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.

This post is from the non-Reed Smith side of the blog.

In our post earlier this week “No Causation, No ‘Parallel Claim’” we examined the enormous causation hurdle plaintiffs face in trying to prove a Stengel or Hughes type failure to warn claim in those jurisdictions where such a claim has been found not to be preempted. In that post, we commented that we “would have preferred an order finding the failure-to-warn claims preempted.” Well today, we bring you two that do just that. The first a complete preemption win, the other only a partial, but we’ll start with the good news.

Both Golden v. Brown, Case # 17CV30568, slip op. (Colo. Dist. Ct. Sep. 24, 2017) and Norabuena v. Medtronic, Inc., 2017 Ill. App. LEXIS 593 (Ill. App. Sep. 20, 2017) refused to recognize a failure to warn claim premised on a failure to report adverse events to the FDA – a Stengel claim if you’re in the Ninth Circuit and a Hughes claim if you’re in the Fifth. Now neither Colorado nor Illinois is in those circuits, but we’d like to think that regardless these state courts would have reached the same conclusion they did – neither Colorado nor Illinois law recognizes a claim for failure to warn the FDA. So, plaintiff can allege defendant violated a federal regulation by failing provide information to the FDA – but it isn’t “parallel” to any state law claim because there is no such state law claim. The Illinois appellate court summed it up nicely:

[A]lthough plaintiffs have identified a federal requirement that their complaint alleges Medtronic violated, there is no Illinois requirement that parallels it. Plaintiffs asserted claims for failure to warn. Although Illinois recognizes that a manufacturer may satisfy its duty to warn by conveying information to third-party learned intermediaries, this is not synonymous with an affirmative duty to warn a federal regulatory body. The learned intermediary doctrine states that a manufacturer has a duty to warn prescribing physicians of a drug’s known dangerous propensities” under the understanding that those physicians will use their expert knowledge in adequately warning the patient. We cannot find that this duty is parallel to the federal requirement.

Norabuena, 2017 Ill. App. LEXIS 593 at **14. The Colorado court not only found that allegations of failure to report adverse events to the FDA don’t state a parallel claim, but also concluded that Stengel and Hughes “cannot be reconciled with 21 U.S.C. §360k(a) as interpreted in Riegel or 21 U.S.C. §337(a) as interpreted in Buckman.” Golden, slip op. at 3. In other words, failure to warn a learned intermediary is different from and in addition to federal requirements regarding reporting of adverse events and a claim for failure to provide information to the FDA is an improper attempt at private enforcement of the FDCA. Just what we’ve been saying since these two awful decisions came down.

Both decisions have a little more to discuss.

In Golden, plaintiff also attempted to base a parallel claim on alleged violations of Current Good Manufacturing Processes (“CGMPs”). Noting that it was joining the majority of courts to have considered the issue, the court ruled that the CGMPs are too “vague” and “open-ended” to serve as a basis for a parallel claim. Id. at 2. The court also found plaintiff’s breach of implied warranty of merchantability claim preempted as essentially an allegation that the device was not safe and effective which would directly contradict the FDA’s PMA decision that “there is a reasonable assurance of . . . safety and effectiveness” and therefore expressly preempted. Id. at 3. And finally, the court found plaintiff’s claims impliedly preempted because plaintiff failed to explain “how Defendant’s conduct violated state law duties absent the FDCA.” Id. Simply stating that her claims were premised on Colorado common law was insufficient – “true merely in title, not substance.” Id. Instead, plaintiff’s claim exist solely under the FDCA which is not allowed.

The Golden case also suffered from some pleadings defects, such as failure to allege facts to support either a defect or causation. Id. at 2. But even if those pleading deficiencies could be cured, none of plaintiff’s claims survived preemption, so the case was dismissed in its entirety.

Switching gears to Illinois – unfortunately the court ruled that one of the bases for plaintiff’s failure to warn claim was not preempted. The FDCA contains regulations against device misbranding, which includes advertising that is false and misleading. Norabuena, 2017 Ill. App. LEXIS 593 at **15. Plaintiff alleged that defendant’s advertising was false and misleading in that it concealed known risks of using the device in an off-label manner. Id. at **16. In reaching its conclusion, the court distinguished plaintiff’s claim as not an attack on the device’s label which would be preempted as having been specifically approved by the FDA during the PMA process. But rather, plaintiff was challenging allegedly deceptive marketing practices post pre-market approval. Id. at **17. But that is a distinction without a difference where plaintiff’s allegation is that in its advertising defendant should have included a warning different from or in addition to the warning the FDA approved. The FDA-approved warning is what must accompany product advertising. Think about what the court is saying – if the warning is in the product label it must adhere to the FDA-approved language. If the warning accompanies an advertisement for the product it does not. We do not believe that is something the FDA would allow. While we can understand how a court can find that a false statement made in product promotion may be both a violation of state law and FDCA misbranding regulations, where that falsity is alleged to be a failure to include a warning not approved by the FDA, we respectfully disagree.

But, all is not lost in Norabuena. The appellate court found that plaintiff’s claims were properly dismissed on another ground – failure to plead causation. The complaint apparently was replete with allegations of “omitted” risks, “[h]owever, there are no specific factual allegations in the complaint asserting that [plaintiff’s] surgeon encountered or relied on any of the asserted promotional marketing.” Id. at **21. If a tree falls in the woods. . . . It’s not enough to plead the act or omission, the complaint was also allege facts supporting proximate cause. This pleading deficiency wasn’t enough for a dismissal with prejudice, so the case is heading back to the trial court and plaintiff will have to re-plead her remaining failure to warn claim.

We previously addressed the in pari delicto doctrine, whereby a plaintiff injured in the course of his or her criminal conduct cannot recover for those injuries.  We specifically examined this doctrine’s most common application in prescription medical product liability litigation – where the plaintiff is injured as a consequence of his or her illegal use of prescription drugs, particularly those prescribed for somebody else.

In what other situations, besides criminal activity, is plaintiff conduct going to matter to liability issues (a great variety of conduct can be relevant to damages, especially that affecting lifespan and employability) involving prescription medical products?  We recognize that, given the learned intermediary rule, the conduct of prescribing (and in some jurisdictions, treating) physicians is ordinarily going to have considerably more impact on causation issues than what plaintiffs themselves did, or didn’t do, but that said, there are situations in particular cases in which plaintiff conduct becomes especially relevant.

Plaintiff’s Comparative Fault & Contributory Negligence

In general, nothing inherent in prescription medical product liability litigation makes a plaintiff’s comparative, or where relevant contributory, negligence irrelevant.  As long as “more than a scintilla of evidence” as to comparative fault exists, the defense goes to the jury. In re C.R. Bard, Inc., 2013 WL 2431975, at *9 (S.D.W. Va. June 4, 2013) (applying Wisconsin law). See Barraza v. C.R. Bard Inc., ___ F.R.D. ___, 2017 WL 3976720, at *8 (D. Ariz. Sept. 11, 2017) (recognizing potential applicability of “assumption of the risk, or comparative or contributory negligence, as defenses” in eleven states; discussing plaintiffs who failed to comply with medical instructions).

of Judge Posner, in Robinson v. McNeil Consumer Healthcare, 615 F.3d 861 (7th Cir. 2010) (applying Virginia law), affirmed a defense verdict on contributory negligence where the plaintiff “didn’t sue [her doctor] for malpractice, and she doesn’t argue that it was reasonable for her (and therefore not contributorily negligent) to rely on the doctor’s failure to warn her.”  Id. at 870.  In Craft v. Peebles, 893 P.2d 138 (Haw. 1995), the defendant was entitled to assert the plaintiff’s failure to stop smoking as contributory negligence.

However, the contributory negligence instruction was appropriate with respect to [the defendant manufacturer] because the evidence presented at trial raised a bona fide issue with respect to [plaintiff’s] alleged contributory negligence.  The record indicates that . . . she smoked a pack of cigarettes a day and that she had been smoking for seventeen years.  [Plaintiff’s] expert . . . testified that [her symptoms] could have resulted from the cigarettes.

