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Summer can be a good time to catch up on tv shows we missed the first time around (e.g., Dead to Me, Luther series 5, and Catch-22). It can also be a good time to catch up on cases we somehow failed to flag when they came out earlier in the year. We won’t beat ourselves up too much for missing the excellent result in the soon-to-be-frozen north in In re Bair Hugger Forced Air Warming Devices Prods. Liab. Litig., 2019 WL 4394812 (D. Minn. July 31, 2019). After all, the opinion was filed under seal and became available only recently. We have, of course, covered many interesting developments in the Bair Hugger saga. (Bexis visited Iceland this Summer, so we are quick to spot the opportunity for sagas.) See Bair Hugger blogposts here and here, for example. This latest decision should sound the death knell for the Bair Hugger multi-district litigation.

About six weeks ago (before Bexis circumnavigated the land of geysers, trolls, and the famous 1972 Fischer-Spassky chess championship match), the defendants won summary judgment on all the claims in the Bair Hugger MDL in the District of Minnesota. The plaintiffs claimed that the Bair Hugger, a device for keeping surgical patients warm, had caused joint infections. This claim rested on the opinions of certain plaintiff experts, including at least one repeat player many of you will know. Those plaintiff experts, as per the usual terpsichore, offered general and specific causation opinions. Key to the victory this Summer was the defendants’ successful effort to convince Judge Ericksen to revisit her previous decision in December 2017 to admit plaintiffs’ general causation expert testimony. Those experts had offered “airflow disruption” and “dirty machine” theories, and the court’s Christmas gift to the plaintiffs last December was to hold that those theories passed muster.

Getting courts to reconsider opinions is not easy. How did it happen here? An intervening bellwether trial, with effective cross-examination of the plaintiff experts, showed the flaws in the experts’ opinions. The trial judge ended up quoting one of our favorite Posner lines (“the courtroom is not the place for scientific guesswork, even of the inspired sort. Law lags science; it does not lead it.”), and excluded the plaintiffs’ medical causation experts and fluid dynamics expert. Judge Eriksen also relied on, inter alia, the Mirena decision. She engaged in an insightful discussion of the difference between reconstructions of actual events and illustrations of general principles. The air flow modeling was rudimentary and failed to replicate relevant conditions accurately. Opinions based on unproven and untested computer modeling amounted to ipse dixit leaps over yawning analytical gaps. The plaintiff experts failed to account for the movement of people in operating rooms. The plaintiff expert opinions were also suspect because they were developed for use in litigation. It was improper for the plaintiffs’ experts to cite literature for conclusions that the articles’ authors did not reach. Moreover, the plaintiff experts failed to investigate and rule out obvious alternative causes. Nor was there general acceptance of plaintiffs’ expert’s causation theories.

Adios to both the “airflow disruption” and “dirty machine” theories of defect.

These, er, problems with the plaintiff expert opinions managed simultaneously to shock and bore us. This sort of biased, result-driven sloppiness is all too familiar to any defendant stuck in an MDL. Kudos to the Judge in the Bair Hugger MDL for ultimately doing the right thing.

The Daubert rulings meant that the plaintiffs could not raise a genuine material issue of fact regarding causation. That outcome, by itself, spelled doom for almost all of the plaintiffs’ claims. The plaintiffs tried to save their claims for unjust enrichment and consumer protection, arguing that those claims do not require proof of causation. But the court held that causation is implicitly required for unjust enrichment, otherwise how could the defendants have received a benefit under inequitable circumstances? Similarly, the consumer protection claims depend on a showing by the plaintiffs that they were injured by the defendants’ actions. “Because Plaintiffs lack reliable evidence that the Bair Hugger causes infection, Plaintiffs cannot establish that they suffered an injury as a result of Defendants’ actions.”

Keeping score – the defendants have now won summary judgment in both the federal MDL and the Minnesota state court “mini-MDL,” about which we have already blogged. Naturally, the Bair Hugger plaintiffs have appealed to the Eighth Circuit. On this record, with a district court judge who afforded the plaintiffs every opportunity to take their best shot, we expect and hope for a resounding affirmance.

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Today’s case doesn’t involve prescription drugs or medical devices.  But it is a circuit court opinion that we thought warranted bringing to the attention of our readers who deal with False Claims Act (“FCA”) claims.  We’ve discussed FCA claims as an “awkward vehicle” in pharmaceutical cases here and we hold true to that belief.  But, as we all know qui tam plaintiffs (relators) try to append the FCA to allegations of off-label promotion of prescription drugs.  The allegations typically go something like this – pharmaceutical company engaged in a nationwide “scheme” to promote its drug off-label, doctors therefore prescribed it off-label, and then the pharmacies filed claims with the government for those off-label prescriptions.  Putting aside that typically plaintiffs cannot sufficiently allege a connection between the alleged off-label promotion and any claim made to the government – where’s the “objective falsehood” that is the touchstone of an FCA claim.

Well, that was precisely the question before the Eleventh Circuit in United States v. Aseracare, Inc., — F.3d –, 2019 WL 4251875 (11th Cir. Sep. 9, 2019) in the context of claims for hospice care.  In order for a hospice claim to eligible for Medicare reimbursement, the attending physicians must certify based on the doctor’s “clinical judgment regarding the normal course of the individual’s illness” that the individual is terminally ill.  Id. at *2.  Terminally ill means that the patient’s life expectancy is 6 months or less.  Id.  That does not mean that if a patient survives for longer than 6 months, they are no longer eligible for hospice care under Medicare. The regulations take into consideration that “predicting life expectancy is not an exact science.”  Id. Patients can improve, they can be removed from hospice and return to hospice, they could simply survive longer than anticipated.  So there are also recertification periods every 60 to 90 days to remain on hospice.  There are not set criteria for determining whether a patient is terminally ill, but there are guidelines.  The bottom line is that the treating physicians are required to review all the medical information concerning the patient and user their best clinical judgment to reach a conclusion regarding whether a patient is terminally ill.  While the regulations may be different, the underlying premise is very similar to a physician using his/her clinical judgment to decide whether to prescribe a medication to a patient for an off-label purpose.

Plaintiffs in the present case alleged that defendant, a collection of hospice care providers, “submitted documentation that falsely represented that certain Medicare recipients were terminally ill when in the Government’s view they were not.”  Id.  at *3.  Again, sounds similar to a claim that prescriptions were falsely submitted for off-label uses that in the government’s view were not medically necessary.  The key words being “in the government’s view.”  The government was not alleging that the certifications by the treating physicians weren’t supported by the underlying medical records or by the physician’s own clinical judgment.  Just that the government didn’t agree with the treating doctor’s conclusion.

The case proceeded to trial because at the summary judgment stage, the trial court was unwilling to adopt a “reasonable doctor” standard.  Id. at *5.  At trial, the government’s expert testified that based on his review of the records, it was his medical opinion that the patients had life expectancies of greater than 6 months. The government’s expert conceded, however, that “his testimony was a reflection of only his own clinical judgment based on his after-the-fact review of the supporting documentation.”  Id. at *6.  Moreover, the government’s expert did not testify that no reasonable doctor would have concluded that the patients were terminally ill.  Id.

After a jury verdict in favor of plaintiff, on defendant’s post-trial motions, the court determined that it erred in not instructing the jury that proof of an “objective falsehood” was a necessary element of an FCA claim and that “a mere difference of opinion between physicians, without more, is not enough to show falsity.”  Id. at *8.  The Eleventh Circuit agreed.

