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We have an adorable, pigtailed, toddler grand-niece. We play a game with her that involves placing one building block on the table and asking her how many blocks there are.  She answers, “One.”  We take that block away and replace it with another.  Again, the answer is “one.”  Then we place both blocks on the table and ask, “How much is one plus one?”  As brilliant as she is beautiful, she answers, “Two!”   Simple, right?  But those of us who practice in the mass tort space are far too accustomed to reading opinions laying out the building blocks of an obvious holding then failing to conclude that one plus one equals two.

Not so the lovely opinion on which we report today. In Young v. Mentor Worldwide LLC, 2018 WL 2054591, — F. Supp. 3d — (E.D. Ark. May 1, 2018), the plaintiff was implanted with the defendant’s sub-urethral sling in 2003 to address her stress urinary incontinence.  In two subsequent surgeries, in 2006 and 2008, portions of the sling were removed.   In 2013, more than five years after the last revision surgery, the plaintiff filed suit, asserting all of the usual claims and alleging permanent injury from the defendant’s product.

Because Arkansas law, which governs the plaintiff’s claims, imposes a three-year statute of limitations on product liability lawsuits, the defendant moved for summary judgment, alleging that the plaintiff’s claims were time-barred. The court denied the motion, finding a question of fact as to when the plaintiff’s cause of action accrued under the applicable discovery rule.

Motion to Bifurcate Trial

Flash forward to the eve of trial. Arguing that resolution of the statute of limitations defense would require only a few witnesses and would likely take only two days, the defendant asked the court to bifurcate the proceedings in a novel manner, holding a preliminary trial on the statute of limitations and moving on to a full trial on the merits of the plaintiff’s claims only if necessary.  The plaintiff opposed the motion, arguing that resolution of the statute of limitations issue would require admission of evidence of the defendant’s alleged fraudulent concealment and that a single jury should resolve all of the issues at the same time.

The court disagreed, holding,

Regardless of whether the [plaintiff is] entitled to pursue a fraudulent concealment claim, [the defendant’s] statute of limitations defense is potentially dispositive, and preliminary trial will not consume the time and expense necessary for a trial on the merits.  The Court finds that a separate, initial trial on the statute of limitations question is especially warranted in this case, as it will promote judicial economy, avoid confusion of the issues, and prevent possible undue prejudice.

Young, 2018 WL 2054591 at *2.

Motions to Exclude Expert Testimony

The defendant also moved to exclude the testimony of two of the plaintiff’s experts, a biomedical engineer and a pathologist.

Biomedical Engineer

The biomedical engineer sought to testify about the mechanical structure of the defendant’s product “and to offer his opinion that the design and testing of [the product] was inadequate, that the product was defective for its intended use, and that [the defendant] failed to warn about the significant risk of complications and adverse events from the use of the product.” Id. at *3.  The defendant moved to exclude the expert’s testimony about the adequacy of the warnings, arguing that the expert was not qualified to offer such opinions.  The court agreed, holding, “The record is void of information indicating that [the expert’s] expertise in the area of biomedical engineering and product design qualifies him to opine as to the adequacy of warnings at issue or that his opinion on this ultimate issue of fact would be helpful to the jury.” Id.

The expert’s report also included statements to the effect that the defendant was “fully aware” of a high rate of complications associated with the product. The defendant moved to exclude these statements on the ground that they were inadmissible expressions of “corporate intent and legal conclusions.”  Again, the court agreed, holding, “The Court finds that a jury is capable of making its own determinations as to [the defendant’s] intent, motive, or state of mind, and that [the expert’s] opinion on these subjects does not meet the helpfulness criteria of Rule 702.” Id. (citation omitted).

Pathologist

The pathologist’s report stated that his general causation opinions were “based on his review of over 300 explanted mesh samples, which include[d] hernia meshes, pelvic organ prolapse meshes, and slings used to treat urinary incontinence.” Id. at *4.  He acknowledged that only ten of the 300 samples he examined were manufactured by the defendant, and those were samples he received from plaintiffs’ attorneys.

The defendant argued that the expert’s opinions about other types of mesh and other manufacturers’ products were irrelevant and unreliable. In deposition, the expert testified that “all of this background” was necessary to “interpret accurately case-specific material.”  The court disagreed, holding, “The Court finds that neither [the expert’s ] explanation nor [the plaintiff’s] arguments demonstrate that information about various types of polypropylene mesh products . . . is relevant in this case, which deals with a specific mesh product, used for a specific purpose.” Id. Further, the expert “admit[ted] that he [had] no knowledge as to how the mesh implants he has examined were selected, thus there is no assurance that they were randomly selected and no way of projecting the potential rate of error.” Id. The court concluded, “After careful review, the Court cannot find that [the expert’s] proposed opinion testimony is the product of reliable principles and methods, and [the defendant’s] motion to exclude will be granted.

We love this opinion – logical, correct, and elegant in its simplicity. We hope that others follow suit, and we will keep you posted.

We are back in the trenches today after spending a wonderful day in New York with our lifelong best friend, in yet another of the blissfully endless celebrations of the milestone birthday we marked in December. We saw “The Band’s Visit,” a new musical based on a 2007 movie about eight members of an Egyptian police orchestra stranded overnight in a remote Israeli town.  The band members accept a local resident’s invitation to bunk overnight in her café, setting the stage for lovely intersections of hearts, minds, and cultures.  It is short, sweet, and very satisfying.

As is today’s case, for those of us who defend prescription drug and device manufacturers. In Kwasniewski v. Sanofi-Aventis, LLC, 2018 WL 1567851 (D. Nev. Mar. 30, 2018), the plaintiffs alleged that the defendant’s prescription sleep medication caused their decedent to commit suicide.  The opinion includes the judge’s decisions on objections to several earlier rulings by the magistrate judge and her decision on the defendant’s motion to dismiss the plaintiffs’ design defect claims.

Objections to Magistrate’s Rulings

First, the plaintiffs objected to the magistrate’s refusal to stay discovery – and relieve the plaintiffs of their obligation to respond to the defendant’s pending discovery requests – while the defendant’s Motion to Dismiss was pending. The court agreed with the magistrate, emphasizing that “[t]he Federal Rules of Civil Procedure do not provide for automatic or blanket stays of discovery when a potentially dispositive motion is pending.” Kwasniewski, 2018 WL 1567851 at *2.