Id. at 154.  In the same vein, in Rosa v. Medtronic MiniMed, Inc., 2008 WL 1990892 (D.P.R. May 6, 2008), the plaintiff’s “failure to adequately monitor his glucose levels and take the necessary measures in response,” presented a jury question, notwithstanding plaintiff’s blaming his actions on bad advice from his treating physician. Id. at *7-8.  Conversely, because the defendant failed to develop the necessary expert testimony to support causation-based defenses of comparative negligence, plaintiff misconduct, apportionment of liability, and superseding/intervening cause – but only because of that failure – in Bartlett v. Mutual Pharmaceutical Co., 731 F. Supp.2d 184, 188-191 (D.N.H. 2010), the plaintiff was successful in removing those defenses from the case.  So, where supported by sufficient evidence defenses based on plaintiff conduct are available in pharmaceutical product liability litigation.

Plaintiff’s Failure To Read Relevant Warnings

The most common way to defeat causation in a prescription medical product case with plaintiff-specific evidence is when that evidence establishes that the plaintiff did not read available information about serious risks.  We’ve discussed at length how this argument works when the prescribing physician fails to read warnings, and the principle is the same when the plaintiffs themselves are at fault.  Several state appellate courts have so held.  Most of these cases involve situations where, for one reason or  another, the learned intermediary rule is inapplicable.  In an OTC drug case, the California Supreme Court held:

Plaintiff’s mother, who administered the [product] to plaintiff, neither read nor obtained translation of the product labeling.  Thus, there is no conceivable causal connection between the representations or omissions that accompanied the product and plaintiff’s injury.

Ramirez v. Plough, Inc., 863 P.2d 167, 177 (Cal. 1993).  Along the same lines is E.R. Squibb & Sons, Inc. v. Cox, 477 So. 2d 963, 971 (Ala. 1985), holding:

The evidence is undisputed that plaintiff did not read any of the instructions or warnings [defendant] provided on and with its [product]. . . .  Even if the warning accompanying this [product] had read, [extremely graphic warning omitted], it would not have altered this plaintiff’s course of action and prevented his injury, because he would not have read it.  [Defendant’s] inadequate warning, therefore, did not cause plaintiff’s injury.

Id. at 971.  Accord Moore v. Vanderloo, 386 N.W.2d 108, 112 (Iowa 1986) (summary judgment affirmed where “[t]here is no evidence under this record that [plaintiff] read or relied on any of [defendant’s] informational material”); Prince v. B.F. Ascher Co., 90 P.3d 1020, 1027 (Okla. Civ. App. 2004) (“[m]anufacturers, however, are not required to foresee that consumers will fail to read the product’s warnings and then use the product in a manner that the instructions expressly warn against”); Mulhall v. Hannafin, 841 N.Y.S.2d 282, 287 (N.Y. App. Div. 2007) (summary judgment affirmed; plaintiff testified that she “chose not to read the consent forms warning against the risks [in question] and even death, and signed them nonetheless”); Sosna v. American Home Products, 748 N.Y.S.2d 548, 549-50 (N.Y. App. Div. 2002) (summary judgment affirmed where “plaintiff’s deposition testimony was clear that he had not read defendant manufacturer’s warnings until after he had stopped using its product and sustained the complained-of injury”).

In another OTC drug case, the aforementioned, Robinson v. McNeil decision also relied on the plaintiff’s failure to read warnings in affirming a defense verdict:

[Plaintiff] didn’t read or remember the warnings before taking the [drug], so it wouldn’t matter what the label had said unless it had contained truly terrifying warnings that the state of medical knowledge would not have justified.

615 F.3d at 870.  Accord Boruski v. United States, 803 F.2d 1421, 1426, 1429 (7th Cir. 1986) (“had [plaintiff] read what the form says about risks and the particular disease she claims to have contracted, she would have found the form clearly sufficient in its warning”) (applying Illinois law).

In Sparks v. Oxy-Health, LLC, 134 F. Supp.3d 961 (E.D.N.C. 2015), plaintiffs bought a action about a home-use medical device, but none of them “ever read the instruction manual that came with the [device] when it was purchased.  Id. at 994.  Plaintiffs’ conduct required summary judgment against their warning claims:

because the [plaintiff] family did not read the Reference Manual or follow existing warnings, and because there is no credible evidence to suggest an on-[product] warning would have changed [their] behavior, plaintiffs cannot establish causation as a matter of law. . . .  Of particular importance is the [plaintiff] family’s collective failure to read the Reference Manual provided with the [device].

Id. at 995.  Similarly, the court in Walker v. Merck & Co., 648 F. Supp. 931, 935-36 (M.D. Ga. 1986), held:

Manufacturers are not insurers, and a manufacturer cannot be held liable for a consumer’s failure to read or to listen to understandable warnings.  Even taking as true [plaintiff’s] allegation that she does not remember being asked about the [risk], the fact remains that [she] and her mother were provided with a form delineating the risks inherent in [the product] while they were waiting in line for [her] to be vaccinated.  [Defendant] used all reasonable care required by law to warn of potential injury.

Id. at 935-36.

Not all the cases are when the learned intermediary rule is inapplicable.  Some involve supplemental patient-directed information.  For example, “[a]s Defendants point out, there is no evidence the alleged inadequate warning was the proximate cause of [plaintiff’s] injury.  The record is clear Plaintiffs failed to read the detailed patient labeling, which explicitly warned of the precise injury that resulted.”  Canady v. Ortho-McNeil Pharmaceutical, Inc., 2014 WL 4930675, at *3 (N.D. Ohio Oct. 1, 2014) (applying Oregon law).  Accord Shah v. Forest Laboratories, Inc., 2015 WL 3396813, at *9 (N.D. Ill. May 26, 2015) (summary judgment granted where “there is absolutely no evidence that [plaintiff] ever read the [disputed] Brochure”); Scharff v. Wyeth, 2011 WL 3320501, at *14 (M.D. Ala. Aug. 2, 2011) (plaintiff “testified that though she might have glanced at the . . . Patient Information Insert, she did not read it”); Crayton v. Rochester Medical Corp., 2011 WL 475009, at *13 (E.D. Cal. Feb. 4, 2011) (“[n]o matter what the “Instruction for Use Sheet” would have said, based on Plaintiff’s representations, he would never have seen it”), aff’d, 548 F. Appx. 483 (9th Cir. 2013); McSwain v. Sunrise Medical, Inc., 689 F. Supp.2d 835, 844 (S.D. Miss. 2010) (plaintiff “cannot prove that the manual’s inadequate warnings proximately caused his injury because [he] voluntarily made the decision to not read the manual”); Gibson v. Sanofi-Aventis U.S., LLC, 2009 WL 3490454, at *5 (W.D. Ky. Oct. 27, 2009) (plaintiff “testified that she did not read any product materials which accompanied her [drug] prescription”); Dyson v. Winfield, 113 F. Supp.2d 35, 41 n.3 (D.D.C. 2000) (“by plaintiff’s uncontradicted testimony, she did not read the warning”; “an unread warning cannot serve as a basis for a claim that the warning affected one’s behavior”), aff’d mem. 21 Fed. Appx. 2 (D.C. Cir. 2001); Cornelison v. Tambrands, Inc., 710 F. Supp. 706, 711 (D. Minn. 1989) (plaintiff “fail[ed] to show the existence of a material factual dispute because there is no evidence that [she] used [product] from boxes which contained the labels”); Ortolano v. BDI Marketing, 2005 WL 4889720 (La. Dist. April 21, 2005) (plaintiff “admitted . . . that he did not read the entire label”; his “failure to warn claim must fail because it could not have possibly been the proximate cause”).

For awhile, West Virginia rejected the learned intermediary rule.  That ruling didn’t actually help plaintiffs all that much, since most of them actually did engage in the conduct on which the rule is predicated – they in fact relied on their prescribers (as the rule posits) and thus didn’t read the allegedly defective drug warnings themselves.  That failure meant West Virginia plaintiffs still lost on the issue of causation.  See Meade v. Parsley, 2010 WL 4909435, at *9 (S.D.W. Va. Nov. 24, 2010) (plaintiff “testified that she never read [defendant’s] package insert or any other documents accompanying her . . . prescription); In re Zyprexa Products Liability Litigation, 2009 WL 1514628, at *12 (E.D.N.Y. June 1, 2009) (“no evidence that [plaintiff] ever read any of defendant’s warnings”) (applying West Virginia law).