The government’s primary argument against a narrow reading of what constitutes a falsity under the FCA was that hospice care would be eligible for reimbursement for anyone who finds a physician to sign the certification.  Id. at *13.  But that overlooked that the certification still had to be based on the physician’s clinical judgment informed by the patient’s medical records. Nothing in the court’s ruling required that every claim for hospice care had to be reimbursed without review by the government.  The government is still free to challenge any claim it believed was not “reasonable and necessary” under the regulations.  For instance, if the government had proof that the certifying doctor didn’t review the patient’s medical records or if the government proved that no reasonable doctor who have found the patient terminally ill. Id. at *15.    What it cannot do is use after the fact, secondary opinions to contradict first-hand, fully-informed, reasonable medical decisions by patient’s physicians.  Just as the regulations provide – life expectancy is a not an exact science.  So, it is not difficult to believe that two doctors could disagree – and neither be wrong.  Maybe because this is something we’ve lost sight of in general society, it warrants repeating.  Two people can hold different opinions and neither person is wrong.  It may be equally accurate to say neither person is correct either.  That’s why we call it an opinion.  It’s a person’s or people’s view or judgment.  We talk about opinions every single day on this blog.  They are the views of a single judge or a particular court as to what the law is.  Sometimes we don’t agree with them.  Sometimes we even accuse them of getting it wrong.  But that’s just our opinion too.

In medicine, a doctor renders an opinion about medical care.  It needs to be an informed opinion to be valid, but it’s still an opinion nonetheless. He/she needs to use his/her medical knowledge and the knowledge of his/her patient to reach a learned conclusion.  But it is still an opinion subject to individualized interpretation.  That’s why people get second opinions for major medical decisions.  But if your second opinion differs from your first, was your first doctor wrong or the second doctor?  In either event, neither was lying to you.  Neither stated an “objective falsehood.” That’s why the government didn’t have an FCA claim in this case.

[A] reasonable difference of opinion among physicians reviewing medical documentation ex post is not sufficient on its own to suggest that those judgments—or any claims based on them—are false under the FCA. A properly formed and sincerely held clinical judgment is not untrue even if a different physician later contends that the judgment is wrong.

Id.

We think this should apply to FCA claims involving allegedly medically unnecessary off-label uses.  There is no law against doctors prescribing drugs or using devices off-label if they are using their own independent medical judgment and doing what they believe to be in the best interests of their patients.  So, an FCA claim premised on off-label promotion supported by nothing more than plaintiff’s experts disagreeing ex post with the reasoned judgment of patients’ doctors shouldn’t hold up using the reasonable doctor standard adopted by the Eleventh Circuit.

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We were in western Tennessee last week for an argument.   We stayed at a beautiful and venerable hotel, most famous for twice-daily “march of the ducks.” Every morning, at 11 a.m. sharp (at least 30 minutes after guests have packed the lobby), an elevator door opens, and a uniformed “duck master” leads a perfect procession of mallard ducks down a red carpet to the lobby fountain, where the ducks climb steps and jump in.   There they spend the next six hours, splashing and snacking, ‘til, at 5 pm, with just as much ceremony, they march back to the elevator and are returned to their rooftop habitat.   They are rotated back to a duck farm after three months, where they live out their lives as wild ducks while new recruits take the next three-month shift at the hotel. It is altogether delightful, and the hotel capitalizes with “all things duck” – duck-shaped butter served with morning toast, duck-shaped soap at the sink, duck-shaped chocolates on the pillows. (And no duck served in any hotel restaurant!)  It all fits together perfectly.

Unlike today’s case, a duck out of water from both jurisdictional and substantive perspectives. In Jones v. Medtronic, Inc., 2019 U.S. Dist. LEXIS 137304 (D. Ariz. Aug. 14, 2019), the plaintiff underwent three spinal fusion surgeries using the defendants’ intervertebral body fusion devices, their spinal fixation system, and their Infuse bone graft material The plaintiffs’ spine failed to fuse. She filed suit, asserting the usual product liability claims and alleging that the defendants’ bone graft material was not supposed to be used with the particular fusion devices used in her surgeries but was designed only for use with another fusion device. She alleged that the fusion devices used in her surgeries were known to “migrate, subside, and [be] expulsed,” which prevented them from containing the bone graft material long enough for spinal fusion to occur.   Jones, 2019 U.S. Dist. LEXIS 137304 at *3. The defendants moved to dismiss the complaint pursuant to Rules 12(b)(2) (lack of personal jurisdiction) and 12(b)(6).

Motion to Dismiss for Lack of Personal Jurisdiction

In their 12(b)(2) motion, the three defendants argued that the plaintiff had not made a prima facie showing that the court had either general or specific personal jurisdiction over them. As an initial matter, the court found that one of the defendants had waived its objections to personal jurisdiction because it had not raised the issue when it filed a motion to dismiss an earlier version of the complaint. With respect to the remaining defendants, the court found that it did not have general personal jurisdiction because the defendants were not incorporated in Arizona and did not have their headquarters or principal places of business in Arizona. With respect to specific personal jurisdiction, the court explained that, under Bauman, the plaintiff was required to make a sufficient showing that the defendants purposefully directed their activities toward Arizona or “performed [acts] that resulted in it availing [themselves] of the laws of Arizona.” Id. at *10.   The court explained that the plaintiff had not adequately alleged that the defendants maintained manufacturing facilities in Arizona or that her claims arose out of or were related to the defendants’ forum-related activities.   The plaintiff’s fusion surgeries were not performed in Arizona, and the court emphasized that “the plaintiff’s status as a resident of Arizona is insufficient to confer personal jurisdiction” over the defendants. Id.  As such, the court held, it did not have personal jurisdiction over either defendant.   This left one defendant, and the court addressed the 12(b)(6) motion with respect to that defendant.

Motion to Dismiss for Failure to State a Claim

Manufacturing Defect: The plaintiff alleged that the fusion devices had a manufacturing defect because they “had a tendency to migrate, subside, and be expulsed from the implant site.” Id. at *11. The court explained that, under Arizona law, a manufacturing defect is a “flaw[] as a result of something that went wrong in the manufacturing process.” Id. at *12 (citations omitted). The court held that the plaintiff’s “conclusory allegations” were “insufficient to state a plausible” manufacturing defect claim. Id.

Design Defect: The plaintiff alleged that the spinal fixation system had design defects that prevented the plaintiff’s spine from fusing. Because the plaintiff’s design defect claim did not “clearly identify whether [it was] based in negligence or strict liability,” id. at *15-16, the court considered both possibilities, and held that the plaintiff’s pleadings did not satisfy either standard.  The facts asserted in the complaint did not “support [a] claim that the . . . spinal fixation system fail[ed] to meet the purpose for which it was designed,” as a negligent design claim would require, according to the court.  Nor did the complaint adequately allege that the spinal fixation system “was unreasonably dangerous and failed to perform in a reasonably safe manner” or that its benefits did not outweigh its risks, alternate tests of a strict liability – design defect claim. Id. at *17. As such, the court held, the plaintiff had not pled a plausible design defect claim sounding in either negligence or strict liability

Failure to Warn: Because the fusion devices were Class III medical devices, any warnings claims were subject to express preemption under Riegel. The court explained that, “in order to avoid preemption, a plaintiff has to sue for conduct that violates a federal requirement . . . but cannot sue only because the conduct violates that federal requirement ([to avoid] implied [Buckman] preemption).” Id. at *19. Here, the plaintiff alleged that, because the (allegedly) “correct” fusion device failed to include certain warnings required by FDA, she was implanted with the “wrong” fusion device. Problem was, the defendants asked the judge to take judicial notice of the 2009 label, presumably in effect for the plaintiff’s 2010 surgery, which contained the specific warning the plaintiff alleged was missing.   The plaintiff admitted that she hadn’t been able to find that label – she only had labels from 2002 and 2015. You know what the court held here. (We would have had fun briefing the “warnings causation” argument if, in fact, plaintiff had been allowed to proceed with a claim that a warning was allegedly missing from a product that was never implanted in her.)