Second, the plaintiffs objected to the magistrate’s application of Nevada’s learned intermediary doctrine.   In a 30(b)(6) deposition notice, the plaintiffs included topics concerning “information about direct to consumer advertising.”  Because, under the learned intermediary doctrine, the defendant had a duty to warn only “medical experts, not consumers, about the dangers of [its prescription drug],” id. at *4, the magistrate ruled that deposition testimony about direct-to-consumer advertising was irrelevant.  As such, she limited the plaintiffs’ Rule 30(b)(6) deposition topics to the defendant’s “representations to the medical community.”  The plaintiffs argued that the magistrate had “effectively decided a dispositive motion” by applying the learned intermediary doctrine, and that the doctrine was an affirmative defense that had not yet been pled.  The court again affirmed the magistrate and barred the plaintiffs from discovering information  that the defendant had disseminated directly to consumers. We like this ruling and applaud the court’s adherence to the standard imposed by Fed. R. Civ. P. 26, requiring discovery to be “relevant to [a] party’s claim or defense and proportional to the needs of the case,” and its refusal to sanction a meaningless and abusive fishing expedition.

Defendant’s Motion to Dismiss

The defendant moved to dismiss the plaintiffs’ design defect claims sounding in both strict liability and negligence, arguing that “any claim that [the defendant] should have changed the formulation of [the product] or that the product should simply not have been marketed are preempted by Federal Law.” Id. at *5.  In their response, the plaintiffs conceded that they were “not arguing that that [the defendant] should have reformulated the drug – just simply that [the defendant] should have” included adequate warnings of the drugs alleged suicidality risk. Id. As such, the court was able to grant the defendant’s motion, and foreclose the plaintiff’s from alleging a design defect claim at a later date, without addressing the preemption argument.. (Given this court’s clear-headed, correct-leaning rulings, we suspect that its preemption decision would have been fun to read.)

Kwasniewski is a tidy, no-nonsense, defense-friendly opinion.. If, on this beautiful spring day, we are confined to an office and not roaming the Great White Way, we are pleased that this case crossed our desk.

This morning, our commuter train was packed with overjoyed Villanova students headed for the NCAA Championship Victory Parade.   It was the second time in a few months that our fair city has been lifted by a huge sports triumph.  And, though our heads were ringing by the time we reached our stop (“Indoor Voice” is apparently not a course offered at Villanova), we love the infectious joy of these victories.

We also love a good Daubert victory, like today’s decision.  In Tsao v. Ferring Pharms., Inc., 2018 U.S. Dist. LEXIS 49173 (S.D. Tex. Mar. 26, 2018), the defendant manufactured a drug designed to stimulate women’s ovaries to produce eggs to be used for in vitro fertilization (“IVF”).  The plaintiff, an oncologist, underwent fertility treatments using the defendant’s drug.  Alleging that she purchased “defective, adulterated, and misbranded” vials of the drug, she sued the defendant for economic damages for breaches of express and implied warranties and violations of the Texas Deceptive Trade Practices Act.   The defendant had earlier voluntarily recalled certain lots of the drug because routine stability testing indicated that the lots “did not meet potency specifications and were out of specification . . . at the time of testing (twelve months or more into their shelf life.” Tsao, 2018 U.S. Dist. LEXIS 49173 at *1.   The plaintiff “complain[ed] that [the defendant] failed to inform her that [the drug] lacked the potency described in the drug’s Prescribing Information” and that she would not have purchased and used [the drug] had she known it did not meet those product specifications.” Id. at *3.  Claiming that the reduced potency adversely affected her fertility treatments, she sought recovery of money she spent to purchase the drug, money she spent on other medications used in conjunction with the drug, and the costs of her IVF treatments.

Among her designated experts, the plaintiff designated herself to offer a number of opinions, among them opinions related to the alleged “sub-potency” of the drug she purchased, the likelihood that this “sub-potency” would cause her IVF treatments to fail, and multiple issues related to ovarian stimulation, including the “usual” period of stimulation, the “prolonged” period necessary because the drug was “sub-potent,” and the supposed negative effects of this “prolonged stimulation.”  The plaintiff also designated a regulatory expert to testify about causation as well as the defendant’s “alleged lack of compliance with FDA regulations regarding drug recall and misbranded or adulterated drugs.” Id. at *11.  The defendant moved to exclude the plaintiff’s “expert” testimony and the testimony of her regulatory expert.

Motion to Exclude the Plaintiff’s Expert Testimony

The defendant moved to strike the plaintiff’s expert testimony on the grounds that: 1) she was not qualified as a reproductive endocrinologist; and 2) her opinions lacked the indicia of reliability required for medical expert testimony.  The court resoundingly agreed.  First, the court held that the plaintiff had “failed to demonstrate knowledge, skill, experience, training, or education with respect to reproductive endocrinology and drug recalls . . . .” Id. at  *17.   To wit, the plaintiff testified in deposition that “many of her opinions regarding [the drug] and reproductive endocrinology [were] based on internet research that she conducted using Google  and Wikipedia” as well as “the websites of different fertility clinics and online patient forums to research the average stimulation period” for women undergoing this type of therapy. Id. at *17-18.   In addition, the plaintiff testified that her opinions about issues related to the drug’s recall were “based on her general understanding of ow pharmaceutical companies work. Id. at  *19 (internal punctuation omitted).   And so, the court found, the plaintiff had not met her burden to demonstrate that she was qualified to offer her expert opinions.

Because it had excluded the plaintiff’s opinions based on her lack of qualifications, the court emphasized that it didn’t need to reach issues related to the reliability of her opinions. But it stated for the record that the plaintiff’s own opinion that she would have produced more eggs if the drug were “fully potent” was not reliable because: 1) it “did not “fit” with the scientific literature, the data contained in the medical record, or her treating physicians’ testimony,” id. at *21; 2) was not the product of the same rigor the plaintiff would use in her own practice (the court commented that it “[didn’t]  believe that [the plaintiff ] would base her opinions regarding treatment of an oncology patient on Wikipedia research”); id. at *24-25; and 3) her repeated deference to her treating physicians confirmed her lack of expertise in reproductive endocrinology. Id. at *26.

And so, while the plaintiff was obviously permitted to testify about her own experience, she was not permitted to offer her own “expert” opinions.

