation could occur unrelated to insertion. The Court agreed with the District Court that, with no knowledge of the context in which the slide was presented or what was said at the meeting, and no details of any causes of the supposed secondary perforation, the excerpt could not substitute for expert testimony.
  • Testimony from the defendant’s Global Medical Expert that “a perforation unrelated to insertion, rare as it may be . . . could happen.” The Court held that “acknowledgment of the possibility of causation does not establish that causation is more likely than not, as the District Court correctly found.” Id. at *11.
  • In 2014, the defendant changed the Mirena label to warn that perforation “may occur most often during insertion, although the perforation may not be detected until sometime later.” The plaintiff’s argued that this was an admission that secondary perforation could occur, but the Court observed that “the grammatical structure [of the warning was] cryptic at best,” at most “suggest[ing] the hypothetical possibility of secondary perforation,” and could not substitute for expert testimony. Id. at *11-12.

And so, the Court held, “We need not reach the question of whether party admissions could ever substitute for expert testimony.   Assuming arguendo that they could, the putative admissions proffered by Plaintiffs are simply not enough to establish general causation.” Id. at *10.  Summary judgment for the defendant affirmed.

Daubert embodies real standards. And the Rules of Evidence are more than suggestions.  In this case, in the hands of a decisive District Court, both contributed to a decision that was unassailable on appeal.  We will keep you posted on similar – and hopefully published – decisions.

Recently, in downsizing our elderly father to a smaller residence and cleaning out his house, we came upon a cassette recording of our too-many-decades-ago Bat Mitzvah. We dug an old boom box out of the basement, listened to our sweet 13-year-old voice, and allowed the waves of nostalgia to wash over us.  We remembered the dress we wore (pink and white) and the upturned faces of our proud relatives (including all four grandparents, the first of whom would depart the very next year).  We recalled the home-cooked food at the “open house” at our home that evening (this was a different era – and tax bracket – than those occupied by cousins who have recently thrown six-figure extravaganzas for their children’s events) and the elusive (for us) sense of religious affiliation. For the thirty minutes of that cassette tape, we were transported.

Our love of nostalgia is neither new nor news. Readers of this blog know how much we love revivals of old Broadway musicals (recent:  South Pacific, Pippin, Finian’s Rainbow, Hello, Dolly; upcoming:  Carousel, My Fair Lady), and we will wax nostalgic in Connecticut this weekend at our 30th law school reunion (Guido’s torts class anecdotes, anyone?).   And we had a wistful flash when we read today’s case.  A decade ago, we were enmeshed in the earliest stages of a mass tort MDL.  Plaintiffs routinely filed in state court and, seeking to evade federal jurisdiction, sued a distributor domiciled in the state of filing (a “forum defendant”) along with our client, the manufacturer.  Trajectory permitting, we would sweep in and remove those cases before the forum defendant was served.  We called these “wrinkle removals,” because a “wrinkle” in the removal statute opened this window for us.

As one of our co-bloggers recently explained, this blog has been posting about “removal before service” since Bexis brought it to the attention of the legal community in 2007.  It’s a procedural tactic that enables defendants to remove cases to federal court despite the “forum defendant rule,” which ordinarily prohibits a defendant from removing to a case that, while it meets the requirements of diversity jurisdiction under 21 U.S.C. § 1332(a), is also pending in the home state of the defendant. Here’s the rule as codified in 21 U.S.C. § 1441(b) (2):  “A civil action otherwise removable solely on the basis of the jurisdiction under section 1332(a) of this title may not be removed if any of the parties in interest properly joined and served as defendants is a citizen of the State in which such action is brought.” (Emphasis added).

A review of our long chain of posts on this subject reveals dramatic splits among, and even within, district courts (notably, the Eastern District of Pennsylvania) on this issue. Some courts acknowledge the plain language of the statute and deny remand, while others remand in the supposed “spirit” of diversity jurisdiction.  Last week’s Southern District of New York decision in Cheung v. Bristol-Myers Squibb Co., et al., 2017 WL 4570792 (S.D.N.Y. Oct. 12. 2017), one of the best opinions we have read on this issue, falls resoundingly in the former category.  In Cheung, the court explained that, in response to the Eliquis MDL court’s dismissal, on preemption grounds, of the first case subject to a 12(b)(6) motion, plaintiffs’ counsel voluntarily dismissed thirty-three cases and re-filed them in Delaware state court.   The defendants removed them to the United States District Court for the District of Delaware, and the judge there denied motions to remand all thirty-three cases, holding that removal was proper despite the presence of a defendant domiciled in Delaware.  The same plaintiffs’ firm filed four more actions in Delaware state court, and the defendants removed those, too, and tagged them for transfer to the MDL in the Southern District of New York.  The plaintiffs waited to move for remand until the cases were transferred to the MDL, then moved to remand all four.

Denying the motions to remand, the court emphasized that “the [removal] statute prohibits removal when there are in-state defendants only when those defendants have been ‘properly joined and served.’ The specific purpose of the ‘joined and served’ requirement has been read to prevent a plaintiff from blocking removal by joining as a defendant against whom it does not intend to proceed and who it does not even serve,” Cheung, 2017 WL 4570792 at * 3 (internal punctuation and citations omitted), precisely the description of the distributor defendant in our long-ago MDL.  Noting that it was “undisputed that the defendants removed the cases before they were properly served,” id., the Court held that “a plain reading of the forum defendant rule” permitted removal. Id.