The judge similarly dispatched “adulteration” and “misbranding” claims.   The “adulteration” claim was based on the substitution of one fusion device for the other, which, the court observed, was effected by the surgeon, not the defendants. The misbranding claim made little enough sense that we won’t belabor it except to note that the court held that the claim “[flew] in the face of logic.” Id. at *23.

In sum, the complaint was a “hot mess,” in the words of some new Tennessee friends we made this week, and it mercifully and properly was dismissed.   We really like this decision, especially the judicial eye rolling evident throughout. We’ll keep you posted on similar victories. Meanwhile, if you are going to be in western Tennessee, email us and we’ll point you in the direction of the ducks!

 

 

 

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Donald Rumsfeld once justified attacking Iraq without firm evidence that his target possessed the ultimately apocryphal “weapons of mass destruction” by citing fear of the unknown:

Reports that say that something hasn’t happened are always interesting to me, because as we know, there are known knowns; there are things we know we know.  We also know there are known unknowns; that is to say we know there are some things we do not know.  But there are also unknown unknowns − the ones we don’t know we don’t know.  And if one looks throughout the history of our country and other free countries, it is the latter category that tend to be the difficult ones.

That worked really well in Iraq.  But it works even worse with differential etiology, often referred to, not particularly correctly, as “differential diagnosis.”  That’s because the “differential” part of this testimonial technique is really just a form of circumstantial evidence – a “process of elimination.”  “Differential diagnosis is accomplished by determining the possible causes for the patient’s symptoms and then eliminating each of these potential causes until reaching one that cannot be ruled out or determining which of those that cannot be excluded is the most likely.”  Guinn v. AstraZeneca Pharmaceuticals LP, 602 F.3d 1245, 1253 (11th Cir. 2010).  It is “a process of identifying external causes by a process of elimination.”  McClain v. Metabolife International, Inc., 401 F.3d 1233, 1252 (11th Cir. 2005).

A differential etiology is a process-of-elimination approach to determining a subject’s cause of injury.  Under this method, an expert considers all relevant potential causes of the symptoms and then eliminates alternative causes.  Although the parties and the district court below refer to this method as a “differential diagnosis,” that term is really a misnomer.  A “diagnosis” is concerned only about naming the condition or ailment, not establishing its cause.

C.W. v. Textron, Inc., 807 F.3d 827, 832 n.4 (7th Cir. 2015) (citation omitted).

“Unknowns” are a recurring problem with this “differential” process.  If one doesn’t know what the possible causes are, then it will be impossible to eliminate them from the equation.  A significant level of idiosyncratic causation is fatal to the valid use of differential etiology.

Although differential etiologies are a sound methodology in principle, this approach is only valid if general causation exists and a substantial proportion of competing causes are known.  Thus, for diseases for which the causes are largely unknown, such as most birth defects, a differential etiology is of little benefit.

Michael D. Green, et al., “Reference Guide on Epidemiology,” in Federal Judicial Center, Reference Manual on Scientific Evidence 549, 618 (3d ed. 2011).

This technique is more accurately described as a “differential etiology.”  It is most useful when the causes of a substantial proportion of the disease are known. . . .  When the causes of a disease are largely unknown . . ., differential etiology is of little assistance.

Restatement (Third) of Torts:  Physical & Emotional Harm § 28, comment c(4) (2010).

The validity of a differential diagnosis depends on a substantial proportion of the independent causes of the disease being known. . . .  A differential diagnosis is of limited utility when a substantial portion of the incidence of a disease is of unknown etiology.

Id. at Reporter’s Notes to comment c(4).

The Third Restatement relies on commentary that has long understood that “unknowns” preclude the proper use of differential etiology:

[It] becomes particularly important when . . . one cannot assume that most causes of any given ailment are known.  Otherwise, . . . the elimination of other risk factors would not significantly increase the likelihood that the exposure was the cause of the plaintiff’s injury.  In such situations, one cannot make a Sherlock Holmes-like deduction that simply because all other known causes have been eliminated, the only known cause left, no matter how improbable, must be the actual cause.

Joseph Sanders & Julie Machal-Fulks, “The Admissibility of Differential Diagnosis Testimony to Prove Causation in Toxic Tort Cases:  The Interplay of Adjective & Substantive Law,” Law & Contemp. Probs., 107, 133-34 (Autumn 2001).  Differential etiology “can only be valid, however, when risk factors that account for most cases of the plaintiff’s injury and their interactions are understood.”  Susan R. Poulter, “Science & Toxic Torts: Is There A Rational Solution to the Problem of Causation?, 7 High Tech. L.J. 189, 235 (1992).

Plentiful precedent likewise recognizes the incompetency of differential etiology where the condition at issue is often idiopathic in nature.  “Because idiopathy accounts for more than half of the cases of [the disease at issue], a differential diagnosis could be considered inherently unreliable here.”  Hall v. Conoco Inc., 886 F.3d 1308, 1315 (10th Cir. 2018) (affirming exclusion).

[T]hat decision is particularly critical here given the extensive number of [disease] cases that are idiopathic.  Under such circumstances, eliminating a number of potential causes − without properly and explicitly “ruling in” a cause − is simply “of little assistance.” . . .  [Plaintiff’s expert] needed some other method to “rule out” an idiopathic diagnosis.  She did not provide one.  As such, the district court acted within its discretion to conclude that the extraordinary number of idiopathic [] cases, coupled with the lack of a reliable means to rule out an idiopathic diagnosis here, muted [plaintiff’s expert’s] ability to reliably apply this methodology.

Milward v. Rust-Oleum Corp., 820 F.3d 469, 476 (1st Cir. 2016) (quoting Restatement Third, §28, comment c(4), discussed above).  Similarly, in Kilpatrick v. Breg, Inc., 613 F.3d 1329 (11th Cir. 2010), the plaintiff’s expert “clearly testified that he could not explain why potentially unknown, or idiopathic alternative causes were not ruled out. . . .  Thus, the key foundation for applying differential diagnosis was missing.”  Id. at 1343.

[Plaintiff’s expert] ignored such background risks.  While recognizing the existence of idiopathic (or unknown) causes of [the condition], he dismissed them by merely stating that the risk of idiopathic [disease] is essentially zero.  The failure to take into account the potential for idiopathically occurring [disease] − particularly when [this condition] is a relatively new phenomenon in need of further study − placed the reliability of [the expert’s] conclusions in further doubt.

Id. at 1342 (citations to McClain, supra, omitted).  Accord Chapman v. Procter & Gamble Distributing, LLC, 766 F.3d 1296, 1311 (11th Cir. 2014) (following Kilpatrick; one reason being that plaintiff’s expert “omitted consideration of idiopathic causes for [plaintiff’s condition], additionally rendering his differential diagnosis unreliable”).

An early post-Daubert case, Black v. Food Lion, Inc., 171 F.3d 308 (5th Cir. 1999), similarly affirmed exclusion of an opinion since:

neither [the expert] nor medical science knows the exact process that results in [the condition] or the factors that trigger the process.  Absent these critical scientific predicates, . . .  no scientifically reliable conclusion on causation can be drawn.

Id. at 314.  In Bland v. Verizon Wireless, (VAW) LLC, 538 F.3d 893, 897 (8th Cir. 2008), held that an expert’s “attempt to use a differential diagnosis . . . fails because . . . the cause of [the condition] in the majority of cases is unknown.”  Id. at 897.  Likewise, in Tamraz v. Lincoln Electric Co., 620 F.3d 665, 675 (6th Cir. 2010), “the other possibility − unknown (idiopathic) causation − currently accounts for the vast majority of [the disease’s] cases, making it impossible to ignore and difficult to rule out . . . via a differential-diagnosis.”  Id. at 675.