Motion to Exclude Regulatory Expert

The defendant challenged the testimony of the plaintiff’s designated regulatory expert on three topics: 1) the potency of the drug purchased and used by the plaintiff; 2) FDA labeling requirements; and 3) the recall of the drug.  After recounting the expert’s qualifications at length, the court held that she was generally qualified to testify as an expert, and, specifically, was qualified to testify about FDA regulations and recalls.  But the court held that the expert’s opinions that the drug was “misbranded” and “adulterated” were impermissible legal conclusions and were contrary to FDA regulations.  Specifically, the FDA had set a potency range within which the drug was required to fall – 80%  to 125% of the labeled potency —  and the drug was not “misbranded”  or “adulterated” or “out of specification,” according to FDA regulations, as long as it fell within this  range.  And there was no evidence that any lots of the drug that the plaintiff used were “out of specification” at the time she used them.  As such, the expert’s opinion that certain vials of the drug “may have” fallen out of specification by the time the plaintiff used them was “speculative, contrary to the evidence, and inadmissible ipse dixit.” Id. at *37.   Finally, the court held that the expert’s opinion that the drug’s potency was a key factor affecting the quality of retrieved eggs was unreliable because it was “contrary to the labeled indications for [the drug], her own deposition testimony, and the testimony of Plaintiff’s treating physicians.” Id. at *43.

Regular readers are familiar with our frustration with the too-frequent admission of expert testimony that should never see the light of day.   While many of the challenges to the Tsao opinions were, dare we say, a slam-dunk, it’s still nice to see an opinion come out the right way.  Let’s hope for more, and, on the day of the Phillies’ 5-0 victory in their home opener, hope springs eternal that they can harness some of the city’s “sports karma” for the long upcoming season.

We write this as key elements of the Drug and Device Law Passover Feast languish in the oven. Tomorrow, the Drug and Device Law Bubbie will force four generations of our family – the devout and the not and everyone in between – to read (aloud) the lengthy prayer service that precedes the meal.  The ritual includes much laughter, enthusiastic (if discordant) singing, and predicable misbehavior from those of us at the “kids’ table” (the 50- and 60-year-olds, as distinguished from our parents) that provokes sharp rebukes from the elders.  And, these days, the gathering is a little bit bittersweet (cue “Sunrise, Sunset”), as time’s toll on the eldest members of the clan is softened by the presence, each year, of more of our babies’ babies.  We complain about the cooking.  We grouse about the most troublesome relatives.  But we wouldn’t miss it for the world, though we should mention that “feast” is something of a misnomer, as many Passover staples are notorious for barely crossing the line into “palatable.”

Speaking of misnomers, earlier this week, one of our co-bloggers termed causation the “MVP” of mass tort practice. While we heartily agree in principle, we have read (and participated in) too many scenarios in which a passive judge “benched” this “player” to allow meritless cases to queue up in settlement inventories. On the flip side, we are heartened by the increase in Lone Pine orders demanding early causation evidence and by judges who refuse to allow plaintiffs lacking proof of causation to escape summary judgment.

Such was the result of today’s case, a Risperdal case out of the Northern District of Alabama. In Drake v. Ortho-McNeil-Janssen Pharms., 2018 U.S. Dist. LEXIS 47164 (N.D. Ala. Mar. 22, 2018), the plaintiff was an obese 36-year-old man who was diagnosed as schizophrenic at age 17.  He was initially prescribed Risperdal but was switched to other drugs several months later.   He was switched back to Risperdal about two years after that and then remained on the drug for about thirteen years before different drugs were again substituted.

Shortly after the plaintiff stopped taking Risperdal, a social worker noticed that he had large breasts and told his mother that he should be tested for gynecomastia, benign enlargement of glandular breast tissue in males. Antipsychotic medications have been associated with gynecomastia, which “is distinct from pseudo-gynecomastia, which is breast enlargement due to fat deposits in overweight males.  The two conditions may be differentiated only with a physical exam.” Drake, 2018 U.S. Dist. LEXIS 47164 at *4.  No exam took place.  The plaintiff was never diagnosed with gynecomastia, though his levels of prolactin were elevated.  Prolactin is a hormone that induces lactation, but it “does not have a direct grown-stimulating effect on the breast glandular tissue.” Id. at *6 (citation omitted).  Many of the drugs prescribed to the plaintiff were known to cause prolactin elevation.

The plaintiff’s complaint, asserting all of the usual causes of action, alleged that Risperdal caused him to develop gynecomastia. The defendant moved for summary judgement, arguing that the plaintiff could not meet his burden of establishing causation.  The judge emphasized that the plaintiff was required to prove both general and specific causation and that expert testimony was required for both.  The plaintiff’s expert was a certain former FDA commissioner who has testified that the risk of gynecomastia in children and adolescents was higher than Risperdal’s labeling represented.  But, as the court pointed out, while the expert’s “report and deposition testimony from other  cases might be sufficient to raise a question of fact regarding general causation, . . . his report and testimony contain[ed] no evidence regarding the cause of [the plaintiff’s] alleged injuries. Id. at *13.  And the plaintiff had no other causation expert.

As such, as the court put it, “the plaintiff’s evidence concerning specific causation [was] threadbare.” Id.  There was no evidence that the plaintiff had even been diagnosed with gynecomastia.  And while the plaintiff argued that, if his elevated prolactin level had caused “testosterone level drops leading to estrogen expression,” then Risperdal could “theoretically [have caused] gynecomastia,” there was “no evidence in the record regarding [the plaintiff’s] testosterone or estrogen levels, and evidence that Risperdal could theoretically cause gynecomastia [was] not sufficient to raise a disputed issue of material fact concerning specific causation.” Id. The court concluded, “In the absence of medical or expert evidence, a fact finder must speculate about the cause of [the plaintiff’s] enlarged breasts, and a verdict may not rest on speculation.” Id.  

In other words, maybes on top of maybes do not proof of causation make. If the plaintiff cannot be bothered to get a diagnosis or an expert, that plaintiff should not be in court.  Unassailable, although we’ve all seen too many such “easy” decisions go wrong.  We like this case.  We will continue to keep you posted on the good and the bad, and we wish happy gatherings to all celebrating any holiday this week.