The plaintiffs “urge[d] the Court to ignore the plain reading of the statute to discourage what they term[ed] ‘gamesmanship’ by the defendants,” id., suggesting that the statute “should only be enforced when a removal occurs after a plaintiff has had a ‘meaningful chance’ to serve the [forum] defendant.” Id. They argued that upholding the removals, “which they contend[ed were] strategically done in order to evade the forum defendant rule, would be to frustrate the purpose of both diversity jurisdiction and the forum defendant rule.” Id.

But the court refused to bite. As the court emphasized, “It is well and long established that courts apply the plain meaning of unambiguous statutory language. . . . The plain language of Section 1441(b) makes clear that its ‘prohibition’ on removal applies only where a defendant who has been ‘properly joined and served’ is a resident of the forum state.” Id. at *4 (citations omitted, emphasis in original).   The court continued, “Ignoring the plain terms of the statute to determine in an individual case when a plaintiff has had meaningful opportunity to serve each defendant and to investigate the parties’ motives . . . would add expense, delay, and uncertainty to the litigation.  In cases like the ones at issue here, the investigation is complicated and points in several directions.  While the defendants no doubt removed the actions swiftly [before the forum defendant rule would prohibit removal], a ruling in favor of the plaintiffs on the issue of removal would reward a different type of gamesmanship altogether.  Instead of promptly moving before [the District of Delaware] for remand of [these] four cases, . . . [the plaintiffs] waited until the JPML had ordered the transfer to move for their remand, . . . hop[ing] for a different result.”  Id.  The court concluded, “If the plaintiffs, then, urge an interpretation of the removal statute that takes the litigants’ strategies into account, theirs may not be ignored.” Id. Remand denied, and all four cases dismissed under the same preemption arguments that had previously prevailed.

We just love this stuff. It combines all the elements that, on a good day, make this a fun job – hornbook statutory construction, chutzpah, a confident judge, and questionable opponents.  We will continue to follow the trail of this doctrine and will hope that more judges veer down this fork in the jurisprudential road.

A couple of weeks ago, we reported that, under pressure from the Drug and Device Law Rock Climber, we were headed to New York to see the Broadway production of Orwell’s 1984. Publicity surrounding this spectacle focused on audience members fleeing, fainting, and/or vomiting during the torture scene.  Incautiously well-fed (Vietnamese/Thai food from a singularly memorable Hell’s Kitchen bistro) and more than a bit apprehensive, we made our way into the theatre, where the assault on our senses began with a disconcerting background hum that continued until the curtain rose.  Whereupon ensued two hours of blinding flashes of light, lots of crashing sounds, plenty of blood, and some pretty cool dental torture.  We did not vomit, faint or flee.  And we liked the show more than we expected to, though we typically lean toward “happy” – the lauded and wonderful but lamentably short-lived recent revival of Finian’s Rainbow at Lincoln Center was right up our alley.

We thought about 1984 as we read today’s case. We are old enough to remember when a defendant had to hire a private investigator to play “Big Brother” and tease out deception in a plaintiff’s account of her limitations following an injury.  Nowadays, so-called “social media” have stepped in, in large measure, to fill those shoes, and discovery requests now commonly seek production of and access to those resources.

In In re: Cook Med., Inc., IVC Filters Mktg., Sales Practices & Prod. Liab. Litig., 2017 U.S. Dist. LEXIS 149915 (S.D. Ind. Sept. 15, 2017), the court addressed several discovery motions in a bellwether case approaching trial.  First, as a sanction for the plaintiff’s failure to produce a privilege log, the defendants sought an order holding that the plaintiff had waived all privilege objections.  The court denied the motion, finding that “a blanket waiver is not an appropriate sanction when the party seeking protection makes a good faith showing that the requested material is privileged.”  2017 U.S. Dist. LEXIS 149915 at *3.

Second, the defendants sought to compel responses to discovery requests to which the plaintiff had objected as overbroad because the defendants had defined “you” to include the plaintiff, her attorneys, and her representatives. The court said that this “fail[ed] to move” it because (we love this) “half of the interrogatories and responses in question do not even contain the word ‘you.’” Id. at *4.  Motion granted.

Third, the court properly held that the plaintiff waived objections she had failed to assert in her discovery responses, although it declined to order the plaintiff to produce all requested materials (which included emails between the plaintiff and her attorneys) irrespective of claims of privilege.

Fourth, the court addressed the defendants’ motion to compel the plaintiff to produce her Facebook profile and various posts in native file format though she had already produced them in PDF. The court declined to order production of all of the requested materials in native format and held that the defendant would be required to make a showing of its need for the metadata in the native file of any particular post.

