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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.

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.