Here in Philadelphia, less than a week before the first day of Spring, it is sunny and calm, albeit a bit chilly. Not so last week, when we were hit with the second Nor’easter in less than a week.  As much as sixteen inches of snow fell in some suburbs, and thousands of people, some of whom had just regained electric power after the last storm, were knocked into the dark and cold when tree limbs felled by heavy snow took power lines with them.  For the second time in as many storms, we found ourselves in a pocket on the low end of predicted accumulations.  We only got about six inches of snow, and it started melting quickly when temperatures rose in the evening.  And, again, our end of the street did not lose power.  (Assuming cooperation from the technology gods, this no longer affects us, as we happily parted with some retirement savings a few years ago in favor of a whole-house generator, after a four-day outage during which we tested long-held friendships by descending with the Drug and Device Law Menagerie in tow.)  The only “blip” was a scary near-miss.  We were out walking the Drug and Device Law Little Rescue Dogs at the height of the storm when a huge tree limb crashed down on a spot where we had stood ten seconds earlier.  Reminds us not to sweat the small stuff – this could have been tragic.

But save for that significant footnote, it was all pretty good.   And our assessment of today’s decision is similar.  In In re Bard IVC Filters Prods. Liab. Litig., 2018 WL 1109554 (D. Ariz. Mar. 1, 2018), the court ruled on a number of motions in limine in advance of a mid-March trial.  The plaintiff alleged that she was injured when defendant’s filter, inserted in her inferior vena cava (“IVC”) to capture blood clots, migrated and fractured.  The filter that was implanted in the plaintiff, a Class II device, was granted 510(k) clearance by the FDA because of its “substantial equivalence” to an earlier filter model the defendant had marketed.  And that is the source of the most interesting rulings.

Defendants’ Motion to Exclude Evidence of Complications Associated with Predicate Device

Earlier, the plaintiff had moved to exclude evidence of the 510(k) clearance process, a motion that the defendants “vigorously opposed.” In re Bard IVC Filters, 2018 WL 1109554 at *1.  The court agreed with the defendants, “noting that 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.” Id. (internal punctuation and citations omitted).  As such, compliance with the 510(K) clearance process was “certainly probative under Georgia law on the issues of reasonableness of the design, manufacture, and warnings of the [cleared filter]” as well as issues related to the plaintiff’s punitive damages claim. Id. Georgia law, hmmmm…. The Fourth Circuit’s Cisson misstep, going 180° the other way, was also Georgia law, as we discussed here.  Needless to say, we like this one better.

But having fought for admission of evidence of the 510(k) clearance process, the defendants were faced with the plaintiff’s intention to introduce evidence of complications with the predicate device. The defendant moved to exclude this evidence, arguing that the complications were not “substantially similar” to the issues the plaintiff experienced with her device.  The defendant argued that, ‘[b]ased on clinical experience with the [predicate] filter, [it] made several significant changes to the [new] filter.” Id. Because the plaintiff received the new filter, which had been “changed significantly” from the predicate device, the defendants argued that problems with the predicate device  had no relevance to the plaintiff’s case.

The court denied the motion, noting that the defendant had “avowed to the FDA that the design, material, components, fundamental technology, . . . and intended use featured with the [new filter] are substantially equivalent to those featured with the predecessor [filter].” Id. The defendants further asserted that “one of [the] goals in developing the [new] filter was to reduce the number of incidents of filter fracture and migration that [it] had observed with the [predecessor].” Id. The court concluded, “Given these facts, . . . [the defendant’s] knowledge of problems with the [predecessor filter] is relevant to central issues in this case” – whether the defendant properly designed the new filter to correct the problems, whether it failed to properly warn about the problems, and whether its conduct justified an award of punitive damages. Id. at *2.

This ruling presents a quandary. We have spent many years defending manufacturers of Class 2 medical devices and advocating for admission of evidence of 510(k) clearance. We can appreciate the tension and the difficulty of drawing appropriate evidentiary lines.  But evidentiary lines and regulatory requirements are different.  This is a variant of the same fallacy underlying the 510(k) admissibility point discussed above.  FDA regulatory requirements and admission of evidence in civil litigation are two different things, created for different purposes, and often don’t mix well.

That is true here. For one thing, there is more to 510(k) than just substantial equivalence (“SE”).  The entire relevant part of the FDCA allows for an SE finding where the device being considered:

(ii)(I) has different technological characteristics and the information submitted that the device is substantially equivalent to the predicate device contains information, including appropriate clinical or scientific data if deemed necessary by [FDA] that demonstrates that the device is as safe and effective as a legally marketed device, and (II) does not raise different questions of safety and effectiveness than the predicate device.

FDCA §513(i)(1)(A) (emphasis added), So a substantial equivalence finding by the FDA does not mean that the predicate device is technologically the same – or necessarily even close – as long as it “does not different questions of safety and effectiveness.”  That’s a lot different from the “substantially similar” standard generally used for admission of other occurrence evidence.

Admission of evidence of 510(k) clearance should not automatically open the floodgates to evidence of problems a plaintiff didn’t’ experience with a device she didn’t receive. The other occurrence could well arise from a “different technological characteristic.”  That would require a deeper dive into the regulatory pedigree of the device than occurred here.  We are thinking about this issue for a future post. Meanwhile, here are some highlights of the court’s less complicated rulings:

Defendants’ Motion to Exclude FDA Warning Letter

The defendants moved to exclude an FDA warning letter because: 1) it was an “informal advisory statement” by FDA; 2) it was issued more than seven years after the plaintiff received her IVC filter; and 3) the specific topics in it were not related to the filter the plaintiff received or to any issue in the case. Id. at *3.  The plaintiff countered that the letter was evidence to counter the defendant’s assertion that the FDA had never expressed concern about the defendant’s filters or taken any action against the defendant.   The court held that several sections of the warning letter lacked probative value because they addressed topics that were not at issue in the litigation.   Others addressed a generation of filter that was developed after the filter the plaintiff received.  The court granted the motion in limine with respect to those topics, but reserved for trial the question of the admissibility of topics related to the defendant’s handling and reporting of filter failures.  The court did conclude that, if the letter should become relevant at trial, it would be admissible under the public records exception to the hearsay rule.  Whatever happens later, the defendant’s first point about warning letters being “informal” and “advisory” was spot on.  We examined that issue in great detail here and here.

Plaintiffs’ Motion to Exclude References to IVC Filters as “Lifesaving” Devices.

The plaintiff sought to preclude the defendants from “putting on a ‘filters save lives’ defense” or from describing the filters as “lifesaving” or “life-extending.” Id. at *4.  The court denied the motion, holding that, under Georgia’s risk-utility analysis, “evidence concerning the benefits of IVC filters is directly relevant. . . .”