The heeding presumption can also be defeated by plaintiff failure to read.  Precisely that supported a defense verdict in Gaghan v. Hoffman-La Roche, Inc., 2014 WL 3798338, at *7 (New Jersey Super. App. Div. Aug. 4, 2014), where neither plaintiff nor her mother “read the warning material that was provided to them, thus suggesting that a more strongly-worded warning would not have been heeded.” Id. at *7.  Likewise, in In re Prempro Products Liability Litigation, 514 F.3d 825, 829 (8th Cir. 2008) (applying Arkansas law), it was proper to instruct the jury under Arkansas law that the defendant was justified in assuming that the plaintiff would read an available warning where plaintiff “admi[tted] that she never read the warnings [defendant] included.”  See Seley v. G.D. Searle & Co., 423 N.E.2d 831, 839 (Ohio 1981) (plaintiff’s failure to inform prescriber of prior medical history defeated heeding presumption).

Plaintiff’s failure to read – or lack of exposure to – direct to consumer information has also been successful in defeating warning claims, whether or not (mostly “not”) courts have allowed this purported exception to the learned intermediary rule. See Ramirez, 863 P.3d at 177 (“plaintiff’s mother could not have relied upon defendant’s advertising because she admittedly did not see or hear it”); In re Norplant Contraceptive Products Liability Litigation, 165 F.3d 374, 379 (5th Cir. 1999) (no evidence that plaintiffs “actually saw, let alone relied, on any marketing materials issued” by defendant) (applying Texas law); Mendez Montes De Oca v. Aventis Pharma, 579 F. Supp. 2d 222, 230 (D.P.R. 2008) (“none indicate that decedent was privy to this informational material prior” to use).

Plaintiff’s Failure To Follow Relevant Warnings

Another recurring way to defeat causation is to establish that the plaintiff in fact received an adequate warning about the risk(s) in question and nevertheless used the product and suffered from the warned-of risks. The Texas Supreme Court considered this type of evidence in holding in Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012), that plaintiffs had failed to establish causation:

[The prescriber] specifically warned [plaintiff] that she might have [the adverse event at issue], but despite this warning, [plaintiff] chose to continue receiving [the drug] and [the prescriber] continued prescribing them to her.  [Plaintiff’s] actions indicate that, even if [defendant] provided a different warning to her doctors, she would likely have continued [the drug] for her serious medical condition despite the risk. . . .  [Plaintiff] was also aware of other potentially serious, yet rare, side effects from [the drug], such as cancer, but chose to take the drug anyway.

Id. at 172-73.

A plaintiff’s outright disregard of relevant warnings is, of course, the most persuasive form that this type of evidence can take. Thus, in Broussard v. Procter & Gamble Co., 517 F.3d 767 (5th Cir. 2008), the plaintiff “violated extensive warnings when she used” the medical device at issue.  Id. at 770.  Under Louisiana law “plaintiffs who used a product in a manner that violates clear and express warnings can show that their use was reasonably anticipated only by presenting evidence that the manufacturer had reason to know that these warnings were ineffectual,” as to which she suffered summary judgment by “fail[ing] to present even one scintilla of evidence.” Id.

Likewise, in Bock v. Novartis Pharmaceuticals Corp., 661 Fed. Appx. 227 (3d Cir. 2016) (applying Pennsylvania law), summary judgment was affirmed where,

the evidence mustered paints the opposite picture [from what plaintiff needed], particularly the fact that [plaintiff], though informed by [his prescriber] of the risks of dental procedures and the concomitant need to inform his doctor of the need for any dental work, scheduled tooth extractions without consulting [his doctor].

Id. at 232-33.  The Sparks case, cited above, also involved the plaintiffs “fail[ing] to follow a pre-existing on-chamber warning.”  134 F. Supp.3d at 994.  So did Kelley v. Unico Holdings, Inc., 2009 WL 6316398 (Mag. S.D. Ohio July 16, 2009), adopted, 2010 WL 1267375 (S.D. Ohio March 29, 2010), since the plaintiff took “twice the daily dose” in the face of label warnings that “exceeding the recommended dose . . . can be harmful.”  Id. at *6.  Accord Crayton, 2011 WL 475009, at *13 (“Plaintiff was aware there was [a condition] in the [product] that could be painful for him to use [it], but he continued to use”); In re NuvaRing Litigation, 2013 WL 1874321, at *24 (N.J. Super. Law Div. April 18, 2013) (plaintiff “should have consulted her doctor as advised by the label”).

On similar evidence, a heeding presumption-based claim was defeated in D’Agnese v. Novartis Pharmaceuticals Corp., 952 F. Supp.2d 880 (D. Ariz. 2013):

Moreover, even after being warned of the possible risk . . ., [plaintiff] continued to take [the drug]. This would permit reasonable minds to conclude that [plaintiff’s] original prescribing doctor would have nonetheless prescribed [the drug] to [plaintiff] and/or that [his risk] would not have been averted.

Id. at 892-93 (footnote omitted).  Likewise, the plaintiff lost in In re Zyprexa Products Liability Litigation, 2009 WL 5216930 (E.D.N.Y. Dec. 21, 2009) (applying Minnesota law), where his prescriber “herself provided comprehensive warnings to the patient about [the drug’s]  association with” relevant risks. Id. at *12.  Thereafter, the plaintiff “elected to continue treatment with [the drug] for nearly three years after being diagnosed with [the risk], despite having been counseled that [these risks] are potential side effects of the medication.”  Id.  See In re Zyprexa Products Liability Litigation, 2009 WL 5062114, at *14 (E.D.N.Y. Dec. 10, 2009) (prescriber “counselled plaintiff on the need for close monitoring”), aff’d, 394 F. Appx. 814 (2d Cir. 2010) (applying California law); Harrington v. Biomet, Inc., 2008 WL 2329132, at *6 (W.D. Okla. June 3, 2008) (“Plaintiff was advised both before and after surgery and repeatedly thereafter of the risk . . . and what precautions to take”); In re Accutane Litigation, 2016 WL 5958375, at *16 (New Jersey Super. Law. Div. Oct. 12, 2016) (granting summary judgment where plaintiff testified “that he would have taken [the drug] regardless of his receiving [risk] warnings”) (applying Colorado law); id. at *30 (same where plaintiff admitted she “would have allowed” the drug where “the doctor felt that the benefits outweighed the risks”) (applying Nebraska law); In re Alloderm Litigation, 2015 WL 5022599, at *10 (New Jersey Super. Law Div. Aug. 14, 2015) (admitting testimony that plaintiff’s injury stemmed from activity that plaintiff “was advised repeatedly by medical professionals to limit or reduce”).

In Muzichuck v. Forest Laboratories, Inc., 2015 WL 235226, at *13 (N.D.W. Va. Jan. 16, 2015), summary judgment was granted where the warning in question came directly from the defendant, not the plaintiff’s prescriber.  The warning was “adequate,” and “uncontroverted facts establish that [plaintiff’s decedent] actually read the warning from the package insert.” Id. at *13.  Similarly, Niedner v. Ortho-McNeil Pharmaceutical, Inc., 58 N.E.3d 1080, 1086 (Mass. App. 2016), involved an exception to the learned intermediary rule, with the same result, since the warning was adequate as a matter of law:

As a matter of law, the insert adequately warned [plaintiff] of the increased risk . . . that could result in death, as compared to the risks associated with the [alternative], in terms understandable to a lay person. . . .  Here, the insert was abundant in its warning of the possibility [the risk] that could lead to death.

Id. at 1086 (citations omitted).

Note: there is another subset of cases of this type, involving off-label use where no manufacturer promotion occurred, that could fit here, but those cases have somewhat different implications, and since this post is getting long already, we will leave them for another day.

Plaintiff’s Informed Consent Forms as a Source of Risk Knowledge

Evidence of what a plaintiff “was told regarding the risk . . . and what [the] response was to that knowledge” is admissible concerning causation, E.R.G. v. Abbott Laboratories, Inc., 2017 WL 2126837, at *2 (S.D. Ill. May 16, 2017) (applying California law); see Newman v. McNeil Consumer Healthcare, 2013 WL 7217197, at *17 (N.D. Ill. Mar. 29, 2013) (contents of OTC drug label that plaintiffs read sufficient to create jury question as to assumption of the risk).   Besides the label itself, one good place to look for such evidence are informed consent forms signed by plaintiff or a relevant guardian.  Such forms can controvert a plaintiff’s denials of being warned (defeat plaintiff’s burden) or even constitute assumption of the risk (meet defendant’s burden).  As mentioned above, the evidence that defeated the heeding presumption in D’Agnese came from an informed consent form.  952 F. Supp.2d at 892 n.10.