Finally, the court turned to the scope of the defendants’ social media requests, which, it noted, had occupied much of the space in the parties’ briefs. First, in their brief, the defendants sought to compel the plaintiff’s social media log-in credentials, including her passwords.  Noting that the defendants already possessed the plaintiff’s usernames, the court held that the original interrogatory did not expressly seek passwords; as such, it declined to “compel a response to an interrogatory that does not exist.” Id. at *10.  But it dropped a footnote emphasizing that it would not likely have compelled the plaintiff to disclose her passwords in any event because it “struggle[d] to see how such staggering access [to the plaintiff’s private accounts] would be proportional to the needs of the case.” Id. at *10 n.6. The court elaborated, “The requesting party does not have an unfettered right to rummage through the responding party’s social media,” without a showing of relevance and appropriate limits on content and time period. Id. at *11.

To wit, the defendants next moved to compel the plaintiff’s private social media data related to her travel, social activities, medical conditions, and alleged damages. Noting that, because the plaintiff claimed loss of enjoyment of her life, depression, and continuing medical issues, the defendants would have been entitled to compel a response to interrogatories seeking the same information, the court granted the defendants’ motion.

Finally, the court declined the defendants’ request for screenshots of all of the plaintiff’s social media webpages from the date of her implantation with the defendants’ device to the present date, holding that the request was doomed by the lack of a content limitation. The court explained, “If the motion were granted, Plaintiff would have to turn over a screen shot of every private message she sent to anyone on any topic simply because she sent it after implantation.” Id. at *13.

In the end, an attenuated cautionary tale for anyone planning to sue anyone: while a court may not hand the opponent the figurative keys to your entire online life, postings that can be tied to your claims will find their way into your opponents’ hands, whether you posted them “privately” or not.

By the way, we just got tickets for the upcoming revival of Carousel, starring Jessie Mueller, whom we loved in Beautiful and Waitress. There will be no bloody tooth-pulling, and there will definitely be a show-stopping rendition of “You’ll Never Walk Alone.”  We can’t wait.

A couple of weeks ago, our co-blogger, Mr. McConnell, published a post on the benefits of brevity.  That post sprang from an argument before the JPML, but we can riff on it today as we examine a short and lovely decision from the Northern District of New York.  We have all suffered through opinions in which judges (or their clerks) painstakingly flog possible outcomes, arguments, and counter-arguments before finally reaching their decisions. And as (once again) McConnell recently pointed out, the result has been some spectacularly bad preemption decisions.  But Olmstead v. Bayer Corp., 2017 WL 3498696 (N.D.N.Y. Aug. 15, 2017), arising in the relatively clear jurisprudence surrounding so-called “PMA preemption,” was what we fondly call a “slam-dunk,” and the court treated it accordingly.

In Olmstead, the plaintiff was implanted with an Essure device, an implantable birth control device manufactured by the defendant.  She alleged that, after she was implanted with the device, she experienced months of pain, fatigue, and excessive bleeding culminating in a hospital visit for an episode of severe abdominal pain.  Though an initial ultrasound appeared normal, a subsequent ultrasound allegedly revealed that “one of the coils of the Essure was sticking out of the uterus by about one inch.” Olmstead, 2017 WL 3498696 at *2 (internal punctuation and citation omitted).  The plaintiff sued in state court, asserting claims for negligent misrepresentation, strict liability, failure to warn, and breaches of express and implied warranties.   The defendants removed the case to federal court and moved to dismiss it, arguing that the plaintiff’s claims were preempted by the Medical Device Act (“MDA”).

As the court explained (and as we have discussed in these pages many times before (like here, also in the context of Essure litigation), Class III medical devices like Essure must undergo FDA’s “rigorous” premarket approval (“PMA”) process before they can be marketed to the public. Id. at *1.  Under the MDA, once a Class III device obtains PMA, the manufacturer may not make changes to the device’s design, specifications, or labeling without FDA permission.

The MDA also includes an express preemption clause. Under this clause, as construed by the Supreme Court in Riegel v. Medtronic, 522 U.S. 312 (2008), state laws that impose obligations that are different from or in addition to the requirements of the MDA are expressly preempted. Id. at *3 (citations omitted).  A common-law claim challenging the safety of an FDA-approved medical device survives only if it alleges a parallel violation of federal law for which state law provides a damages remedy.  Id. (citations omitted).

As such, the Olmstead court explained, the plaintiff’s “onerous task” first required her “to identify a parallel federal law upon which she [had] based her state law claims.” Id. at *4.   In response, the plaintiff cited the Current Good Manufacturing Processes (“CGMPs”) described in 21 CFR § 820.1 et seq..  But she failed to explain how the defendants had violated the CGMPs, which, in any event, were intended “to serve only as an umbrella quality system providing general objectives medical device manufacturers must seek to achieve.” Id. (internal punctuation and citations omitted).  The court emphasized, “Since these regulations are open to a particular manufacturer’s interpretation, . . . allowing a suit to continue on the basis of the CGMPs would necessarily impose standards that are ‘different from, or in addition to’ those imposed by the MDA – precisely the result that the MDA provision seeks to prevent.”  Id. (internal punctuation and citations omitted).

Thus, the court held, because the plaintiff had “failed to identify a single parallel federal statute or regulation related to any of her claims,” the MDA expressly preempted the suit as a matter of law. Id. The court commented that it ordinarily would have allowed the plaintiff to amend her complaint to “attempt to allege a plausible claim that [was] not preempted.” Id. But, in yet another layer of certainty, the court held that New York’s three-year statute of limitations barred the plaintiff’s claims.