State, as well as federal, appellate courts have recognized the fundamental incompatibility between the circumstantial method of proof represented by differential etiology and the presence of significant unknown causal factors.  In Blackwell v. Wyeth, 971 A.2d 235 (Md. 2009), for example, the court affirmed exclusion of an expert whose purported differential diagnosis ignored “unknown genetics,” holding that:

[The trial court] did not err in finding that a gene or series of interacting genes that have not yet been identified is the “most prevalent alleged cause of [the condition], based upon our review of the record.  We agree that [plaintiff’s expert] did not sufficiently consider genetics in his differential diagnosis equation.

Id. at 260.  This failure to consider medically unknown causes meant that the expert’s “theory is no more than hypothesis and conjecture.”  Id. at 261.

Likewise, Valentine v. PPG Industries, Inc., 821 N.E.2d 580 (Ohio App. 2004), recognized that “[t]o state that nothing else caused the [plaintiff’s injury] is contrary to the medical and scientific fact that the cause of [that injury] is unknown.”  Id. at 599.

At this point, medical science does not enable physicians and other scientists to pinpoint a cause. . . .  Thus, under the circumstances of this case . . . differential diagnosis is not a reliable technique for identifying causation. . . .  [T]he present state of scientific knowledge on the cause of [the disease] precludes reliability in this context.

Id. at 599-600.  The Ohio Supreme Court affirmed, holding that “[a]lthough differential diagnosis is a standard scientific method for determining causation, its use is appropriate only when considering potential causes that are scientifically known.”  Valentine v. Conrad, 850 N.E.2d 683, 688 (Ohio 2006) (citation omitted).  See Blanchard v. Goodyear Tire & Rubber, 30 A.3d 1271, 1277 (Vt. 2011) (“a large percentage of cases of plaintiff’s type . . . are of unknown origin, so any attempt to establish causation by ruling out other causes must fail”); Garcia v. City of New Orleans, 115 So.3d 515, 519 (La. App. 2013) (by admitting “that it is possible that the [condition] was idiopathic,” plaintiff’s expert “did not perform a differential diagnosis”); Kerns v. Hobart Brothers Co., 2008 WL 1991909, at *8 (Ohio App. May 9, 2008) (following Valentine; “It is axiomatic that one cannot rule out causes that are unknown or unable to be properly discerned and isolated.”); Coastal Tankships, U.S.A., Inc. v. Anderson, 87 S.W.3d 591, 614 (Tex. App. 2002) (“in this case there are both unknown and ubiquitous causes, both of which it is impossible to ‘rule out’”).  Cf. Johnson & Johnson Talcum Powder Cases, 249 Cal. Rptr.3d 642, 676 (Cal. App. 2019) (recognizing that “a differential diagnosis alone may be insufficient as the sole basis for an opinion on the etiology of a largely idiopathic disease”; holding “that is not the situation before us”).

Lots of trial-level cases reach the same result.  In Soldo v. Sandoz Pharmaceuticals Corp., unknown causes were fatal to the plaintiff’s attempted differential etiology:

[G]iven plaintiff’s experts’ admissions that many [incidents] occur for which a particular cause cannot be ascertained even after extensive investigation, consistent application of their own methodology requires them to rule out such idiopathic [incidents] before reliably concluding that [the drug] caused [this incident].  It is impossible to reasonably rule out a cause that cannot even be specifically identified.

Id. at 517.  See G v. Fay School, Inc., 282 F. Supp.3d 381, 391 (D. Mass. 2017) (plaintiff’s expert’s “use of the differential diagnosis method failed to reasonably survey other potential causes” because she “neglects to account for the possibility of an idiopathic etiology”), aff’d, 931 F.3d 1 (1st Cir. 2019); Jones v. Novartis Pharmaceuticals Corp., 235 F. Supp.3d 1244, 1280 (N.D. Ala. 2017) (“However, an unreliable application of a background risk methodology leads to the same result as a failure to consider the background risk at all: the expert’s opinion will be excluded.”), aff’d, 720 F. Appx. 1006 (11th Cir. 2018); K.E. v. GlaxoSmithKline LLC, 2017 WL 440242, at *16 (D. Conn. Feb. 1, 2017) (“Since both parties agree that [plaintiff’s condition] can be caused by a variety of factors and that the majority . . . have an unknown cause, these omissions further reveal the inadequacy of the differential diagnosis performed here.”); McCarty v. Arch Wood Protection, Inc., 2016 WL 1306067, at *7 (E.D. Ky. March 31, 2016) (“Plaintiffs’ experts did not perform a reliable differential diagnosis because they did not rule out an idiopathic origin”); Hendrian v. Safety-Kleen Systems, Inc., 2014 WL 1464462, at *7 (E.D. Mich. April 15, 2014) (“Plaintiff makes no attempt at explaining how, if at all, [her expert] ‘ruled out’ all potential alternative causes, including, most importantly . . ., idiopathic origin”); In re Denture Cream Products Liability Litigation, 795 F. Supp.2d 1345, 1367 (S.D. Fla. 2011) (plaintiffs’ expert “did not perform a reliable differential diagnosis” because he “did not consider the possibility of an idiopathic cause”); Nozinich v. Johnson & Johnson, Inc., 2011 WL 13124085, at *10 (W.D. Tenn. July 6, 2011) (due to “idiopathic causes,” the plaintiff’s expert’s “differential diagnosis was flawed”); Pritchard v. Dow Agro Sciences, 705 F. Supp.2d 471, 492 (W.D. Pa. 2010) (excluding expert who “did not attempt to rule out that [plaintiff’s condition] is the result of an idiopathic or unknown cause despite the fact that the general cause of [that condition] is unknown”), aff’d, 430 F. Appx. 102 (3d Cir. 2011); Henricksen v. Conoco Phillips Co., 605 F. Supp.2d 1142, 1162 (E.D. Wash. 2009) (“the presence of a known risk factor is not a sufficient basis for ruling out idiopathic origin in a particular case, particularly where most cases of the disease have no known cause.  [I]n [these] cases, analysis beyond a differential diagnosis is required.”); Perry v. Novartis Pharmaceuticals Corp., 564 F. Supp.2d 452, 470 (E.D. Pa. 2008) (“Standing alone, the presence of a known risk factor is not a sufficient basis for ruling out idiopathic origin in a particular case, particularly where most cases of the disease have no known cause.”); Redfoot v. B.F. Ascher & Co., 2007 WL 1593239, at *11 (N.D. Cal. June 1, 2007) (“differential diagnosis is faulty because [the expert] failed to consider . . . that the cause of [the disease] is not known today”); Doe 2 v. OrthoClinical Diagnostics, Inc., 440 F. Supp.2d 465, 477-78 (M.D.N.C. 2006) (“Although [the expert] apparently has considered a number of specific genetic disorders in performing his differential diagnosis, the Court finds that his failure to take into account the existence of such a strong likelihood of a currently unknown genetic cause . . . serves to negate [his] use of the differential diagnosis technique as being proper in this instance.”); Cano v. Everest Minerals Corp., 362 F. Supp.2d 814, 846 (W.D. Tex. 2005) (“given that [plaintiff’s expert] does not appear to consider . . . unknown origins, it is possible that none of the possible causes he lists was an actual cause”; opinion excluded) (footnote omitted); Nelson v. American Home Products Corp., 92 F. Supp.2d 954, 971 (W.D. Mo. 2000) (“With no other basis for ruling out idiopathic [disease], [plaintiff’s expert’s] differential diagnosis does not constitute reliable scientific knowledge.”); Whiting v. Boston Edison Co., 891 F. Supp. 12, 21 n.41 (D. Mass. 1995) (“If 90 percent of the causes of a disease are unknown, it is impossible to eliminate an unknown disease as the efficient cause of a patient’s illness.”); Zandi v. Wyeth, 2007 WL 3224242 (Minn. Dist. 2007) (plaintiff’s condition “does not lend itself to differential diagnosis because the scientific community has not accepted that [it]has a limited number of discrete and recognized possible causes such that ruling out one cause would implicate another”).