Plaintiffs’ Motion to Exclude “Standard of Care” Evidence

The plaintiffs sought to exclude the defendants from presenting evidence that IVC filters are “within the standard of care for medical treatment of pulmonary embolisms.” Id. at 5 (citations omitted).   The court denied the motion, agreeing with the defendants that “evidence regarding the use and benefits of IVC filters, and when they are called for, will be relevant to the jury’s risk-utility analysis, as well as evaluation of the failure to warn claims and [the surgeon’s] decision to implant” the defendant’s filter in the plaintiff. Id. In response to the plaintiffs’ concern that the jury could be confused about the standard of care to apply, the court conceded that “the standard of care for . . . design and marketing of IVC filters is entirely different from the medical standard of care for when filters should be used to treat patients.” Id. As such, the court held, the parties should refer to the “medical standard of care” when referring to the standard for implanting the filters, and should seek a clarifying instruction if warranted.

Plaintiffs’ Motions: “Nonparty at Fault” and “Intervening Cause”

Under Georgia law, a defendant may identify a “non-party at fault” and present evidence of that party’s fault to the jury. The jury may then include the non-party in its apportionment of fault and damages.  In this case, the defendant identified a diagnostic radiologist as the only “nonparty at fault,” alleging that the radiologist’s failure to report the condition of the filter to the plaintiff’s physicians was a cause of the plaintiff’s injuries.  While this was the only non-party whose fault the defendants intended to prove to the jury, the defendants argued that they should be permitted to introduce other doctors’ conduct, under a separate legal doctrine, as “intervening causes” of the plaintiff’s injuries, breaking the chain of causation between the defendant and the plaintiff and relieving the defendant of liability under Georgia law.  The plaintiffs moved to exclude evidence that  doctors not identified as “nonparties at fault” were “intervening causes” of the plaintiff’s injuries.  The court denied the motion, holding “. . . [A]lthough Defendants will be precluded from arguing that [other doctors] were negligent or at fault for purposes of apportioning liability, the Court cannot say that they should be precluded from asserting the fault of these nonparties as an intervening cause” of the plaintiff’s injuries.  The court emphasized that it would be careful to instruct the jury about the distinction between the two doctrines.

Plaintiffs’ Motion to Exclude Statements from Professional Associations

The plaintiffs sought to exclude evidence of statements of professional associations, trade groups, societies of physicians, and the like, arguing that the statements were hearsay, and, introduced through non-experts, would “evade Daubert scrutiny and would violate Rule 403.”  The court reserved its rulings for trial, holding that it could not grant the motion because the plaintiffs did not identify particular statements.  But it held that, on the present record, it could not conclude that the probative value of certain statements was outweighed by the potential for prejudice or that testimony about the absence of certain statements constituted inadmissible hearsay.  We see an analogy to how the federal rules treat learned treatises for hearsay purposes.

All in all, a pretty good day, with the exception of the quandary created by the rulings related to the admissibility of 510(k) evidence. That one isn’t as black and white as the ruling that was made.  We will keep you posted.

We recently read a news story about a man who was imprisoned for 39 years for a crime he did not commit. The crime was grisly and resulted in the violent deaths of a 24-year-old woman and a small child, leaving a community outraged and law enforcement officials determined to hold someone responsible.  So, burdens of proof be damned, the defendant was convicted despite the fact that relevant DNA recovered from the victims was not his.  Eventually, a crusading retired policeman succeeded in winning exoneration and freedom for the prisoner.   Now, we went to law school.  We know all about the differences between criminal law and civil law.  And we know we should be circumspect about fragile visceral analogies when we are well aware of the relevant distinctions.  Nevertheless, when we read a bad “innovator liability” decision – a decision holding an innovator drug manufacturer liable for injuries caused by a generic version of the drug – a drug manufactured by someone else – there is a simplistic part of us that fails to see how this is so different from imprisoning someone for a crime he did not commit

Today’s case, Garner v. Johnson & Johnson, et al., 2017 WL 6945335 (C.D. Ill. Sept. 06, 2017) (just surfacing though several months old), is just such a bad decision.  In Garner, the plaintiff alleged that a generic fluoroquinolone antibiotic caused her to suffer serious injuries.  She sued the generic drug manufacturer that actually made her drug along with the innovator drug company that manufactured the name-brand version of the drug.  The defendants moved to dismiss for failure to state a claim.

The court first considered the plaintiff’s claims against the generic drug manufacturer, and correctly concluded that, under Mensing, the claims, all rooted in alleged inadequacies of the generic drug’s warning label, were preempted.  But the court wanted to hold someone responsible.  So, noting that the Seventh Circuit had not yet addressed innovator liability, it undertook to circumvent Illinois law.

As we discussed in our “Innovator Liability at 100” post, Illinois has long required product identification for all product liability matters, as evinced by the Illinois Supreme Court’s rejection of industry-wide liability under both market share liability and public nuisance rubrics. See Young v. Bryco Arms, 821 N.E.2d 1078, 1087-91 (2004) (public nuisance); Smith v. Eli Lilly & Co., 560 N.E.2d 324, 337-39, 344-45 (Ill. 1990) (market share liability); City of Chicago v. American Cyanamid Co., 823 N.E.2d 126, 134-35 (Ill. App. 2005) (market share liability in public nuisance); Lewis v. Lead Industries Ass’n. Inc., 793 N.E.2d 869, 874-76 (2003) (same) (all four cases finding no causation as a matter of law without product identification). See also Leng v. Celotex Corp., 554 N.E.2d 468, 470-471 (Ill. App. 1990) (rejecting market share liability pre-Smith in asbestos case); York v. Lunkes, 545 N.E.2d 478, 480 (Ill. App. 1989) (rejecting market share liability pre-Smith in battery case); Poole v. Alpha Therapeutic Corp., 696 F. Supp. 351, 353 (N.D. Ill. 1988) (rejecting market share liability pre-Smith in blood products case); Coerper v. Dayton-Walther, 1986 WL 4111, at *1 (N.D. Ill. March 27, 1986) (rejecting market share liability pre-Smith in tire rim case).

Moreover, Illinois does not recognize a duty to warn about the risks of a competing product:

[Defendant] is under no duty to provide information on other products in the marketplace. Such a duty would require drug manufacturers to rely upon the representations made by competitor drug companies.  This arrangement would only lead to greater liability on behalf of drug manufacturers that were required to vouch for the efficacy of a competitor’s product.