In In re C.R. Bard, Inc., 2013 WL 5591948, at *8 (S.D.W. Va. June 4, 2013) (applying Mississippi law), and C.R. Bard, 2013 WL 2431975, at *9 (applying Wisconsin law), information from plaintiff informed consent forms were held relevant and admissible “to whether [the plaintiff] understood and assumed the risk of having the defective . . . product implanted in her.”

[Defendant] has provided some evidence that [plaintiff] was advised of the risks and consented to the implantation of the . . . products anyway.  Accordingly, even if the court or jury found that the . . . product was, in fact, defective, there would be a genuine issue of material fact as to whether . . . knew and understood of the defects and nonetheless consented.

2013 WL 5591948, at *8; accord 2013 WL 2431975, at *9.  See Taylor v. Pharmacia-Upjohn Co., 2005 WL 3502052, at *5 & n.9 (S.D. Miss. Dec. 19, 2005) (informed consent form established that plaintiffs had in fact received warnings); McMurdie v. Wyeth, 71 Pa. D. & C.4th 225, 230-35 (Pa. C.P. 2005) (extensive “on record” informed consent discussions established that plaintiff “knowingly and voluntarily assumed these risks”) (applying Utah law).

Plaintiff’s Failure To Offer Affirmative Testimony

We’ve already discussed how the burden of proof in a learned intermediary case mandates summary judgment where the plaintiff fails to obtain testimony from the prescribing physician(s) that a different warning would have changed the outcome in some relevant way.  Well, the same result can occur when a plaintiff does not provide his or her own affirmative causation testimony – which, believe it or not, does happen sometimes.  The plaintiff’s testimony in Georges v. Novartis Pharmaceuticals Corp., 988 F. Supp.2d 1152, 1157-1158 (C.D. Cal. 2013), failed to establish causation on a theory that she “would have ignored [her prescriber’s] advice and declined the Treatment Drugs after being warned of the risk when she was first offered them.”  Id. at 1158.  All plaintiff established was “that she would have stopped taking them after [her] symptoms . . . first arose.”  Id.  Likewise, in Hanson v. Boston Scientific Corp., 2016 WL 1448868 (S.D.W. Va. April 12, 2016) (applying Wisconsin law), the plaintiff tried to have it both ways on the learned intermediary rule, but instead lost both.  As to the plaintiff, Hanson held:

[T]he plaintiff still has not provided evidence of causation.  In fact, despite arguing against the application of the learned intermediary doctrine in her response, [plaintiff] provides no evidence that she − instead of [her prescriber] − would have rejected implantation had she known of the warning’s alleged insufficiency.

Id. at *5.  See In re Accutane Litigation, 2016 WL 5958375, at *42 (New Jersey Super. Law. Div. Oct. 12, 2016) (“Summary Judgment must be granted even under Plaintiff’s own standard where Plaintiff’s decision maker did not testify that she would not have allowed her daughter to take [the drug] in the face of an allegedly stronger warning) (applying Ohio law); id. at 48 (similar ruling under Wisconsin law).

Plaintiff’s Failure To Disclose Critical Medical Information

Another way in which plaintiff conduct can defeat causation is when the plaintiff fails to inform his or her prescriber of critical medical history necessary to an accurate assessment of medical risk.  Way back in 1975 the Oregon Supreme Court ruled in Vaughn v G.D. Searle & Co., 536 P.2d 1247 (Or. 1975), that the plaintiff’s failure to inform her treating physicians of “premonitory symptoms of a stroke prior to or at the time she saw” them defeated causation. Id. at 1249.

We find that plaintiff has offered no evidence, either direct or indirect, that she ever advised her treating physicians of symptoms which would have alerted them to the possibility of a stroke.  Without such knowledge there was no way the physician could have related any warning (that there is a cause-and-effect relationship between the ingestion of the drug and a stroke) to plaintiff’s particular case.  Thus, there was no evidence that even a properly warned physician would have treated plaintiff differently or removed her from defendant’s [product] prior to her stroke.

Id. at 1249-50.  Therefore, “there was no evidence that any failure to warn plaintiff’s physicians was a substantial factor in producing plaintiff’s injuries and that defendant’s motion for a directed verdict should have been granted.”  Id. at 1251.

The Ohio Supreme Court came to the same conclusion in Seley, 423 N.E.2d at 838-39, where the plaintiff asserted that the defendant “failed to warn that women with a prior history” of a particular condition “were subject to a higher risk” when using the drug.  Id. at 838.  Plaintiff, however, had “failed to disclose to [her prescriber] that she had experienced” that condition.  Id.  Thus, even “an adequate warning would have made no difference” to the prescriber, misled by the plaintiff’s non-disclosure.  Id. See  Kurer v. Parke, Davis & Co., 679 N.W.2d 867, 878-79 (Wis. App. 2004) (summary judgment affirmed; “when [plaintiff] suffered her symptoms, her patient insert advised her to call her doctor,” but “she did not call her doctor as the patient insert instructed”); Brown v. Glaxo, Inc., 790 So.2d 35, 42 (La. App. 2000) (plaintiff did “not report[] the increasingly severe side effects” from the drug to her prescriber and was therefore “negligent”); Dyer v. Best Pharmacal, 577 P.2d 1084, 1088 (Ariz. App. 1978) (“Just as a drug manufacturer cannot be required to foresee a physician’s negligence, neither can it be required to foresee that a patient might mislead a physician about her physical condition in order to obtain a prescription drug”); Parkinson v. Novartis Pharmaceuticals Corp., 5 F. Supp.3d 1265, 1275 (D. Or. 2014) (following Vaughn; summary judgment granted where “Plaintiff failed to advise any of her dental-treatment providers until after both of her teeth had been extracted” about her use of defendant’s drug); Davids v. Novartis Pharmaceuticals Corp., 857 F. Supp.2d 267, 287 (E.D.N.Y. 2012) (granting summary judgment where treater “testified that the Plaintiff did not disclose that she was taking [the drug], or any other [similar] drug, until after she allegedly developed” the complained of condition); Dyson, 113 F. Supp.2d at 41 (summary judgment granted; where plaintiff did not inform prescriber of pregnancy, no better birth defect warning would make any difference).

Plaintiff’s Noncompliance With Medical Instructions

A plaintiff’s non-compliance with his or her physician’s affirmative medical instructions is also fair game.  In Zyprexa, 2009 WL 5062114, defendant was entitled to summary judgment, inter alia, where the “it was well documented throughout plaintiff’s medical records that she was non-compliant with [risk] treatment and diet since the time of her diagnosis.”  Id. at *14.  In Gross v. Stryker Corp., 858 F. Supp.2d 466 (W.D. Pa. 2012), the defendant successfully asserted the plaintiff’s comparative fault in “improperly caring for his incision” and not “adhering to a prescribed rehabilitation regimen” to preclude plaintiff’s reliance on res ipsa loquitur.  Id. at 499.  Previously, in the same court, comparative fault likewise applied to the plaintiff’s failure to follow his drug treatment regimen in Purnell v. United States, 1987 WL 11211, at *6 (E.D. Pa. May 21, 1987).  Similarly, in Emody v. Medtronic, Inc., 238 F. Supp.2d 1291 (N.D. Ala. 2003), the plaintiff’s failure to return for several medical appointments raised “a matter of legitimate dispute” over “[w]hether this [conduct] constituted contributory negligence” as a matter of law.  Id. at 1294.  In Barraza, 2017 WL 3976720, at *8, plaintiffs’ non-compliance, including one who “ignored no less than five letters from her implanting physician requesting clinical follow-up” were cited as examples of possible comparative fault in denying class certification.

Miscellaneous Relevant Plaintiff-Related Evidence

Plaintiff conduct has also been admitted as evidence allowed in various other contexts. In Gaghan, such testimony encouraged a jury to disbelieve the usual plaintiff “I wouldn’t have used, had I only known” testimony:

There was substantial evidence from which the jury could have found that [plaintiff] would have taken [the drug] even if [the prescriber] had received and passed on to her and her mother a stronger warning in the form recommended by plaintiffs’ expert witnesses.  [Plaintiff mother] testified that her daughter was upset and embarrassed . . ., disgusted with the way she looked, and becoming socially withdrawn.  The mother was very concerned about the detrimental physical and emotional effect [this] was having on her daughter.