Nothing but net. And we are told that this is the twenty-fourth time that an Essure suit has been dismissed or narrowed on preemption grounds.  Short, sweet, and correct – hard to beat that.  We will keep you posted on further developments.

We write this in the first minutes of the eclipse, about 75 minutes from whatever “totality” will be visible here in southeastern Pennsylvania. We have our certified safety glasses at the ready, we have instructed the midday dog-walker to keep the Drug and Device Law Little Shaggy Rescues indoors (lest they unwittingly look skyward), and we have a continuous loop of the Fifth Dimension’s “Age of Aquarius” going around in our head. (Parenthetically, we accidentally typed “Fifth Amendment” just then for the name of the band.) The song has nothing to do with the eclipse, but it talks about the moon. And about Jupiter aligning with Mars. Appropriately thematic, we thought.

And, while “love steering the stars” may be a little strong to describe recent activity in Risperdal litigation, we have been pleased by a recent spate of positive developments. Last week, Bexis reported on two favorable decisions out of federal courts, one a post-BMS personal jurisdiction denial and the second a refusal to consolidate dissimilar cases for trial. Today we round out the triumvirate with a nice summary judgment decision from Pennsylvania’s state court system.

In In re: Risperdal Litigation: P.D. v. Janssen Pharmaceuticals, Inc., 2017 Phila. Ct. Com. Pl. LEXIS 231 (July 26, 2017), the (male) plaintiff allegedly developed gynecomastia – excessive breast tissue – when he was prescribed Risperdal (beginning when he was eight years old). He sued, including claims for design defect, failure to warn, and fraud. The defendant won summary judgment. The published decision occurs in a peculiar posture that is a creature of the Pennsylvania Rules of Appellate Procedure. Under Pa. R.A.P. 1025, when a grant of summary judgment is appealed, the trial judge prepares a written opinion in support of affirmance, arguing that there were adequate grounds for the summary judgment decision.

Design Defect

First, the court addressed the plaintiff’s design defect claims sounding in both strict liability and negligence. Because there were unresolved choice-of-law issues, the court considered these claims under the laws of both North Carolina, where the plaintiff was prescribed Risperdal and developed gynecomastia, and Pennsylvania, the forum state. Both states prohibit strict liability design defect claims against pharmaceutical manufacturers. While Pennsylvania, since Lance v. Wyeth, permits claims for negligent design defect, “a drug manufacturer can shield itself from liability for the design of drugs by including appropriate warnings; however, when it becomes known that a drug should not be used in light of the relative risks, the manufacturer can only avoid liability by removing it from the market.” P.D., 2017 Phila. Ct. Com. Pl. LEXIS 231 at *8-9. Here, the plaintiff did not offer “any evidence that Risperdal was so dangerous no warning could mitigate the relative risk of gynecomastia.” To prevail on a negligent design defect claim under North Carolina law, the plaintiff was required to submit evidence of a safer alternative design, and he had not “even address[ed] this requirement . . . , let alone submit evidence of a safer alternative design for Risperdal.” Id., at *9. As such, the court held, the plaintiff’s negligent design defect claims also failed under either body of applicable law.

Failure to Warn

The court’s dismissal of the plaintiff’s warnings claims rested on a finding that the plaintiff had not met his burden, under either North Carolina law or Pennsylvania law, of proving “warnings causation;” in other words, he had not proven that any alleged inadequacy of the product’s warnings was causally related to the his injury. We love this doctrine, because a successful argument can turn on the opportunistic exploitation of a plaintiff’s lawyer’s failure to ask a single question when deposing the plaintiff’s prescribing physicians.

The plaintiff’s warnings expert opined that the 2006 Risperdal label, in effect when the drug was prescribed for the plaintiff, should have included: 1) a recommendation for physicians to monitor prolactin levels; and 2) an indication that there was a statistically significant association between Risperdal use and gynecomastia. Id. at *12. But, as the court explained, “[a]lthough the parties deposed Plaintiff’s prescribing physicians, neither party elicited any testimony from [the doctors] concerning whether [the expert’s] proposed warnings . . . would have affected their prescribing decision.” Id. And so, the court concluded, “In light of the dearth of testimony from his prescribing physicians that [the expert’s] proposed warnings would have changed their prescribing decision, Plaintiff failed to establish proximate causation.” Id. (citation omitted).

The plaintiff attempted to save his warnings claim by arguing that the defendant engaged in illegal off-label promotion. The court held that, because the plaintiff was in an indicated population and was prescribed the drug for an indicated use, any discussion of off-label promotion was irrelevant to the case.

Fraud

Finally, the plaintiff argued that the court erred in dismissing his fraud claim. Again the court considered this claim under both North Carolina law and Pennsylvania law. Federal courts have interpreted Pennsylvania law as ‘barring [fraud claims]against pharmaceutical manufacturers.” Id. at *18 (citations omitted). Pennsylvania appellate courts have not addressed this issue. North Carolina law permits such claims, but not “where the purported misrepresentation was made solely to a third party.” Id. (citations omitted). “Because . . . neither Plaintiff nor Plaintiff’s mother relied on any representation” from the defendant in deciding whether to use the drug, “Plaintiff’s fraud claim must fail under North Carolina law.” Id.