Pluto v. Searle Laboratories, 690 N.E.2d 619, 621 (Ill. App. 1997).  Recently, an Illinois appellate court recognized in dictum that an “overwhelming majority of courts have held that generic consumers may not sue the brand-name manufacturer.” Guvenoz v. Target Corp., 30 N.E.3d 404, 409 n.1 (Ill. App. 2015). See id. at 416 (plaintiffs “cannot obtain relief from brand-name drug manufacturers whose products they did not ingest”).

But the Garner court disregarded all of this. The court acknowledged that, to state a claim for negligence, the plaintiff was required to establish that the defendants owed her a duty of care, and that the existence of such a duty turned on the reasonable foreseeability of the injury.  But it  held, “In the well-regulated pharmaceutical industry, . . . a brand-name manufacturer . . . is surely not blindsided to find out that the equivalent of its . . . [label] as imposed on generic versions of [its drug],” and that doctors and patients would rely on that label when prescribing and using the generic drug.   Garner, 2017 WL 6945335 at *7.  Further, the court held, it was “a common practice, and therefore foreseeable, for a doctor to prescribe a name brand drug and the pharmacy to fill it with the generic version.” Id. And so, though “other courts have expressed trepidation about the consequences of holding brand-name manufacturers liable for injury caused by generics,” id. (citations omitted), the court concluded that finding that the brand-name manufacturer had a duty of care to a plaintiff taking someone else’s drug “simply allows [the plaintiff] to attempt to recover from the one entity, under federal law, that has the unilateral ability to strengthen the label.” Id.  Even though that entity did not manufacture the product that allegedly injured her.

The court next addressed the issue of causation, acknowledging that “liability for negligence may not be imposed based merely on a breach of duty, without causation being established. Id. (citation omitted).  The plaintiff alleged that she would not have taken the generic drug if its label contained adequate warnings.  (Although the generic drug was a prescription drug, the court failed to analyze warnings causation from the perspective of the prescribing physician.) And the court held that “an extra link in the causal chain (here, the transfer of the identical label from the branded drug to the generic drug) does not break it.  It is possible for a plaintiff to show that injuries caused by mislabeling on a generic medication can be directly traced back to the brand name manufacturer’s creation of the label.” Id. (citations omitted).  As such, the court found that the plaintiff had “adequately alleged causation,” id., and, in derogation of its Erie duty to apply Illinois law, denied the innovator company’s motion to dismiss the plaintiff’s negligence claims.  Similar analysis allowed the plaintiff’s related claims to proceed.

We get the issue. We understand that the United States Supreme Court has limited the remedies of plaintiffs injured by generic drugs, even assuming they can prove a product defect, an injury, and causation in between.  But “someone’s gotta pay” cannot justify a decision that starts from a desired result and works backward, hurdling any doctrine or jurisprudence that gets in the way.  We defend innovator drug companies for a living, and we will continue to speak out against decisions like Garner. And we’ll keep you posted on what comes next.

With one glance at the calendar, regular readers of this blog will have been able to predict the content of these prefatory paragraphs, later to be (tenuously) tied to today’s case. On Monday and Tuesday, as we have for nearly twenty years, we attended the annual Westminster Kennel Club Dog Show, the second-oldest continuous sporting event in the United States (behind only the Kentucky Derby) in Manhattan.  The show draws the best representatives of almost 200 dog breeds, including two breeds eligible to compete this year for the first time: the Nederlandse Kooikerhondje and the Grand Basset Griffon Vendeen.  About 3,000 total entrants are narrowed, during daytime breed judging, to one “best of breed” winner from each breed, then (during the familiar nighttime televised portions) to seven group winners.

The climactic event is the selection of the best-in-show winner from the seven group winners.   (BTW, if you haven’t seen the movie Best in Show, we think it is one of the funniest movies ever made, and, like all good humor, it skates very close to a lot of truths.)  This year, unlike some years, none of the “breeds of our heart” was represented in the final seven, so we watched with excited anticipation but without a favorite.  Not so the sellout crowd.  A pug named Biggie, with a sad human interest backstory (google it), got roars, as did Flynn the Bichon Frise and the Giant Schnauzer that was the top-winning show dog in the country for 2017.  But the crowd favorite was a Sussex Spaniel (a cheerful-looking, low-slung, long-eared spaniel breed with a shiny golden-liver coat) named Bean.  Every time Bean got close to the “bait” – the treats his handler was carrying – he sat up on his haunches and begged.  Needless to say, the crowd swooned.  And we admit that this was insanely cute.  But Bean took it too far, doing his trick right under the judge’s nose, including when was supposed to “free stack” (get himself into a stretched, square stance without his handler placing his feet in the proper positions).

Ultimately, the beautiful little Bichon was Best in Show, and Bean’s begging was for naught, kind of like today’s case (we warned you), a terrific jurisdictional decision out of the consolidated Xarelto litigation in the Superior Court of Los Angeles County, California. In In re Xarelto Cases, 2018 WL 809633 (Cal. Super. Feb, 6, 2018), the plaintiffs sued several manufacturers and a distributor, claiming various injuries and alleging the usual litany of causes of action.  Appearing specially, the (non-resident) manufacturer defendants moved to quash service of the plaintiffs’ summons, arguing that California courts lacked jurisdiction over them.  In response, the plaintiffs served jurisdictional interrogatories and requests for production comprising 113 separate discovery requests, seeking information about marketing and clinical trials allegedly performed by the non-resident defendants in California, including free sample voucher programs, as well as information about the functions the resident distributor defendant performed for the non-resident manufacturers.  The defendants moved for a protective order, alleging that none of the pending jurisdictional discovery was permitted under the United States Supreme Court’s three recent jurisdiction decisions (Bauman, BMS, and BNSF Railway Co. v. Tyrrell, 127 S.Ct. 1549 (2017)), and the plaintiffs countered with a motion to compel responses to the outstanding discovery requests.

The court explained it weighed three factors in deciding whether to permit the jurisdictional discovery: 1) the nature of the jurisdictional facts the plaintiffs sought to discover; 2) whether sufficient methods of investigation were available to the plaintiffs without formal discovery; and 3) the likelihood that the plaintiff could establish the necessary facts. Xarelto, 2018 WL 809633 at *10.  It concluded, “. . . [T]he Court has weighed these factors, and finds that Plaintiff has not made a prima facie case for personal jurisdiction in order to conduct the requested jurisdictional discovery.” Id. (citation omitted).