2014 WL 3798338, at *7.

Plaintiffs who are also physicians in their own right lose when they don’t act like the professionals they’re supposed to be.  The plaintiff-physician in Wolfgruber v. Upjohn Co., 72 A.D.2d 59, 423 N.Y.S.2d 95 (N.Y. App. Div. 1979), aff’d, 52 N.Y.2d 768, 417 N.E.2d 1002, 436 N.Y.S.2d 614 (1980), lost because he “knew the risks of taking this particular drug whose side effects were those specifically warned against.”  Id. at 97.  In Herzog v. Arthrocare Corp., 2003 WL 1785795 (D. Me. March 21, 2003), the plaintiff, also a physician, had used the defendant’s medical device himself when performing surgery, and therefore “a jury might conclude that [plaintiff] should have known that [his surgeon] might use the” device in a particular way and “therefore, he unreasonably proceeded to encounter a danger that was known to him.”  Id. at *17.

Where the plaintiff continued using the same drug, or continued having the same symptoms after ceasing use of the drug also “undermine[s]” the causation element.  Taylor, 2005 WL 3502052, at *5 n.9 (plaintiffs’ resumed use of the product indicated no warning would have deterred them).  See Richardson v. GlaxoSmithKline, 412 F. Supp.2d 863, 867 (W.D. Tenn. 2006) (summary judgment granted where plaintiff made multiple suicide attempts before and after using drug).

In Roberts v. Albertson’s LLC, 464 F. Appx. 605 (9th Cir. 2011) (applying Nevada law), causation was not established where plaintiff “did not present any evidence that it would have been foreseeable that the defect would cause him to stop taking his medication” altogether, so that no defect could have been “a substantial factor in causing [plaintiff’s] injury.”  Id. at 608.

In Carey v. Shiley, Inc., 32 F. Supp.2d 1093, 1099-1100 (S.D. Iowa 1998), causation was not proven where plaintiff’s “physicians agreed that the [procedure] was necessary regardless of the need for the [product] explant,” so the later explant was inevitable.

Finally, plaintiff misconduct, leading to “sexually transmitted diseases” in Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1162 (D. Or. 1989), and to suicide in Rimbert v. Eli Lilly & Co., 577 F. Supp.2d 1174, 1233 (D.N.M. 2008), have also been considered relevant in particular situations, irrespective of labeling.

Not even three weeks ago, back on July 28,  we discussed the court’s rigorous application of Daubert in excluding expert medical causation opinions in Smith v. Terumo Cardiovascular Sys. Corp., a federal case in the district of Utah.  The plaintiff had undergone a heart valve replacement surgery.  As is typical, the surgery required use of a perfusion heart/lung bypass machine.  At some point, the machine stopped working for 10-11 minutes.  The patient died of a heart attack 11 months later.    The decedent’s heirs brought suit against various defendants, including the manufacturer of the heart/lung bypass machine.

 

In the opinion we discussed on July 28, the court excluded most of the opinions of a cardiologist tendered by plaintiffs as an expert on causation.  That expert was refreshingly candid in acknowledging that he could not say for sure that the heart attack was caused by any machine malfunction, though he thought the malfunction probably played some role.  Because the cardiology expert himself acknowledged an “analytical gap,” because he was plainly unqualified to render opinions on neurologic issues, and because he relied on diagnostic methods that were not generally accepted, the court limited the cardiologist expert’s testimony to an opinion that the decedent’s heart was injured during the valve replacement surgery.  Not nothing, but not much, either. 

 

Today, we discuss the same litigation with the same Daubert issue with a different expert but a similar result.  Smith v. Terumo Cardiovascular Sys. Corp., 2017 U.S. Dist. LEXIS 124866 (D. Utah August 7, 2017), involves a different plaintiff expert proffered to opine on medical causation.  This expert was a licensed perfusionist.  No one disputed that this expert could opine on the standard of care applicable to perfusionists and facilities where perfusion services are offered.  What was disputed was whether the expert could testify about a potential defect in the heart/lung bypass machine that may or may not have exhibited during the surgery in question.  The expert was going to testify that a defect in the machine’s air bubble detection system led to the inadvertent 10-11 minute shutdown during the surgery.  The expert primarily relied upon a recall of the heart/lung bypass machine that occurred almost two years after the decedent’s surgery.

 

The court begins its analysis in the right place with Federal Rule of Evidence 702.  Then we get a paragraph on how the law favors admissibility of expert testimony.  We wince whenever we read about such a presumption, anticipating judicial abdication of the gatekeeping function.  But that was not the case here.  Rather, the court carefully assessed the expert’s qualifications and found them wanting.  The expert knew all about perfusion and how to operate the heart/lung bypass machine, but that does mean he possessed the requisite expertise to analyze the design and technical functionality of the machine.  The defense deposed the expert, and did a nice job of bringing out the expert’s lack of expertise in mechanical engineering or design.  The existence of the product recall might have been suggestive, but to explain why the recall was issued, and why the reason for the recall also accounted for the device’s stoppage during the surgery, required precisely the sort of engineering or design expertise that was lacking.

 

Even aside from the threshold issue of qualifications, the court concluded that the expert’s opinions were unreliable.  The expert’s report disclosed reliance on depositions, reports, system logs, and medical records.  That sounds pretty good.  But the expert never explained how the facts he reviewed, including the device recall, added up to a defect in the device that prompted the stoppage during the surgery. The expert theorized that the perfusion system might have issued a false alarm, which then resulted in the stoppage, but nothing concrete supported that theory.  Indeed, the expert admitted in deposition that no one could explain exactly how the alleged malfunction occurred.   (More refreshing candor!) The court seized upon something that plaintiffs usually emphasize: the failure to test.  The plaintiff’s expert had never attempted to test his defect theory.  Testing, of course, is one of the key Daubert factors.  In this case, the expert’s failure to test his theory kept him in the realm of speculation, and kept his opinions away from the jury.

 

 

 

 

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

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

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

  1.  Motion for Judgment as a Matter of Law

                        Adequacy of Label Warnings

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

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

            Warnings Causation 

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

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

  1.  Motion for New Trial 

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

Mother’s Testimony

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

“Top 3” Opinion 

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

Improper Comments in Plaintiff’s Closing Argument 

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

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

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

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

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

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

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

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

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

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

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

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

Today we feature another guest post from our European correspondents, Reed Smith partner Marilyn Moberg and associate Kathryn Bond.  There has been another significant decision from the Court of Justice (its description, not ours) of the European Union, and once again it is bad news for manufacturers of life-saving prescription products – this time vaccines.  Without stealing our guest bloggers’ thunder, let’s just say that the European attitude appears to be “Daubert?  We don’t need no stinkin’ Daubert.”  For the details, see below.  As always our guest bloggers deserve 100% of the credit (and any blame) for what they write.

***********

Bonjour à tous.

Now that we have completely exhausted our entire high school French vocabulary, for today’s blog post we are traveling back across the Atlantic to France and Luxembourg. Today, we examine a recent judgment of the Court of Justice of the European Union relating to the evidentiary requirements for finding a causal link between a vaccine and an unrelated disease where there is no medical proof to support the existence of such a causal link. For our American readers who are familiar with the way vaccine cases used to be litigated, one may get a feeling of “déja vu,” and not in a good way.

If we cast our minds back to the 1980s scare over the DPT vaccine, large jury awards were given to plaintiffs despite the fact that most public health officials did not believe that there was a link between the vaccine and certain autism spectrum disorders. As a result of these cases, a number of vaccine makers decided to cease production. For the United States government, this development was worrying and threatened a drop in important childhood vaccinations. In order to encourage the continued production of vaccines, Congress passed the National Childhood Vaccine Injury Act, which set up the National Vaccine Injury Compensation Program (NVICP) in 1988 to compensate individuals (or their families) allegedly injured by certain covered childhood vaccines. The compensation scheme is funded by a tax on vaccines purchased. The scheme applies only to conditions that have already been determined administratively to be associated with the vaccine, therefore relieving (i) the plaintiff of the burden of proving a general causal link between the vaccine and the injury; and (ii) the vaccine producer of the cost of defending or settling expensive civil liability cases. The plaintiff is still required to prove that, on balance, a specific causal link between the vaccine and the injury. Although this scheme is limited to certain injuries caused by certain vaccines, it significantly reduced the number of product liability claims against manufacturers for vaccines. See generally Bruesewitz v. Wyeth LLC, 562 U.S. 223, 226-30 (2011) (describing NVICP and reasons for its enactment).