Finally, since we’ve discussed Wendell v. GlaxoSmithKline LLC, 858 F.3d 1227, 1237 (9th Cir. 2017), before, and included it in our bottom ten decisions of the year, we would be remiss not to point out that the Ninth Circuit has gone its unique, science-ignoring way on this issue:

Finally, the district court erred when it excluded Plaintiffs’ experts’ opinion testimony because of the high rate of idiopathic [occurrence] and the alleged inability of the experts to rule out an idiopathic origin. . . .  We do not require experts to eliminate all other possible causes of a condition for the expert’s testimony to be reliable.  It is enough that the proposed cause “be a substantial causative factor.”  This is true in patients with multiple risk factors, and analogously, in cases where there is a high rate of idiopathy.

Id. at 1237 (citations omitted).  That’s the sum total of Wendell’s reasoning – ignoring unknown causes is OK “by analogy” to cases with multiple known risk factors.  That’s pretty thin gruel to reverse a discretionary Daubert ruling, we think, but Wendell is out there, so anyone arguing this issue needs to be aware of Wendell and deal with its flabby rationale.

But on the whole, “[a] rose by another name may smell as sweet − but simply calling an analysis a differential diagnosis doesn’t make it so.”  In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation (No II) MDL 2502, 892 F.3d 624, 643 (4th Cir. 2018).  One way that commonly happens is experts ignoring an elephant in the room – a significant possibility that the disease or condition at issue arose from unknown causes.  Since differential etiology is simply a form of circumstantial evidence – ruling out all other significant possible causes – any significant likelihood of idiopathic causation blows a fatal hole in this methodology.

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One size does not in fact fit all.  Cookie cutters are great for ensuring uniformity.  The type of uniformity you want on a beautiful dessert tray.  Uniform size, shape, and color appeal to the eye.  It’s precise.  It’s inviting.  And while the term “mass tort” may conjure up the image of complaint after complaint stamped from the same mold – in fact, personal injury mass torts are more like good old-fashioned, homemade drop cookies.  Think chocolate chips.  For the most part, they are all basically round.  Usually close in size.  And most similar in taste.  But they are far from identical.  They have bumpy edges and lumpy surfaces.  No two have the same number of chips.  Some are just a tad softer than others.  Some fall apart as soon as you pick them up.  One can never be the clone of another.  That’s the way complaints are in mass torts.  Overlap, similarities – sure.  But if you use cut and paste, you better make sure you’re copying the right thing.

That was the primary downfall of plaintiff in Green v. Coviden, 2019 WL 4142480 (S.D.N.Y. Aug. 30, 2019).  Plaintiff underwent a hernia repair surgery during which defendant’s Symbotex Mesh was implanted.  Following the need for revision surgery, plaintiff brought suit for strict liability, negligence, breach of warranty, fraudulent and negligent misrepresentation, unjust enrichment, and consumer fraud.  Id. at *1.

To support her claims, plaintiff alleged that “microporous mesh” has a higher risk of infection and seroma and that “lightweight mesh” cannot adhere as well as others to the abdominal wall.  Id. at *2.  However, the Symbotex Mesh used in plaintiff’s surgery was a macroporous mesh.  Plaintiff had to concede that her complaint was about the wrong product.  Prompting this response from the court:

Accordingly, the factual predicate for Plaintiff’s defective design claim is admittedly false, and this sloppy error alone requires that Plaintiff’s defective design claim be dismissed.

Id.  The court further admonished that plaintiff couldn’t amend her complaint by correcting the allegations in her opposition brief.  Wrong facts, wrong product, no claim.  No breach of warranty claim either.  Id. at *5-6.

But that’s not where the “cookie cutter” allegations end.  Even if the complaint had accurate facts, plaintiff’s design defect claim failed because “[s]imply  asserting that a feasible alternative design exists – without pleading any supporting facts – is not sufficient to plead a defective design claim or to put Defendant on notice as to what that design might be.”  Id. at *3.  What something else “cookie cutter” complaints have in common – a lack of detail.  How else do you make allegations to fit any occasion?  Plaintiff also alleged that there are “safer alternatives” to using mesh for hernia repairs, but “alleging that the product should not be used at all” is not the same as pleading an alternate design.  Id.

Plaintiff’s manufacturing defect claim suffered a similar fate because plaintiff didn’t plead any facts demonstrating defendant’s manufacturing process was flawed or how the device deviated from the standard design.  Id.  More empty allegations.  Plaintiff argued that she was relying on circumstantial evidence – she was injured, therefore the product did not do what it was intended to do and so it must be defective.  If this were allowed, it would be the perfect “cookie cutter” allegation.  No supporting facts needed.  Injury equals defect.  But the court has this say:

This is a non-sequitur. Defective manufacturing is not shown merely by proof that a consumer was injured, and by asserting that the product was not intended to injure its user.  If Plaintiff is going to rely on the circumstantial theory of liability . . . she must allege [facts] to nudge her claim above the level of speculation and into the realm of the plausible.

Id. at *4.  Plaintiffs’ allegations here further missed the mark because the injuries she alleges “are among the complications listed on the [device’s] warning label.”  Id.  The fact that the very risk warned about occurred can hardly justify a manufacturing defect claim without more.  A whole lot more.

And that brings us nicely to plaintiff’s failure to warn claim.  Once again, “cookie cutter” pleading is plaintiff’s downfall.  Plaintiff’s complaint includes an allegation that defendant’s mesh came with a warning about recurrence, adhesions, and pain, among other things.  Id.  Plaintiff’s complaint also alleges that her injuries were “recurring hernias, pain and adhesions.”  Id. at *5.  If you are going to claim a failure to warn, you should probably make sure your own allegations don’t include warnings about the very risks you suffered.

Finally, plaintiff alleged fraud and misrepresentation claims which are subject to Rule 9(b) heightened pleading standards.  If “cookie cutter” allegations weren’t enough for the other causes of action – they didn’t stand a chance against Rule 9(b).  As with her other claims, plaintiff did not “quote or describe the alleged misrepresentations.”  Id. at *8.  Plaintiff pointed to a lot of web addresses, but most were nonfunctional and even so, it’s not enough to generally allege a website contains false statements without specifying which statements are allegedly false or misleading.  The one statement the complaint did specifically point to, plaintiff failed to explain why the statement was false or misleading.  Id.  Plaintiff’s consumer fraud claim failed for the same reason.  Id. at *9-10.  It’s easy to use “cookie cutter” allegations if you keep everything high-level and non-specific.  But, TwIqbal demands more.

The court also threw out plaintiff’s unjust enrichment claim as not available in routine product liability actions.  It is not viable if it simply duplicates the tort action.  Id. at *9.

We know the law consists of forms and standard procedures.  We all stand on the shoulders of those who have gone before us.  Borrowing from arguments won here, incorporating defenses successful there.  Nobody wants to reinvent the wheel.  But, if you’re going to be sloppy about it, you’re going to find yourself with nothing more than a plate of crumbs.

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Few things raise our blood pressure as much as the MDL process. MDL stands for Multi-District Litigation, but the M might as well stand for Mutilating and the D for Distorting. One-sided discovery, wholesale parking of ‘shotgun’ complaints, made-up spoliation issues, and bellwether trial programs that produce results representative of nothing other than plaintiff lawyer dreams all wreak havoc on our systolic and diastolic numbers. For a while we harbored hopes that the Joint Panel on Multidistrict Litigation might be clamping down on creating drug and device MDLs, or at least narrowing them down.

Now? Not so much.

Let’s push the salt shaker away, ignore the latest demand for money from the heirs, count to ten, and take a look at In re: Valsartan N-Nitrosodimethylamine Ndma Contamination Prods. Liab. Lit., 2019 U.S. Dist LEXIS 24045, (JPML February 14, 2019), to see how the JPML ruled regarding creation of an MDL for valsartan, a medication indicated for treating hypertension. The litigation arises out of an investigation by the FDA into impurities found in drug products containing valsartan. Purchasers of recalled lots of generic valsartan subsequently filed actions alleging economic losses. The initial wave of consumer class actions was followed by actions alleging personal injuries from the ingestion of affected valsartan medications, as well as other related litigations.