The parties agreed that, where a true conflict of law existed, North Carolina law would apply, as that state, where the Plaintiff ingested the drug and developed gynecomastia, had a greater interest in the application of its law than did Pennsylvania, the forum state. “Ultimately,” the court held,

[I]t is immaterial whether Pennsylvania law permits a fraud claim in pharmaceutical cases. Assuming, arguendo, that Pennsylvania permits [such a claim], then Pennsylvania law conflicts with North Carolina law and North Carolina law would apply. Conversely, if Pennsylvania law prohibits such a claim, then Pennsylvania law applies. In either scenario, Plaintiff’s fraud claims would be dismissed.

Id. at *19.

We love a good summary judgment decision.  P.D. is sound and well-supported, and we trust that it will be affirmed on appeal. We will keep you posted. In the meantime, the [very cool] eclipse has come and gone. In the words of the Fifth Dimension, “let the sun shine!”

 

We are beginning to feel like the Drug and Device Law theatre critic. Or perhaps we should say “theatre cheerleader,” as we rarely wax critical (at least about the stuff we include in our blog posts).  Last week, we saw the wonderful new musical Come From Away.   It is a true story, and it begins in the tiny town of Gander, Newfoundland on September 11, 2001.  On that infamous day, Gander opened its doors, and its collective heart, to many thousands of U.S.A.-bound airline passengers whose planes were forced to land when U.S. airspace was closed in the wake of the 9-11 attacks.  Despite the tragedy in the background – and in the foreground for some characters unable to confirm whether relatives were victims of the attacks – the play is an exquisitely energetic and joyful celebration of the openness of the human heart and the resilience of the human spirit.  On the last note of the last song, the cheering audience rose in unison in a manner we have rarely seen.

As in Come From Away, tragic facts are common in our line of work, but they can sometimes provide the framework for a silver lining. In the hands of a rigorous judge committed to correct application of the law despite the pull of sympathy, difficult facts can produce laudable precedent.   Such is not the case in today’s decision out of the Depakote litigation in the Southern District of Illinois.

In E.R.G. v. Abbott Laboratories, Inc., 2017 WL 3055520 (S.D. Ill. July 19, 2017), the plaintiff was a child who was conceived while his mother was taking Depakote and who was born with spina bifida and other birth defects.  At trial, the jury found for the plaintiff on his claim of negligent failure to warn and awarded fifteen million dollars in compensatory damages.  (The jury found that the evidence did not support an award of punitive damages.)  The defendant filed a post-verdict motion for judgment as a matter of law, arguing that: 1) the plaintiff did not produce evidence that the defendant failed to provide adequate warnings of the risk of spina bifida; 2) the plaintiff did not produce evidence that the defendant failed to provide adequate warnings of other birth defects; and 3) the plaintiff failed to prove warnings causation because no doctor testified that a stronger warning would have altered his prescribing decision.  In the alternative, the defendant moved for a new trial, citing evidentiary issues and improper comments during closing argument.

  1.  Motion for Judgment as a Matter of Law

                        Adequacy of Label Warnings

The defendant argued that the label warnings were adequate as a matter of law because the label contained a black-boxed warning of the (correct) 1-2% incidence of spina bifida when the drug was taken during pregnancy. This portion of the decision – like much of the rest – is confusing, but the judge seems to say that, notwithstanding the accurate spina bifida warning, it might have been the case that other portions of the label were inadequate and that the plaintiff’s mother might be saying that other proper warnings would have resulted in a decision to stop taking the drug when she was pregnant.  It’s not clear where the judge is getting any of this, because none of this hypothetical testimony is cited in the decision.  The judge also states that the plaintiff did not “concede” that the spina bifida warning was adequate.  Instead, according to the judge, the jury could adopt the plaintiff’s expert’s theory that the spina bifida labeling was not adequate because it did not state that the drug should be used by pregnant women “only as a last resort.”  In an opinion rife with wrong, we found this “last resort” argument to be the furthest from the mark.  We know of nothing in law or regulation that invites a judge to deem that only specific semantics would have rendered a warning adequate, when the label warned of the precise risk that befell the plaintiff and included an accurate statement of the incidence of that risk.

Finally, the judge held that the jury could reasonably infer that the label was “materially misleading” when it stated that all antiepileptic drugs carried a risk of birth defects, based on evidence that the defendant’s drug carried a higher risk of spina bifida than other drugs in the class. As such, the judge held, the jury could conclude that the defendant “watered down” the spina bifida risk when it lumped the drug in with others that carried a “much lower risk of spina bifida.” E.R.G., 2017 WL 3055520 at *3.  The judge concluded, “Ultimately, there was more than enough evidence presented in Plaintiff’s case in chief to support an argument that the label, including the spina bifida waning was inadequate.” Id. 