Now, back to the case at hand, which is Case C-621/15, N.W. and Others v Sanofi Pasteur MSD and Others (NW v Sanofi). The judgment has been widely reported as particularly favorable for claimants because it confirms that a claimant can establish, despite total lack of individualized corroborating medical evidence, a causal link between the vaccine and the disease where there is “serious, specific and consistent evidence” that a causal link exists.

By way of background, EU law on product liability is set out in the Product Liability Directive 85/374/EEC. Article 4 of the Directive stipulates that, in order to win a product liability claim, the claimant must prove the damage, the defect and the causal relationship between the defect and the damage. In other words, and unsurprisingly, the burden of proof is on the injured party.

In the NW v Sanofi case, NW developed multiple sclerosis a short period after being vaccinated against Hepatitis B. Although medical research has not established a connection between the Hepatitis B vaccine and multiple sclerosis, the claimant sought to rely on a provision of French case law of the Cour de Cassation (the highest French court). The case law provides that, in relation to the liability of producers of vaccines, proof of a causal link can be derived from “serious, specific and consistent presumptions” in the absence of medical research. The claimant believed that, on the basis of this case law, the French courts could take into account the following facts to find a “lien de causalité” or “causal link”: (1) the short time lapse between the administration of the vaccine and the onset of the disease; and (2) the patient’s lack of any personal or family history of the disease. Essentially, any product manufacturer becomes an insurer against any qualifying medical condition that might manifest itself during this short time lapse, regardless of scientific basis.

At first instance, the Tribunal de Grande Instance in Nanterre, France, found in favour of the claimant, but the decision was subsequently overturned on appeal by the Cour d’Appel in Versailles, France and the Cour d’Appel in Paris, France. When the case finally reached the Cour de Cassation, the judges faced some difficult questions concerning the compatibility of its case law with Article 4 of the Product Liability Directive. In particular, does Article 4 override France’s own national rules regarding the level of proof required to find a causal link between the defect and the damage? This was clearly a question of interpretation of EU law. The Cour de Cassation therefore referred this question to the Court of Justice of the European Union (“CJEU”) for a preliminary ruling.

For those (most) of you not familiar with EU procedural law, here is some important background. The CJEU is based in Luxembourg and is the highest court of the European Union. The CJEU plays an important role in the EU, which includes interpreting EU law to make sure it is applied in the same way across all 28 (soon to be 27) Member States. One of the ways in which the CJEU achieves this is through the “renvoi préjudiciel” or “reference for a preliminary ruling,” which bears some resemblance to the American procedure of federal courts certifying state-law questions to state high courts for resolution. This procedure enables the courts of each Member State to refer questions to the CJEU for a ruling on the interpretation of a specific point of EU law. When the CJEU gives its ruling, its sole mandate is to rule on the point of EU law in question only.

In the case of NW v Sanofi, the CJEU considered the following points:

Whether Article 4 precludes the French Courts from considering its own national evidentiary rules (including those described above), in circumstances where medical research has not established a causal link between the administering of the vaccine and the disease, when determining whether there is a defect in the vaccine and whether there is a causal link between that defect and the disease?

In response to this question, the CJEU gave the following analysis at paras [18]-[43]:

  1. It is ultimately the injured party’s responsibility to prove the damage, the defect and the causal relationship between the defect and the damage (para [19]).
  2. The Product Liability Directive does not contain any definition of the concept of “causal relationship” for the purposes of Article 4 (para [22]). This means that, taking into account the principle of procedural autonomy of each Member State, it is for each Member State to establish:
    1. the way in which evidence is to be provided;
    2. what evidence is admissible;
    3. the principles governing the national court’s assessment of the evidence; and
    4. the level of proof required (para [25]).
  3. The national court’s procedural autonomy should not, however, undermine the effectiveness of EU procedural rules. For example, the national rules should not bring about a reversal of the burden of proof set out in Article 4 of the Product Liability Directive (paras [26]-[27]).
  4. The national courts must ensure that the evidence provided is sufficiently serious, specific and consistent to warrant the conclusion that, notwithstanding the evidence produced by the producer, a defect in the product appears to be the most plausible explanation for the occurrence of the damage, with the result that the defect and the causal link may reasonably be considered to be established (see para [37]).
  5. Although the CJEU is not mandated to apply EU law to the facts of a specific case, the CJEU commented that facts such as:
    1. a short time lapse between the administration of the vaccine and the occurrence of the disease;
    2. the existence of a significant number of reported cases of the disease occurring following such vaccines being administered; and
    3. a lack of personal and familial history of the disease,Based on the above analysis, the answer to the question was a clear “non,” provided that the specific application of a national court’s evidentiary rules do not result in the burden of proof in Article 4 being disregarded or undermined.  Whether Article 4 precludes national evidentiary rules that are based on presumptions (such as a set of pre-determined causation-related facts) according to which, in circumstances where medical research has not established a causal link between the administering of the vaccine and the disease, a causal link can automatically be established?
    4. The second question raised by the Cour de Cassation was the following:
    5. could lead a national court to consider that the injured party has discharged its burden of proof under Article 4 (see para [41]).

In response to this question, the CJEU raised strong concerns. In particular, the CJEU held that establishing a set of pre-determined facts to automatically establish a causal link would make such presumptions irrefutable. This would therefore deprive the defendant from adducing evidence or putting forward arguments (such as scientific arguments) to rebut that presumption, which would not be a fair or effective result. Even if the defendant could rebut the presumption, the burden of proof would effectively be on the defendant rather than the injured party. This would therefore undermine the burden of proof of the injured party set out in Article 4 of the Product Liability Directive.

Based on the above analysis, the answer to the question was a strong “oui.”

There is no general Daubert requirement of verifiable scientific basis for causation in the EU. The CJEU’s judgment is a disturbing development as it lowers even further the standard of proof required from the injured party. However, as highlighted above, the national courts must ensure that the evidence provided is sufficiently serious, specific and consistent (however that might be interpreted) to warrant the conclusion that, notwithstanding the producer’s evidence, a defect in the product appears to be the most plausible explanation for the occurrence of the damage. Although the standard is lower, it is still a threshold. If the CJEU were to find causation without medical proof, the evidence brought by the injured party would have to be very compelling.

Now the pessimists – or perhaps “realists” – out there who remember the pre-NVICP vaccine litigation cases may think that this could make it too easy for plaintiffs to establish causation where there is no corroborating medical evidence and, as happened in the United States, result in a downturn in the availability of vaccines in Europe. Experts in the field are clearly concerned.

However, the full implications of this case are still unclear, and will perhaps remain unclear for some time. The case clearly reduces the burden of proof on the plaintiff, thus raising the spectre of adverse market consequences, but it remains to be seen how this will be adopted in practice by the national courts of the Member States.

In terms of the case at hand, the CJEU did not appear to contradict the most recent decision of the Cour d’Appel in Paris, which found that the plaintiff had not proved causation. It could (we wish) be a Pyrrhic victory for the plaintiff who, ironically, will likely be found by the relevant French court to have not proved causation.

We should also remember that this CJEU case concerns the application of national evidentiary rules. In this case, the French law of evidence set out in its Civil Code. As each Member State will have its own national evidentiary rules, the impact of the CJEU decision will vary depending on the relevant Member State’s own evidentiary rules.

Causation or no causation, that remains the question

As Voltaire so intelligently put:

« Le hasard est un mot vide; rien ne peut exister sans une cause »

(“Chance is a word void of sense; nothing can exist without a cause”)

Earlier this week, we posted on the Ninth Circuit’s conversion of the Daubert’s gate (that the trial court should keep) into more of a swinging saloon door.  A week before the Ninth Circuit ruled that a trial court had erred in excluding unreliable causation testimony (and granting summary judgment as a result), the Third Circuit had affirmed a trial court’s exclusion of unreliable causation testimony (and grant of summary judgment as a result).  Even though we are discussing In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., __ F.3d __, 2017 WL 2385279 (3d Cir. 2017), second, it really is a bigger deal because it reaffirmed the end of an entire MDL.