First, under Bauman, because none of the manufacturer defendants was incorporated or had its principal place of business in California, the courts lacked general jurisdiction.  Second, with respect to specific jurisdiction, noting that the (non-resident) plaintiffs were allegedly injured in their home states, the court held that, under BMS, neither the fact that clinical trials were performed in California nor the fact that the manufacturers hired a resident distributor was sufficient to establish that the plaintiffs’ claims “arose out of” the defendants’ contacts with California.  As such, the court found, “the proposed discovery seeks information on, at best, merely tenuous contact between the Defendants and California.” Id. The court concluded, “Consistent with BMS . . . , the requested discovery will not likely lead to the production of facts establishing jurisdiction over the defendant, based on the allegations of the complaint.  Under these circumstances, the Defendants’ requested protective order is appropriate.” Id. at *11.  That’s right — not a single one of the 113 discovery requests was allowed.

We love this decision. Its correct application of the Supreme Court’s mandates underscores the demise of litigation tourism and emphasizes the futility of plaintiffs’ pervasive and reprehensible joinder of distributors in quest of jurisdiction.  We hope other courts follow suit.  And we’ll keep you posted.

This year’s Academy Award nominations came out last week. That means that we have spent the past few days setting a schedule for seeing all of the Best Picture nominees (well, most – we don’t do war movies and tend to opt out of love stories involving semi-animate objects) and scouring recipe blogs for perfect Oscar party buffet items.  We have also reminisced, with amusement, about the climactic moments of last year’s show, during which the presenters announced the wrong Best Picture winner before an Academy official shoved them out of the way and corrected the error.  As we recall, it turned out (not surprisingly) that the mistake was caused by sloppiness.  The Academy’s accountant handed the presenters a duplicate envelope for an award that had already been presented, starting the embarrassing domino cascade.  We recall that heads rolled in the ensuing days.

Today’s case also involves the consequences of sloppiness, along with a couple of interesting legal rulings. In its unpublished decision in Small v. Amgen, Inc., et al., 2018 WL 501354 (11th Cir. Jan 22, 2018), the Eleventh Circuit considered the plaintiff’s appeal of two summary judgment orders:  a grant of partial summary judgment for the defendants, and a later grant of summary judgment on all of the remaining claims.

The plaintiff was prescribed the defendants’ drug to treat her rheumatoid arthritis. She took the drug for nearly six years then suffered a perforated bowel and a diverticulitis infection, for which she underwent multiple surgeries.  She sued the drug’s manufacturers, asserting all of the usual claims. In 2014, the district court granted summary judgment on the plaintiff’s failure-to-warn claims, holding that Florida’s learned intermediary doctrine precluded the claims.  Later, when the plaintiff’s expert disclosures revealed her sloppy omissions — although she identified five treating physicians she intended to use as non-retained experts, she had no expert to testify to general or specific causation — the defendants moved for summary judgment on the plaintiff’s remaining claims.  In 2017, the district court granted the defendants’ motion.

On appeal, the plaintiff did not dispute or even address the 2017 summary judgment order. Instead, she argued that the 2014 dismissal of her warnings claims was improper because there were factual issues “regarding the district court’s treatment of [her prescriber] as a learned intermediary.” Small, 2018 WL 501354 at *2.  She also argued that “the district court incorrectly decided that the direct ‘patient labeling requirement’ in the FDA medication guidelines did not preempt Florida’s learned intermediary doctrine.” Id.

With respect to the prescriber-as-learned-intermediary argument, the court explained that the plaintiff’s prescribing physician had 22 years of experience in rheumatology and “intentionally selected [the drug] for [the plaintiff], despite the risk of possible infections, because other forms of rheumatoid arthritis therapy had failed.” Id. What’s more, the prescriber was involved in clinical trials with the drug, and the plaintiff was a participant, giving the prescriber “more reason to know of and discuss possible side-effects or concerns” associated with the drug.” Id. The prescriber “knew that infections were possible but prescribed the drug anyway . . . because the benefits outweighed the risks.” Id. As such, because “the prescribing physician had substantially the same knowledge as an adequate warning from the manufacturer should have communicated,” the plaintiff could not prove warnings causation and her warnings claims failed as a matter of law. Id. (internal punctuation and citation omitted).   In other words, “the failure of the manufacturer to provide the physician with an adequate warning . . . is not the proximate cause of a patient’s injury if the prescribing physician had independent knowledge of the risk that the adequate warning should have communicated.” Id. (citation omitted).

Next, the plaintiff argued that Florida’s learned intermediary doctrine was preempted by the FDA’s requirement that the manufacturers provide patients with a “medication guide” for the drug. The court emphasized that “the historic police powers of the State [were] not superseded unless that was the clear and manifest purpose of Congress.” Id. at *3 (internal punctuation and citation omitted).   To discern such “clear and manifest purpose” in cases of implied preemption, the court explained that it considered “the promulgating agency’s contemporaneous explanation of its objectives as well as the agency’s current views of the regulation’s preemptive effect.” Id. (internal punctuation and citation omitted).

In the case of the medication guide regulation, the FDA had specifically addressed concerns that the regulation would alter the framework for manufacturers’ liability by abrogating the learned intermediary doctrine.  In response, the agency stated that “the written patient medication information provided did not alter the duty, or set the standard of care for, manufacturers [or] physicians . . . .” Id. (citation omitted).   Given this “contemporaneous explanation” from the FDA, coupled with the reality that “courts have not recognized an exception to the learned intermediary defense in situations where the FDA has required patient labeling . . . ,” the court held that there was no preemption.  We love this holding, and we believe this is the first time that an appellate court has so held.

No preemption, no warnings causation – summary judgment on warnings claims affirmed. And, because the plaintiff did not address her inexplicable failure to identify causation experts, the court held that she had waived any appeal of the 2017 summary judgment order.   Case (tidily) dismissed, in a no-nonsense decision we like very much.  We’ll let you know if we are similarly pleased by this year’s Oscars.