            Warnings Causation 

Because the plaintiff’s mother’s physicians testified that they were aware of Depakote’s teratogenic effects when they prescribed the drug, the defendant argued that the plaintiff had not established that any inadequacy of the drug’s warnings was a proximate cause of the plaintiff’s injuries. The plaintiff countered that the issue was not whether the defendant “failed to warn generally of ‘teratogenic effects’” but whether the defendant “provided full, accurate, and complete information about Depakote’s total teratogenic risks and instructions on the safe use of Depakote in women of childbearing age . . . .” Id. Forgive us, but we fail to see the distinction here.  One of the last two physicians to prescribe the drug before the plaintiff was conceived testified that he would have advised the plaintiff’s mother to stop taking the drug if he had been advised to use it as a “last resort” (the chosen language of the plaintiff’s expert and the judge), but he later testified that he would not have “taken away” the drug if the plaintiff’s mother had insisted on taking it.  The judge concluded, “. . . [A] reasonable jury could find that . . . a stronger warning would have caused [the last prescriber] (who was already on the fence about the efficacy of Depakote for [the plaintiff’s mother], to stop prescribing the drug.” Id. at *4.   We think this is a stretch, given the testimony.

The judge may have thought so, too, because she made a confusing attempt to justify her conclusion.   She postulated, “If the jury believed that [the doctor] would have discontinued [plaintiff’s mother’s] prescription in favor of a different [drug], then the jury could reasonably infer that she would still have been off of Depakote when she went to see [the other doctor] for her final visit” to the doctors’ clinic. Id. “Nothing in the testimony of [the second doctor] indicates that if [the plaintiff’s mother] had shown up for her appointment on [a different drug], he would have independently restarted the Depakote prescription.  [The second doctor] that, while he did make an independent assessment of [the plaintiff’s mother] at her last visit, he repeatedly asserted that he was ‘refilling’ her medication.” Id. (citation omitted).   Have trouble following that?  Can’t figure out what it has to do with warnings causation?  Neither can we.  Bottom line is that the prescribers knew that the drug could cause spina bifida and prescribed it anyway.  And, even if the imaginary “last resort” language had been included, the doctor would not have taken the drug away from the plaintiff’s mother if she wanted to keep taking it.  We fail to see how any of this adds up to warnings causation, except in the mind of a judge who didn’t want to grant the defendant’s motion.

  1.  Motion for New Trial 

Predictably, the judge also denied the defendant’s motion for a new trial. Some highlights of that decision:

Mother’s Testimony

In this case, unlike what we are used to seeing in the prescription drug context, the patient – the plaintiff’s mother – was apparently warned about birth defects while the plaintiff alleged that the prescribers weren’t. This led to an upside-down trial in which plaintiff didn’t call his mother in his case in chief while the prescribers testified live.   When the defendant learned that plaintiff’s mother was not being called, it filed a motion to compel her to sit for a de bene esse deposition.  The judge denied the motion, and this denial was one of the bases of the defendant’s motion for a new trial.  The judge held that her denial of the defendant’s motion was proper because the defendant had not adequately explained why the mother’s fact deposition (which was not videotaped) “did not accurately capture her testimony.” Id. (This in spite of the fact that, in our experience, plaintiffs routinely win motions like these.)

“Top 3” Opinion 

The defendant challenged the admission of one of the plaintiff’s expert’s opinions that Depakote was one of the “top three” teratogenic drugs in the PDR, arguing that the opinion was not the product of a reliable methodology. The court disagreed, holding, “While a different expert may come to a different conclusion or may even use a different methodology to determine what the three worst drugs are in terms of teratology, that is not the test for excluding an opinion under Daubert.” Id. at *6.

Improper Comments in Plaintiff’s Closing Argument 

The defendant argued that prejudicial comments in the plaintiff’s closing argument entitled it to a new trial.   These included the comment that the defendant was “guilty as hell” (the judge had to explain to the jury that this was not a criminal trial), as well as comments suggesting that compensatory damages should be based on the defendant’s alleged “bad behavior” (the judge halted this line of argument after the defendant objected that it was an argument for punitive damages, not compensatories) and that the jury, through its award “had a chance to make a decision about the kind of world [it] wanted to live in.” Id. at *7 (citation omitted).  The judge, predictably, held that none of the comments was “overly prejudicial.” Id.  

And so the verdict was allowed to stand. While we reiterate that we were not always able to follow the judge’s reasoning, our takeaway was that she started with her desired result and worked backwards.   As for us, our next foray onto the Great White Way occurs next week, when we accede to a request from the Drug and Device Law Rock Climber that we accompany her to the production of 1984 currently playing at the Hudson Theatre.  This production is notable for the proliferation of audience members fainting and vomiting during the torture scene, so we suspect that cheerfulness may not permeate our description.  And we will have to find a case that makes us queasy so we can easily tie it in.  Based on today’s decision, we suspect this will not be too difficult.  We’ll keep you posted.

One of the wonders of parenthood is its ability to deliver interludes so sublime in their exquisite simplicity that they provoke smiles long after they end. Such was an evening last week when we journeyed to New York to celebrate the birthday of the Drug and Device Law Rock Climber, now a waxing college senior completing a summer internship at an insanely cool company in Lower Manhattan.  We were treated to a tour of the office and to the comments that colleagues and mentors reserve for interns’ mothers.  We had perfect saltimbocca at a beloved Italian bistro.  We saw Waitress (again – we love this show).  We stayed overnight on the Climber’s couch, joined at some point by a four-pound Chihuahua.  And we relished every moment with this child-now-adult.  We were awash in happiness for the entire train ride home.