We followed the district court’s Daubert rulings on the epidemiology and mechanism experts offered for all the plaintiffs.  We watched in amazement as the plaintiffs got to try again and still could not offer reliable expert testimony on general causation.   With our typical restraint, we applauded the court’s subsequent decision that no plaintiff could make out a case for general causation between maternal use of the drug and the cardiac birth defects claimed without the excluded experts and that was fatal to their claims.  We found that the plaintiffs, maybe because of the sympathy associated with their claimed injuries, got plenty of leeway before the court determined that there was simply no there (i.e., good science) there.  (Along the way, we saw that Pennsylvania and West Virginia state courts came to similar conclusions.)

The appeal to the Third Circuit focused on whether the biostatistician offered as a back-up expert on epidemiology was properly excluded, with plaintiffs conceding that they should have lost if he was.  Plaintiffs’ central contention was that the district court created a standard that requires general causation opinions to be “supported by replicated observational studies reporting a statistically significant association between the drug and the adverse effect.”  We think that standard, similar to Havner and Daubert II, is a fine standard, but the district court did not create or apply such a standard in knocking out the biostatistician.  Likewise, the Third Circuit declined to “state a bright-line rule” that “statistical significance is necessary to prove causality.”  (We think it is, because the Bradford Hill Criteria, which the biostatistician purported to apply, starts with an association demonstrated through epidemiologic studies.  We will try to resist arguing for the tighter standard given the result.)  The district court considered the lack of multiple statistically significant studies supporting an association to be contrary to what teratologists generally require and thus relevant to whether an opinion without such support was unreliable.  A flexible approach to evaluating the reliability of a general causation opinion was fine with the Third Circuit and its reading of the Bradford Hill Criteria.  (There is flexibility, but only when there is an association from epidemiologic studies as a predicate.  OK, we will have to try harder.)

The Third Circuit “accept[ed] that the Bradford Hill and weight of the evidence analyses are generally reliable.  We also assume that the ‘techniques’ used to implement the analysis (here, meta-analysis, trend analysis, and reanalysis) are themselves reliable.”  That assumption is dicta—which is a good thing—because the court concluded that the biostatistician did not reliably apply the methodology or techniques that he claimed to be applying.  First, he gave lip service to analyzing “multiple positive, insignificant results,” but he really just eyeballed trends.  Second, his trend analysis was based on cherry picking and inconsistent application of basic statistics principles.  Third, his meta-analysis was also result-driven, as he could not justify why he included some studies and excluded others.  Fourth, his reanalysis was done for no reason but to conclude that a published study reporting no association should have found one.  Altogether, “the fact that Dr. Jewell applied these techniques inconsistently, without explanation, to different subsets of the body of evidence raises real issues of reliability.  Conclusions drawn from such unreliable application are themselves questionable.”

The court probably could have stopped there.  It went on to detail how the biostatistician’s purported application of Bradford Hill was riddled with errors that he could not explain.  This was more than enough to conclude that the district court had not abused its discretion in excluding the expert.

Along the way, however, it noted that it may be possible to have a reliable reanalysis that draws a different conclusion than the original published study and that an expert can make unsupported assumptions in connection with doing an “informational” reanalysis.  It offered that “[t]hese inquiries are more appropriately left to the jury.”  We disagree and think the broader context has to be considered.  A plaintiff’s expert offered on the epidemiologic evidence who cannot offer a reliable opinion that there is an association between the exposure and the type of injury the plaintiff claims, let alone that there is a causal relationship, should not be talking to the jury about anything.  A plaintiff’s expert offered on the epidemiologic evidence who can offer a reliable opinion that there is a causal relationship between the exposure and the type of injury the plaintiff claims can be allowed to discuss the various analyses she did to form that opinion.  And the defense can cross-examine her on whether some of her analysis was result-driven for-litigation drivel or based on unsupported assumptions.  A jury can hear that sort of back and forth and decide what weight to give to the expert’s testimony on general causation.  However, no trial court should abrogate its gatekeeping role and let juries hear about reanalysis of published studies unless plaintiffs have reliable evidence of general causation in the first place.  I guess we prefer the opinions of the district court, which took its gatekeeping seriously, even if it let plaintiffs take a few shots at entry.

With the Phillies stinking the joint out – off to their worst start since World War II – and both of Boranian’s local teams in last place, too (not as deeply buried as the Phillies), use of baseball imagery might seem a bit painful right now.  Only our DC-based blogger has had anything worth cheering about lately, and with what’s going on there recently….  Baseball must be a welcome distraction.

But a one-two-three inning was what came to mind in looking at the new decisions that turned up last week. We were struck by three relatively easy wins for defendants.  Individually, they would not warrant separate post, but under a “totality of the evidence” standard, when added together, we found them worth discussing

The first is N.K. v. Abbott Laboratories, 2017 WL 2241507 (E.D.N.Y. May 22, 2017), a Depakote/birth defects case.  There are a number of these cases around, and we have already commented on several.  But we have to say, if the other side’s experts are as poor as they were in N.K, this litigation deservedly isn’t going anywhere.  N.K. went away on summary judgment after all of the plaintiff’s “experts” – and the term deserves to be in quotes – were excluded from testifying.  The first purported expert was the minor-plaintiff’s treating pediatrician, who was totally out of her depth:

[The witness] has never conducted research on Depakote or valproic acid. Nor has she researched the effects of in utero exposure to valproic acid (“valproate exposure”).  Prior to [minor plaintiff’s] first visit, her knowledge of Depakote was limited to refilling prescriptions for epileptic patients.  Since that initial visit, she has conducted little to no additional research on Depakote, valproic acid, or valproate exposure.

2017 WL 2241507, at *2 (record citations omitted).  Unsurprisingly, the court found this witness “not qualified to testify that Depakote caused [minor-plaintiff’s] injuries.”  Id. at *3.  She possessed no applicable medical experience nor had she bothered even to review the relevant literature.  Id. (she “did not perform any research or make any additional investigation that might qualify her as an expert on valproate exposure”).  Instead, “[h]er attempts to understand the cause of [minor-plaintiff’s] injuries were limited to a single review of a single medical book, the day of his first visit.”  Id.  This is hardly the kind of expert we would expect to see in litigation where a strong causation case is present.

The second expert in N.K. “ha[d] a more substantial background” – it could hardly have been less – but was not even a medical doctor.  Id. at *4.  Again, we would not expect to see this kind of “expert” in a strong case.  Lack of a medical degree is a problem.  “[C]ourts have consistently drawn a distinction between the qualifications of medical and non-medical doctors, noting that non-medical doctors who are qualified to diagnose a medical condition may be unable to reliably determine its cause.”  Id.  This witness was a “teratologist and toxicologist,” but had no relevant diagnostic expertise.  “[B]y his own testimony he has never evaluated children, has never been called upon to diagnose dysmorphic features or autism in a child, and is not a clinician.”  Id.

Nor did these unqualified “experts” use proper methodology.  They both purported to engage in the last refuge of a Daubert scoundrel – differential diagnosis.  The pediatrician “viewed [minor plaintiff’s] condition as either genetic or the result of prenatal valproate exposure.”  Id. at *5.  Which one didn’t she investigate?

She reached this conclusion before eliminating any genetic causes. . . .  Not only did [she] fail to eliminate alternative causes before reaching her initial conclusion, she lacked the knowledge to independently rule out genetic causes.

Id.  Genetics were a serious alternative  “[A]t least four other treating physicians have recommended further genetic testing to determine the cause of [minor plaintiff’s] injuries.”  Id.  The court could hardly be faulted for wondering what these plaintiffs were hiding in not having this testing done.

The other expert – the one that wasn’t even a doctor – was, if anything worse.  He “did not conduct his own independent investigation,” rather “[h]is opinion is based entirely on reviewing existing reports provided to him by Plaintiffs.”  Id. at *7.  Having to spoon-feed an expert is another indicator of a weak case.  Beyond that, his “attempt to rule out potential alternative causes of [minor plaintiff’s] condition is plagued by the same problems as” the pediatrician’s.  Indeed, “[h]e relied on [her] flawed report in ruling out genetic causes.”  Id.

Finally, plaintiffs failed to slip the pediatrician’s opinions in the back door, as “factual” testimony by a treater.  A treater’s testimony was equally subject to Daubert:

Even if such an opinion could be read into her records, classifying [her] as a fact expert does not relieve this Court of its duty to ensure she utilized reliable methods in reaching her opinion.  Courts in this district have found that when a treating physician seeks to render an opinion on causation, that opinion is subject to the same standards of scientific reliability that govern the expert opinions of physicians hired solely for the purposes of litigation.