Last week, we took a short Western Caribbean cruise to celebrate a jarringly-advanced birthday. While the weather wasn’t an asset (it was 43 degrees when we departed Fort Lauderdale, and hovered in the 60s for most of the trip), we left behind record cold and treacherous ice in Philadelphia, so we had no climatic complaints.  We were slightly apprehensive, however, because we were sailing on the very ship that had been in the news a few weeks earlier for a norovirus outbreak that sickened a couple hundred passengers.  But we convinced ourselves that the adverse publicity surrounding the recent outbreak would ensure that pre-sailing sanitation and onboard precautions were at an all-time high.  And we were correct:  the entrance to every venue on the ship was blocked by crew members bearing giant bottles of hand sanitizer, application of which was required for passage.  Even at the 24-hour soft-serve frozen yogurt machine (if we were assured this would be operational at all times, we could happily exist without dining rooms), the crew member manning the controls would not hand over a cone to anyone who did not sanitize first.  It apparently worked:  we came through unscathed and heard of no reports of illness on the ship.  (We also had a blast — played round after round of trivia, “clear kayaked” off the coast of Cozumel, drank many glasses of wine, and spent hours and hours motionless except for turning the pages of our book.)  Bottom line was that the cruise line did all that it was supposed to do to protect its passengers.  Beyond that, people had to be smart and careful, because the ship’s duty only extended so far.

Today’s case also involves questions of duty and of whether the defendant’s duty extended as far as the plaintiff said it did.   In Liu v. Janssen Research & Development, LLC, No. B269318, 2018 WL 272219 (Cal. Ct. App. Jan. 3, 2018), an unpublished decision from the California Court of Appeal, the plaintiff’s son and decedent died after briefly participating in a clinical trial for a long-acting injectable form of the defendant’s antipsychotic medication.  The decedent had begun treatment for mental illness nine years earlier, and had been taking another antipsychotic medication for five of those years.  His treating psychiatrist was the doctor selected to be the principal physician/investigator for the defendant’s clinical trial, and it was she who invited the decedent to participate in the study.

The decedent underwent a screening EKG, which revealed several abnormalities, and a blood test, which revealed slightly elevated liver enzymes. The treater concluded that the results were not clinically significant, and “based on [the decedent’s] otherwise normal physical examination and denial of a family history of cardiac disease,” she admitted him to the study. Liu, 2018 WL 272219 at *1.

Three days later, after a second blood test, the decedent was injected with a non-therapeutic one-milligram dose of the study drug to test for adverse reactions. A second EKG was performed within two hours.  The next day, the results of this EKG and the pre-injection blood test were analyzed, and they indicated worsened cardiac function and much higher liver enzymes than four days earlier.  The decedent was admitted to an acute-care hospital, where he was diagnosed with cardiomyopathy, pneumonia, failing liver function, and altered mental state.  He died two days later.

The plaintiff sued a host of study defendants, including the treater and the drug manufacturer, for negligence, product liability, and negligent failure to warn. After much motion practice, the case proceeded to trial on only the negligence claims and against only the drug manufacturer.  The defendant moved in limine to exclude the plaintiff’s cardiology and pharmacology experts’ opinions that the one-milligram test dose contributed to the decedent’s death, but the trial court admitted the testimony.

At the close of evidence, the trial judge granted a partial directed verdict, finding that the physician/investigator (the treater) was not the agent of the defendant for purposes of finding the defendant vicariously liable for her medical negligence. This left two issues for the jury to consider: 1) whether the defendant manufacturer had an independent duty to intervene in the decedent’s medical care, even if the medical issues “preexisted, or were unrelated to, the study itself,” id. at *5; and 2) the defendant’s duty to monitor the administration of the study drug, including the issue of whether the one-milligram test administration caused the decedent’s death.  The jury found that the defendant was negligent and that its negligence was a substantial factor in causing the decedent’s death, assessing the defendant’s fault at 70% and awarding $5.6 million in damages.

On appeal, the Court of Appeal considered whether the defendant had a duty to intervene in the decedent’s treatment for his preexisting heart disease, and whether there was sufficient evidence that the single one-milligram test dosage was a substantial factor in causing the decedent’s death. With respect to the first question, the court held, “We agree as a matter of law that defendant, as the drug manufacturer/sponsor of a clinical trial, undertook a general duty not to harm the study participants as part of the clinical trial protocols. Administration of the [test dose] fell within the scope of this duty, and we will discuss the sufficiency of the evidence to support liability under this duty of care . . . . But the significant legal question . . . is whether the general duty not to harm study participants encompassed a duty to diagnose or treat [the decedent’s] preexisting, life-threatening heart disease and to intervene in the medical care and decisions precipitated by [the decedent’s] abnormal test results.  . . . [W]e conclude that it did not.”  Id. at *6.

The court’s holding turned on the question of foreseeability. It explained that the general duty FDA regulations impose on study sponsors – to ensure compliance with study protocols and the participants’ safety – is intended to “protect participants generally from foreseeable harm caused by the drug studies themselves, including participants’ adverse reactions to study medications.” Id. at *7.   But it cited state law decisions standing for the proposition that “it is not foreseeable to a study sponsor that study physicians with the primary responsibility for participants’ health and safety will fail to recognize, diagnose, and properly treat preexisting, life-threatening conditions that first manifest during drug studies,” as did the decedent’s heart and other conditions. Id. (citations omitted).  Simply put, “it is not reasonably foreseeable to a drug study sponsor that the response by study physicians . . .  would fall below the standard of care for a medical practitioner.” Id. at *8.

That left the question of medical causation. As noted, the jury’s verdict was based on the testimony of the plaintiff’s cardiology and pharmacology experts. Both experts testified on direct examination that the test dose was a substantial factor in causing the decedent’s death.  But, while the pharmacologist testified that the drug could cause heart arrhythmias, she admitted that there was no evidence that the decedent died from an arrhythmia.  And, while the cardiologist “unequivocally concluded the administration of any amount of the test drug . . . was sufficient to push the decedent ‘over the edge,’ [he] did not provide a reasoned explanation that illuminated for the jury how or why such a low dose of [the drug] could have had such a substantial effect on [the decedent’s] life-threatening heart disease.” Id. As such,  the appeals court found that, “at best, [both] causation experts opined as to a theory that might have contributed to [the decedent’s] death, [they] did not provide the necessary factual basis to qualify that theory as substantial evidence.” Id. at *12.

Judgment for the plaintiff reversed. And though the decision is unpublished and can’t be cited, it reinforces the reality that duties are not unlimited and drug companies aren’t responsible for medical care and aren’t liable for everything that happens to everyone who takes their drugs.  We like this decision and wish it were published – we’ll keep our eyes open for one that is.  And now, we’d gladly use a gallon of hand sanitizer for one more stroll around the deck with a frozen yogurt cone.

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.