We were also happy (yet another suspect segue) with the court’s evidentiary rulings in today’s case, but decidedly not with the case’s very sad facts—an all-too-frequent dichotomy in our line of work. Because we spend vast amounts of our professional time struggling to achieve the exclusion of plaintiffs’ causation experts, we are always pleased to read a Daubert opinion that layers tidy analytical segments to reach a satisfying conclusion that correctly applies the Rules of Evidence and controlling case law.

In Smith v. Terumo Cardiovascular Systems Corp., et al., 2017 U.S. Dist. LEXIS 108205 (D. Utah July 12, 2017), the plaintiff’s decedent underwent open-heart surgery in which a heart-lung machine was used to circulate oxygenated blood through the patient’s body while his heart was being repaired.  At some point during the surgery, the machine stopped working for approximately ten minutes.  The plaintiff’s decedent never left the hospital after the surgery.  Eleven months later, he suffered a heart attack and died.

The plaintiff sued the hospital and the heart-lung machine’s manufacturer, asserting the usual claims. She hired a cardiologist as her causation expert, and he opined that the malfunction of the heart-lung machine caused the decedent to suffer physical and mental deterioration and ultimately caused his heart attack and his death.  The defendants moved to exclude the expert’s testimony, arguing that: 1) his causation opinions were unhelpful and unreliable; 2) he was not qualified to opine on neurological injuries; and 3) he should not be allowed “to provide a narrative of events that can and should be provided by other witnesses and records.” Smith, 2017 U.S. Dist. LEXIS 108205 at *5 (citation omitted).

Explaining that , “to be helpful, [the expert’s] opinion . . . that the . . . surgery and related complications had any causal . . . relationship to Mr. Smith’s injuries and ultimate death must be based on a ‘valid scientific connection,’ the court held that that the expert’s own deposition testimony demonstrated that his opinion would not be helpful to a jury. To wit, in his deposition, the expert admitted that he could not testify with certainty that there was a connection “between the surgery, the ten-minute lack of flow, and the heart attack that caused” the decedent’s death. Id. at *10-11 (citations omitted).   Instead, he could only go as far as concluding that “the events that happened at the time of surgery simply made it more likely” that the decedent would die as the result of a heart attack, although the decedent’s own risk factors –hypertension, smoking, diabetes, family history – were generally considered to be “the main contributors” to the development of the plaque that narrowed the decedent’s arteries and caused his myocardial infarction.  As such, the expert concluded, “[While] I think that what happened . . . played a role in his having a heart attack and made it less likely that he would survive a heart attack, but I cannot say that it caused his heart attack.Id. at *11-12 (emphasis in original, citation omitted).

While this is refreshing (and uncommon) candor for a plaintiff’s expert, it is obviously not “helpful” to the establishment of causation. Moreover, the court held, even if the testimony had been helpful, it was not reliable, because the expert did not “provide a basis to conclude that the relationship [was] causal and not merely corollary,” leaving too large a gap between his premise and conclusion, and because he failed to account for obvious alternative explanations for the decedent’s death.   Id. at *15-16.

The expert also concluded, contrary to the results of the decedent’s autopsy, that the decedent had suffered an earlier heart attack, around the time of the surgery, before the one that ultimately killed him eleven months later. The court held that this opinion was also inadmissible because the expert’s diagnostic methods were not generally accepted.  As such, the court concluded, “To allow the jury to hear [the expert’s] opinion on this point would be to allow the jury to hear conclusions based on inferior diagnostic metrics.  This will not be permitted.” Id. at *20.

Next, the court addressed the expert’s opinion that the decedent “suffered an injury to the brain due to prolonged lack of oxygenated blood flow to the brain.” Id. at *20-21.  The court held that the expert lacked the “knowledge, skill, training, or education that would qualify him to diagnose neurologic injuries.” Id. at 21 (internal punctuation and citation omitted).  Moreover, the opinion lacked any scientific basis, as the autopsy revealed no sign of hypoxic encephalopathy.   The court concluded, “[The expert] is not being as careful as he would be in his regular professional work outside his paid litigation consulting.  A jury has no use for [this type of speculation], especially from someone whose expertise lies elsewhere.” Id. at *24.

The court did not exclude the expert’s entire report, permitting him to testify that the decedent’s heart was injured during his surgery and to indicate what he relied upon to form his opinions. It held, however, that the expert would not be permitted “to give a general narrative of Mr. Smith’s health before, during, and after the surgery.” Id.

We like this opinion. It draws the correct lines, and it does so in clear and logical fashion.  It also reinforces the oft-apparent conclusion that plaintiffs’ lawyers disserve their clients when they hire the wrong people, and pay them to say the wrong things, in their quests for big settlement paychecks.   We will continue to keep you posted on judges who properly bar the courtroom doors against such experts, and those who don’t.