After enough (query what is really “enough”) actions were filed, the MDL dance commenced. First, there were plaintiff purchasers suing for economic damages and related injunctive relief. They moved to centralize 10 actions in the District of New Jersey. Then came 30 “related” actions: 17 for personal injury and the remainder were putative class actions on behalf of consumers and third-party payors. Different parties plumped for different jurisdictions. Surprisingly, not everyone yearns for New Jersey. Other suggested districts were the Northern District of California, the Northern District of Florida, the District of Massachusetts, the District of Minnesota, and the Western District of Texas. Notice that none of these jurisdictions is likely to receive a Chamber of Commerce Award for Niceness to Corporate Defendants. Plaintiffs in two of the actions supported centralization only of the consumer class actions and sought the District of New Jersey. A plaintiff in one potential tag-along action on behalf of third-party payors sought inclusion of its action and requested the Southern District of Florida or the District of New Jersey.

The principal common defendants in this litigation supported centralization of the 10 actions in the District of New Jersey. They asked the Panel to limit the scope of the MDL solely to consumer class actions. Some defendants opposed inclusion of any of the actions against them, and certainly actions involving personal injuries, and alternatively, requested the District of New Jersey or the Northern District of West Virginia. Other responding defendants opposed certain permutations of centralization, suggesting that an MDL may not be warranted on the ground that alternatives to centralization exist, particularly transfer under Section 1404(a).

The JPML ruled that all the valsartan actions involved common factual questions arising out of allegations that plaintiffs purchased or used generic formulations of valsartan medications containing certain impurities possibly presenting risks of cancer and liver damage; and that defendants knew or should have known, of the impurities as early as 2012. All actions stemmed from the same FDA investigation and voluntary recall. Accordingly, the JPML reasoned that centralization would eliminate duplicative discovery; prevent inconsistent pretrial rulings, including with respect to class certification and Daubert motions; and conserve the resources of the parties, their counsel, and the judiciary.

The primary dispute hovered around whether the personal injury claims should be lumped in with the economic claims (both the direct and third-party payor cases). It is not hard to think of why those claims should be treated separately. But the JPML believed that the “core factual issues in the personal injury actions will be the same as in the consumer class actions.” Those issues included the cause of the alleged impurities; the nature and extent of the health risks they posed; the defendants’ knowledge of the alleged impurities; and the impact of any findings made by the FDA.

The JPML expressed no opinion as to whether this MDL “will grow to include actions involving other medications in the same class as valsartan.” Yikes. This could get messy. The court rejected Section 1404 transfer as a practicable alternative to centralization, “given the number of actions, districts, and counsel for plaintiffs and defendants. There are presently a total of 40 related actions pending in 22 districts, which involve over a dozen district slates of plaintiffs’ counsel and some 20 defendants, most of whom do not share counsel. These circumstances portend significant inefficiencies and obstacles to Section 1404 transfer if the related actions to a single district.”

After seeing above how many of the parties smiled on the Garden State, you will not be surprised to learn that the JPML deemed the District of New Jersey as an appropriate transferee district for this litigation. Five actions on the motion and seven potential tag-along actions were already pending there. Many of the defendants have their U.S. headquarters in New Jersey.

Congrats, valsartan litigants. Make sure you find your way to Jimmy Buff’s for Newark hotdogs. They might not be good for your blood pressure, but they sure are good eating. Or say hello to our friends at Star Tavern in Orange. We bet you’ll like Jersey thin pizza more than you’ll like Jersey discovery rulings.

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We had been waiting for the Utah Supreme Court’s decision in Burningham v. Wright Medical for some time.  As we pointed out in a blogpost when Burningham was first certified by the district court (Utah is one of the few courts allowing district court certification), over a year ago, “[p]ractically no court has . . . treat[ed] prescription drugs and prescription medical devices differently under [Restatement (Second) of Torts §402A] comment k [(1965)].”  We presented a 50 state survey indicating that was so – whether the state had adopted an “across-the-board” or a “case-by-case” approach to comment k.  Likewise the Third Restatement had treated all prescription medical products identically, even though it used a different test than comment k.

The Utah Supreme Court in Burningham accepted certification of four questions:

  1. Under Utah law, does the unavoidably unsafe exception to strict products liability in design defect claims recognized in Comment k to Section 402A of the Restatement (Second) of Torts apply to implanted medical devices?

  2. If the answer to Question 1 is in the affirmative, does the exception apply categorically to all implanted medical devices, or does the exception apply only to some devices on a case-by-case basis?

  3. If the exception applies on a case-by-case basis, what is the proper analysis to determine whether the exception applies?

  4. If the answer to Question 1 is in the affirmative, does the exception require a showing that such devices were cleared for market through the FDA’s premarket approval process as opposed to the § 510(k) clearance process?

Burningham v. Wright Medical Technology, Inc., ___ P.3d ___, 2019 WL 4231947, at *2 (Utah Sept. 5, 2019).

Well, last week, Burningham decided to go its own way, not even mentioning the overwhelming precedent to the contrary.  In a prescription drug case, Grundberg v. Upjohn Co., 813 P.2d 89 (Utah 1991), almost “thirty years ago,” “this court agreed ‘with the principle comment k embodies, that manufacturers of unavoidably dangerous products should not be liable for a claim of design defect” and “categorically immunize[d] all prescription drugs from strict liability design defect claims.”  Burningham, 2019 WL 4231947, at *3 (quoting Grundberg, 813 P.3d at 95).

Grundberg had followed Brown v. Superior Court, 751 P.2d 470, 475-83 (Cal. 1988), in applying comment k across the board to abolish prescription drug design defect strict liability.  At the time (we were younger and less jaded than now), we had hoped that would become a trend, but it didn’t – so we’re now counting on preemption instead.  But when Burningham was accepted, our greatest fear was that the court would reverse Grundberg.  Fortunately, that didn’t happen.  Instead, Burningham reiterated the “compelling reason” that undergirds Grundberg:

And we are still cognizant of the problems associated with such a[ case-by-case] approach.  But we were able to avoid those problems in suits involving prescription drugs only because of the rigorous FDA approval process to which they were subject.

2019 WL 4231947, at *6.  So prescription drug design defect cases remain barred by Utah state law.  The worst was avoided.

In initially sorting out the four certified questions, Burningham did something that manufacturers of FDA pre-market approved (“PMA”) medical devices will like quite a bit.  It declined to answer the final question on the basis of federal preemption:

In Riegel v. Medtronic, Inc., the Court held that the MDA preempts state law tort claims involving PMA-approved medical devices.  See 552 U.S. 312, 321-25 (2008). . . .  The fourth certified question asks whether the unavoidably unsafe exception requires a showing that the implanted medical device was cleared for market through the PMA process rather than the 510(k) process.  However, Riegel holds that all state law tort claims, including strict liability design defect claims, involving a PMA-approved device are preempted by the MDA. So, regardless of our conclusion as to whether a PMA-approved device should be deemed unavoidably unsafe as a matter of law, such devices are already immune from strict products liability claims.

So, with regard to question four, we do not opine on whether PMA-approved medical devices are unavoidably unsafe as a matter of law because they are already exempt from all state product liability claims.

2019 WL 4231947, at *5-6 (emphasis added).  See Id. at *9 (“PMA-approved medical devices . . . are already exempt from all state products liability claims under [Riegel]”).  So the good news for any PMA medical device manufacturer facing a Utah-law suit is that the state’s highest court has held, in no uncertain terms, that all state-law claims are preempted.  Utah evidently doesn’t follow the Riegel dictum that has fooled so many courts into allowing so-called “parallel” violation claims.  Utah went its own way.