We just got tickets to see “Wicked” again (we think this will be the fourth or fifth time). Since we first saw it (on Broadway in 2003, featuring Idina Menzel’s Tony-winning performance), we have loved this quirky and oh-so-creative imagining of the backstory of “the Witches of Oz” – Galinda (later, without the first “a,” the “Good Witch of the North”) and Elphaba, the viridescent lass who, in Baum’s classics, grew up to achieve infamy as the “Wicked Witch of the West” – beginning with their days as schoolgirls and reluctant roommates.  We are eternally charmed by the subtle scarecrow-Toto-Dorothy references woven throughout (we notice at least one new one every time we see the show) and we never tire of the score (“Defying Gravity,” “For Good”).  We also don’t think it puts too fine a point on it to appreciate the resonance of a character whose life is shaped by a childhood in which she never “fit” and to be gratified by her unlikely happy ending.

 

And in this manner (wait ‘til you see this tie-in), the lesson diverges from unhappy ending of the plaintiff’s expert metallurgist in today’s case, whose conclusions were excluded, in part, because they did not “fit” the facts of the case and the issues the expert had considered. In its (regrettably) unpublished and (not regrettably) short decision in Redd v. DePuy Orthopedics, Inc., 2017 WL 2859536 (8th Cir. June 6 2017), which features an appearance by our beloved “sham affidavit doctrine,” the United States Court of Appeals for the Eighth Circuit reviewed the Eastern District of Missouri’s decision excluding the plaintiff’s expert’s “defect” and “causation” testimony and granting summary judgment for the defendant.

 

In Redd, the plaintiff – five feet tall, 302 pounds, and taking immunosuppressant drugs – received a total hip replacement using the defendant’s artificial hip.  Four years later, the hip stem fractured.  When it was removed, “doctors learned that it had not properly grown into the bone at the top of [the plaintiff’s] hip,” 2017 WL 2859536 at *1.  Plaintiff’s doctors were aware of this risk, heightened by the plaintiff’s marked obesity and her medications.  The plaintiff was implanted with a second hip stem, which similarly fractured less than two years later.

 

The plaintiff filed suit, asserting the usual negligence, strict liability, and manufacturing defect claims. She retained her metallurgy expert to opine about the cause of the hip stems’ fractures.  The expert “had done research in fatigue fracture initiation in metal objects but not in metal objects implanted in the human body.  His analysis considered metallurgical factors but not any biomechanical factors (such as a hip stem’s failure to grow into the hip bone . . .).” Id. He also “did not review any records related to the manufacturing process . . . .” Id. He opined that the fracture of the plaintiff’s hip stem was caused by the improper “phase” of the metal along with the “grain size” of the metal alloy (metallurgical terms of art, we assume).  He “acknowledged that environmental factors could have also contributed to the failure of the hip implant, but said that any small variation in the biomechanical forces would have been secondary in nature to the hip stem’s . . . state” in causing the failure. Id. (internal punctuation omitted).

 

The defendant moved for exclusion of the expert’s testimony and for summary judgment. In response, the plaintiff submitted an affidavit in which the expert testified, for the first time, that the “phase” of the metal in the hip stem violated the defendant’s own specifications, and that “environmental factors would be secondary in the cause of the fracture when the material is inherently defective to begin with.” Id. (internal punctuation omitted).  The defendant moved to strike the affidavit on the grounds that it impermissibly supplemented or changed the expert’s opinion after the close of discovery.

 

Throw a little Daubert on this expert, and his opinions melt away.

 

The district court held that the expert, while qualified to testify about metallurgy, lacked a scientific or factual basis for his “manufacturing defect” or “causation” testimony. The court further found that the expert had failed to consider the issue of the forces that were exerted on the implant inside the plaintiff’s body.  Finally, the court granted the defendant’s motion to strike the expert’s affidavit, noting that statements in the affidavit contradicted the expert’s earlier testimony and “a party cannot change testimony,” by submitting an affidavit, “just to avoid summary judgment or a Daubert motion.” Id. at *2.  (This is the “sham affidavit doctrine,” which we have used with glee and success in our own appeals.)  With the expert’s “defect” and “causation” testimony excluded, the plaintiff could not meet her burden of proving those claims, and the court granted summary judgment for the defendant.

 

On appeal, the Eighth Circuit affirmed all of the district court’s holdings. First, it held that the expert’s affidavit, invoking, inter alia, manufacturing specifications he earlier testified that he had not been provided, “arguably crossed the line between clarifying prior testimony and changing prior testimony,” id. (citation omitted); thus, the district court had not abused its discretion in excluding the affidavit from consideration.  The court also rejected the plaintiff’s argument that the district court had erred when it required the expert to exclude biomechanical causes of the plaintiff’s fracture.  The court emphasized that, while “an expert need not rule out all possible causes of an injury, [he] nonetheless should adequately account for obvious alternative explanations.” Id. at *3 (internal punctuation and citation omitted).  In this case, the expert failed to consider the obvious alternative cause of the plaintiff’s fracture; namely “the failure of the hip stem to grow into [the plaintiff’s] hip bone and properly distribute her weight,” id, and gave no consideration to the biomechanical forces applied to the hip stem.  As such, the court concluded, the district court had acted within its discretion in excluding the expert’s testimony on causation and defect.

 

Short, tidy, and correct on all counts. Keep ‘em coming.  As for us, we are off to see the Wizard (again).