But that’s all the good news out of Burningham.  Trading thirty-year-old precedent for an outdated (and almost as old) view of the FDA’s §510(k) “substantial equivalence” device clearance procedure, Burningham relies on Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), and Goodlin v. Medtronic, Inc., 167 F.3d 1367 (11th Cir. 1999) (citing Lohr), to denigrate 510(k) clearance as insufficiently rigorous to justify applying Grundberg to such medical devices.  2019 WL 4231947, at *4-5.

To extend our reasoning in Grundberg to the medical device or any other context would require an equally compelling reason, such as a similarly rigorous oversight process.

Based on the applicable regulations, we are not persuaded that 510(k) is such a process.  Comment k’s premise is that there are some products that are “incapable of being made safe for their intended and ordinary use.”  Without an FDA evaluation of a medical device’s safety, we cannot know whether the device is incapable of being made safe (although it is beneficial), or whether it is “unreasonably dangerous.”

Id. at *6 (quoting comment k).

As we laid out in great detail in our “Lohr Has Two Shadows” post, the 510(k) process that Lohr (and cases like Goodlin that parrot Lohr) described no longer exists.  Rather, Congress revamped the relevant statutory sections in the Safe Medical Devices Act (“SMDA”) to impose the same “reasonable assurance of safety and effectiveness” standard to 510(k) that Lohr (and later Riegel) held would have preemptive effect.  21 U.S.C. §360c(f)(2)(a)(v).  But nobody on the bench seems to care.  It’s almost as if there is a judicial conspiracy of silence in product liability cases with respect to the SMDA.

End of rant.

Be that as it may, in Burningham, the Court used its view of “substantial equivalence” to apply a case-by-case” comment k approach to 510(k) medical devices while retaining the “across-the-board” approach for prescription drugs.

[W]e answer the first certified question conditionally.  Although the unavoidably unsafe exception might immunize some implanted medical devices from strict products liability, when such a device enters the market through the 510(k) process, we cannot say that this will always be the case as a matter of law.

2019 WL 4231947, at *7.  Therefore some sort of case-by-case approach necessarily applied.  “Accordingly, the answer to the second question is that courts applying Utah law should treat this exception as an affirmative defense to be determined by the factfinder on a case-by-case basis.”  Id.

Burningham tossed defendants some crumbs in exactly what this “affirmative defense” would look like.  Plaintiffs had argued that, in addition to proving that the device was unavoidably unsafe, defendants also had to prove that the product was “properly manufactured” and had “adequate warnings.”  Id.  The Utah Supreme Court held that, no, defendants did not have to prove the negative of manufacturing and warning defect claims in order to satisfy comment k.  Rather, plaintiffs retained the burden of proof on those other kinds of defects.  Grundberg did not “treat proper preparation and adequate warnings as elements of the unavoidably unsafe affirmative defense.”  Id. at *8.

Rather, these are separate claims a plaintiff must make and prove.  If a plaintiff alleges manufacturing flaws or inadequate warnings and the factfinder finds the plaintiff has proved either one by a preponderance of the evidence, then the unavoidably unsafe exception is unavailable to a defendant as an affirmative defense.  But if the plaintiff does not raise either claim, or is unable to prove them, the exception is available to the defendant.

Id.  That’s better than nothing, but experience has taught us that having to prove over and over again to multiple juries what the same defendant already had to prove to the FDA is an expensive and wasteful process, leading to Pyrrhic victories, or worse to lay juries disregarding the FDA’s marketing clearances.

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We’ve blogged numerous times about the tentative, non-final, and informal status of FDA warning letters (and untitled letters and similar enforcement precursors like Form 483s).  We’ve cited precedent, FDA internal manuals, FDA’s own position taken in formal briefing, and learned treatises on FDA law.  That an FDA warning letter has no binding legal effect (indeed, they are not even reviewed by FDA’s lawyers before they are issued) has seemingly been answered authoritatively over and over again.  Yet, still we see goofy results like this:

Defendant moves to exclude any evidence, including expert testimony, regarding the [FDA] Form 483, [] Warning Letter, and [second] Form 483 arguing the evidence is irrelevant and that any probative value is exceeded by unfair prejudice to Defendant.  The Court disagrees.  All three documents relate to the [product plaintiff] was [using], and they are relevant to whether Defendant complied with federal regulations regarding product complaints and implementation of corrective and preventative action.  Moreover, the documents are relevant to when and whether the [product performed appropriately].

In addition, the Court finds that the probative value of [these three documents] outweighs any prejudice to the Defendant.

Godelia v. Zoll Services, LLC, 2019 WL 3883682, at *3 (S.D. Fla. Aug. 16, 2019).  No citations omitted – the decision didn’t bother to cite anything for its result.

Perhaps we need to go further.  Maybe the problem here is that pro-plaintiff judges ignore the FDA law because it isn’t binding on them.  We’ve pretty much beaten the FDA law to death, so it could be time to look elsewhere.  Interestingly, we found the following in a case decided only three days after Godelia:

As stressed by Defendants, it is well-established that an “investigation that has not resulted in charges or any finding of wrongdoing does not support an inference of scienter.”  In re Hertz Global Holdings, Inc. Securities Litigation, 2017 WL 1536223, at *17 n.6 (D.N.J. April 27, 2017) (citing Brophy v. Jiangbo Pharmaceuticals, Inc., 781 F.3d 1296, 1304 (11th Cir. 2015) (“The ‘mere existence of an SEC investigation’ likewise does not equip a reviewing court to explain which inferences might be available beyond a general suspicion of wrongdoing.”), aff’d, 905 F.3d 106 (3d Cir. 2018)).  Such an investigation “is not evidence of fraud, or even negligence or mistake.”  Southeastern Pennsylvania Transportation Authority v. Orrstown Financial Services, Inc., 2016 WL 7117455, at *11 (M.D. Pa. Dec. 7, 2016) (citing Meyer v. Greene, 710 F.3d 1189, 1201 (11th Cir. 2013) (“The announcement of an investigation reveals just that − an investigation − and nothing more.”)); see also Utesch v. Lannett Company, Inc., 316 F. Supp.3d 895, 903-04 (E.D. Pa. 2018) (holding that the existence of a government inquiry alone is not sufficient to raise a strong inference of scienter).

Teamsters Local 456 Pension Fund v. Universal Health Services, ___ F. Supp.3d ___, 2019 WL 3886839, at *40 (E.D. Pa. Aug. 19, 2019) (citations not omitted, either, although some have received non-substantive modifications).

What struck us in particular about Local 456 is that, unlike Godelia, it cited and followed Eleventh Circuit precedent.  Local 456 isn’t even by an Eleventh Circuit court, whereas Godelia is.  So we started with the two Eleventh Circuit decisions Local 456 cited (but Godelia did not).  These were securities law cases, and they have different elements of proof than product liability, most notably the need to prove “scienter” (which is legal jargon that approximates “intent”).  The plaintiff in Brophy claimed that the mere fact of a governmental investigation was probative of this element.  The Eleventh Circuit called barnyard expletive on that argument.  “The ‘mere existence of [the government’s] investigation’ likewise does not equip a reviewing court to explain which inferences might be available beyond a general suspicion of wrongdoing.”  781 F.3d at 1305.  And that was on a motion to dismiss.

Brophy in turn quoted In re Hutchinson Technology, Inc. Securities Litigation, 536 F.3d 952 (8th Cir. 2008), which held that adding allegations to a complaint about a government investigation that had not resulted is a conviction was futile:

[W]e consider the [government’s] opening and closing an investigation irrelevant to the issue of [plaintiff’s] complaint sufficiency.  The mere existence of [this] investigation does not suggest that any of the allegedly false statements were actually false . . . nor does it add an inference of scienter.  Under either an abuse of discretion or a de novo standard of review, we agree . . . that [plaintiff] has not shown that any potential amendment would save its complaint.

Id. at 962.

The other Eleventh Circuit case cited in Local 452 was, if anything, even more emphatic:

The announcement of an investigation reveals just that − an investigation − and nothing more. . . .  That does not mean that [such] investigations, in and of themselves, reveal to the market that a company’s previous statements were false or fraudulent.

Meyer v. Greene, 710 F.3d 1189, 1201 (11th Cir. 2013) (citations omitted).  In other words, the simple existence of a governmental investigation cannot be grounds to infer that what the government was investigating was actually true.

In our little jaunt through securities litigation, we ran across some other appellate decisions for the same proposition.  The Ninth Circuit held that announcement of a governmental investigation cannot “plausibly” establish causation:

The announcement of an investigation does not “reveal” fraudulent practices to the market.  Indeed, at the moment an investigation is announced, the market cannot possibly know what the investigation will ultimately reveal.  While the disclosure of an investigation is certainly an ominous event, it simply puts investors on notice of a potential future disclosure of fraudulent conduct. Consequently, any decline in a corporation’s share price following the announcement of an investigation can only be attributed to market speculation. . . .  This type of speculation cannot form the basis of a viable loss causation theory.

Loos v. Immersion Corp., 762 F.3d 880, 890 (9th Cir. 2014).

Plaintiffs allege that the [government] is investigating [defendants] for fraud, but that assertion is too speculative to add much, if anything, to an inference of scienter.  In fact, defendants represented at oral argument − and plaintiffs did not dispute − that the [government’s] investigation has already settled without a finding of culpability.

Cozzarelli v. Inspire Pharmaceuticals, Inc., 549 F.3d 618, 628 n.2 (4th Cir. 2008).

Securities litigation is only one other kind of civil litigation, and SEC investigations are only one type of analogous governmental enforcement.  Defendants fearing that the law directly concerning FDA warning letters won’t be enough to deter a judge from letting plaintiffs rely on them – see Godelia − should seek precedential reinforcement elsewhere, since binding precedent may exist in any number of analogous areas.

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As your bloggers – at least those without school-aged children – begin to mourn the dawning end of summer, we do at least see one bright spot in the ever-shortening days: ACI’s annual Drug and Medical Device Litigation conference.

We’re looking forward to interesting presentations from the always-exceptional faculty of in-house counsel, top defense firms, experienced jurists, and members of the FDA and DOJ.

Several of your bloggers are already making plans to spend December 10-11 in New York, and we hope to have the chance to catch up with some of our loyal readers there. Bexis will of course be in his usual front-and-center seat if you’d like to chat.

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

  • First, the early bird discount for ACI ends September 27, making now a great time to register if you haven’t done so already as prices will increase.
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California courts continue to find ways to exercise personal jurisdiction over out-of-state defendants, even when there is little or no dispute that the Constitution and the United States Supreme Court’s opinion in Bristol-Meyers Squibb Co. v. Superior Court do not permit it.  “Resistance” is probably too strong a word, insofar as it calls up images of barricades in the streets or some other organized effort to thwart authority.  Or maybe it isn’t.  “Defiance” maybe?  We don’t know, but whatever you call it, there is an unmistakable inclination on the part of California’s courts—including in the now-reversed California Supreme Court opinion in the BMS case itself—to hold out-of-state defendants to answer, even to plaintiffs who have no connection with California either.

This all is a lead in to a second Petition for Certiorari from the Lipitor litigation to raise jurisdictional issues in the United States Supreme Court.  The issue is whether a defendant “forfeits” a perfectly valid personal jurisdiction defense by removing a case to federal court and actively litigating subject matter jurisdiction.  In a case of déjà vu all over again, Pfizer, Inc. v. Superior Court, No. 19-278, involves thousands of plaintiffs from all over the country who sued an out-of-state drug manufacturer in California state court alleging injuries in connection with a prescription drug.  (You can view the petition by going to the docket here and clicking on “petition.”)  Following a familiar playbook, the plaintiffs sought to avoid federal subject matter jurisdiction by dividing their action into multiple actions, each with fewer than one hundred plaintiffs.  They also made sure there was no complete diversity in any one complaint.  And, for good measure, they sued McKesson, which has been sued in California state court thousands of times for the sole reason that it used to have its principal place of business in California, but no longer does.

This scenario raises multiple jurisdictional issues.  On the one hand, this action appears to be removable to federal court as a mass action under the Class Action Fairness Act, an issue of subject matter jurisdiction.  On the other hand, California courts undisputedly have no personal jurisdiction over a defendant that neither is “at home” in California nor has claim-related contacts with California.  In other words, the thousands of plaintiffs from outside California had no business suing a New York company in California state court.

So what is a defendant to do?  This defendant removed the case to federal court, and it preserved its objections to personal jurisdiction in Answers filed upon removal.  This was clearly the correct course to take:  Removing a case to federal court does not waive any Rule 12 defenses (including lack of personal jurisdiction), and Rule 12(h) allows a defendant to preserve a personal jurisdiction defense by including it in an answer.

The cases were then transferred to multidistrict litigation, where substantial proceedings took place, including motions for summary judgment and Daubert motions.  But the drug manufacturer defendant made clear along the way that the removed cases were subject to remand motions, and it reserved its right to renew its motion for summary judgment in those cases at a later time.  (Petition at 6-8)  Eventually, the cases were remanded to the transferor district, where the Defendant again asserted its personal jurisdiction defenses and the district court acknowledged that the Defendant had not “waived any . . . defenses or arguments or issues.”  (Petition at 8)  In the end, the case was remanded to state court, then removed again, then remanded again.  (You can read our take on the last remand order and the pending Petition for Certiorari raising issues of CAFA jurisdiction here).

It is important to note that these proceedings did not occur overnight.  By the time the cases settled down in California state court, some had been pending for years.  The Defendant therefore was finally in a position to challenge personal jurisdiction, which it did by way of a motion under California procedure.  (Petition at 8-9)

And here is where things went sideways.  The California judge denied the motion and ruled that the Defendant had forfeited its personal jurisdiction defense under federal procedure because it “had more than enough time to” file a personal jurisdiction motion while it was litigating subject matter jurisdiction in federal court.  The court analogized to cases where parties litigate on the merits for multiple years and thereby waive personal jurisdiction defenses.  (Petition at 9-10)  After petitions in the California Court of Appeal and California Supreme Court were unsuccessful, the Defendant filed its Petition for Certiorari.

We think the Defendant/Petitioner has a pretty compelling case.  There is no dispute that the California courts lack personal jurisdiction.  The only issue is forfeiture, and on that point, the Petition essentially makes three points.  First, the California court cannot evade BMS v. Superior Court and due process by fashioning a “forfeiture rule” purportedly based on federal procedure that has never been recognized by any federal court.  Second, the Defendant acknowledged that failure to timely assert a personal jurisdiction defense can result in waiver, but not while litigating subject matter jurisdiction.  It is a matter of black letter law that removing a case to federal court does not constitute consent to personal jurisdiction, and litigating motions to remand following remove should not form consent either.  (Petition at 15-17)

Third, the Defendant cited the well-worn opinion in Ruhrgas AG v. Marathon Oil Co., 526 U.S. 574 (1999), which holds that subject matter jurisdiction is typically decided first, unless personal jurisdiction is also dispositive.  Because the personal jurisdiction defense applied only to the non-California plaintiffs, the Defendant had no choice but to litigate subject matter jurisdiction in the MDL.  (Petition at 20-23)  The Defendant should not be punished by risk of forfeiture for following the preferences of federal procedure.

That makes two Petitions for Certiorari raising jurisdictional issues arising from the same set of cases, and the Defendant/Petitioner has suggested that the Supreme Court consider them on the same schedule.  We will keep you posted.

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