Id. at *8 (citations and quotation marks omitted).  To us, this is the most significant legal ruling in N.K.

Summary judgment granted.  One away on a dribbler to the mound.

Next up, Rincon v. Covidien, 2017 WL 2242969 (S.D.N.Y. May 22, 2017). Rincon failed on a motion to dismiss, because of TwIqbal.  Rincon involved hernia mesh, and an alleged injury suffered more than six years after implantation.  Id. at *1.  Plaintiff’s complaint had a rather fundamental – and fatal – flaw.  It failed to allege that a defect caused the alleged injuries:

[Plaintiff] fails to allege any facts that plausibly establish such causation. . . .  Taken together, these facts − even liberally construed (not that there is a basis for liberal construction here) − fall far short of demonstrating that [defendant’s] mesh was a “but for” cause of [her] later injuries. . . .  Nothing in the Amended Complaint even endeavors to explain why the mesh is a more likely, let alone proximate, cause of [plaintiff’s] alleged harms.

Id.  One would have thought that, with an obvious serious timing issue, the plaintiff would have tried harder in Rincon to allege the sort of critical facts supportive of causation.  The absence of these facts is another marker of a weak case.

But not only did the plaintiff in Rincon fail to allege causation; she also failed to allege defect:

Under New York law, Rincon must prove the existence of a defect. . . .  But [plaintiff] fails to allege a defect except in the most conclusory terms:  that [defendant] manufactured the PCO mesh, that the mesh was used during her hernia surgery in 2006, that she needed subsequent medical procedures in 2012 and 2013, and thus [defendant] must not have “properly manufactured, tested, inspected, packaged, labeled, distributed, marketed, examined, sold, supplied, prepared and/or provided [ ] the proper warnings” regarding the mesh.

Id. at *2.  To make matters worse, plaintiff tried to make up her pleading defects in her brief opposing dismissal.  The court was not impressed.  Those assertions “serve only to illustrate the deficiencies in her Amended Complaint − namely, that it does not identify any actual defect in the coating and says nothing about how the coating, even if defective, caused [her] specific injuries.”  Id.

On top of that, plaintiff only “suggest[ed],” but did not actually seek, leave to amend.  Id.  Plaintiff’s notably poor pleading resulted in dismissal with prejudice.   “[E]ven if [she] were to add her new ‘facts’ . . ., her claims would all still fail for the reasons discussed above.”

Called third strike.  Two down, and add one to our TwIqbal cheat sheet.

The final out was made by Merancio v. Smith & Nephew, Inc., 2017 WL 2257124 (E.D. Cal. May 23, 2017), where summary judgment was granted after the plaintiffs failed to retain the allegedly defective implant.  The complaint itself was a mess, which certainly did plaintiffs no favors.  “[N]either factual details concerning plaintiffs’ claimed injuries nor specific legal theories of liability have been alleged in any detail.”  Id. at *1.  Having lost the device that supposedly failed plaintiffs “presented no substantive evidence concerning the merits of their claims.”  Id.  Instead, they pursued another all too common “last refuge of a scoundrel” tactics – attempting to litigate the defendant’s supposed discovery lapses.

That didn’t work this time.  Whatever deficiencies (if any at all) in the defendant’s initial disclosures were irrelevant by the time summary judgment rolled around.  Even if the identity of the affiant who supported the summary judgment motion was disclosed too late, it was disclosed “well prior to the close of discovery,” and the witness “was ultimately deposed by plaintiffs.”  Id. at *4.  Like too much pine tar on a bat, the violation, if it existed at all, was harmless.  Or, to mix sports metaphors, “no harm, no foul.”  “Plaintiffs have made no showing that they were prejudiced by the timing of defendant’s disclosures.  Indeed, plaintiffs have made no allegations of any harm − not even general, vague, and conclusory ones − flowing from defendant’s allegedly belated disclosures.”  Id.

So plaintiffs tried again, arguing that the court should ignore the defendant’s affidavit, which was factually undisputed, because the affiant “failed to include a list of cases in which he has appeared as an expert.”  Id. at *5.  The court was having none of plaintiffs’ trivial pursuit.  If plaintiffs thought this deficiency was so important, they should have done something about it earlier, rather than pursue a nitpicking litigation strategy:

[P]laintiffs’ counsel never asked defense counsel or the expert for this list and never filed a motion to compel with the court seeking the information or the imposition of sanctions. . . .  Again, plaintiffs do not even generally suggest how they have been harmed as a result of these minor deficiencies in [defendant’s] expert report.  Indeed, when asked at the hearing on the pending motion, plaintiffs’ counsel suggested he purposefully did not pursue any further efforts to obtain the list of cases in which [the affiant] had appeared as an expert because, in counsel’s view, it made defendant’s expert “attackable.”

Id. (emphasis added).

With plaintiffs’ discovery smokescreen blown away, summary judgment was inevitable.  “It [was] undisputed on summary judgment that, at the time the parts used in [plaintiff’s] knee replacement left the control of defendant, they had been inspected, passed quality control inspections, and were in compliance with all applicable FDA regulations.”  Id. at *7.  Defect at sale is a “necessary element” of strict liability.  Id.  Further, California simply does not recognize strict liability design defect claims involving prescription medical products.  Id.  Negligence failed because of a “complete failure of proof” that the device failed when it shouldn’t have.  Id. at *8.  Finally, plaintiffs’ warranty claim was dismissed (in addition to the above grounds) on an interesting legal ruling − that the personal injury damages were not available for alleged breach of contract:

Here, plaintiff seeks general damages for pain, suffering, and inconvenience, and special damages for medical expenses, future medical expenses, loss of earnings, [plaintiff] seeks here are generally not cognizable in claims sounding in contract in California.

Id. (citations omitted).  Finally, with no evidence “that the defendant negligently injured” her spouse, that wife-plaintiff’s consortium claim bit the dust. Id. at *9.

Side retired on a (very) foul popup.

Weak claims all in N.K., Rincon, and Merancio. Daubert, TwIqbal, and simple failure to prove the claim defeated these actions, and did so fairly expeditiously.   Which is as it should be.  Weak claims have no business being brought, and where plaintiffs are unable to hide weak claims in MDLs, these cases demonstrate that (at least in the federal courts), the civil justice system still works.

This post is from the non-Reed Smith side of the blog.

The plaintiff thought she had a strong summary judgment opposition. She included the deposition testimony of her prescribing doctor, who suggested that Boston Scientific’s warnings for the pelvic mesh device were inadequate. And she included her own affidavit, in which she said that she wouldn’t have agreed to let her doctor implant that device in her if she’d known that it could cause the negative life changing conditions that she allegedly later suffered. Plaintiff thought her opposition was enough to save her failure to warn claim. It wasn’t. The MDL court granted partial summary judgment. It turned out that Plaintiff’s opposition papers contained a big gap—no evidence of proximate causation. Plaintiff offered no evidence that her doctor read Boston Scientific’s Directions for Use (“DFU”). And, if her prescribing doctor didn’t read the DFU, changing it to include the allegedly proper warning wouldn’t have changed anything, particularly her doctor’s decision to prescribe.

That wasn’t the end for plaintiff, though. She had other claims that survived and that she could take to trial. That trial, however, would happen before a different court.  After its summary judgment decision and completing other pretrial matters, the MDL court transferred the case back to the original transferor court for trial.

Plaintiff saw this as an opportunity. She moved the new court to reconsider the MDL court’s summary judgment decision. Her basis was that, in fact, her prescribing doctor had read the DFU. The plaintiff had simply failed to present that portion of his deposition testimony to the MDL court. On that basis, she asked the new trial court to change the MDL court’s decision and deny summary judgment against the failure to warn claim.

No luck. She lost her reconsideration motion.

So, with no failure to warn claim, Plaintiff went to trial.

She lost there too.

Undaunted and still fighting to revive her failure to warn claim, plaintiff appealed to the Fourth Circuit. She challenged both the MDL court’s original summary judgment decision and the trial court’s denial of her motion to reconsider that decision.

And she lost again.

All of this is described in the Fourth Circuit’s recent opinion. Carlton v. Boston Scientific Corp., 2017 WL 1854278 (4th Cir. May 9, 2017). The Fourth Circuit saw plaintiff’s problems as both substantive and procedural. Substantively, a failure to warn claim cannot survive without evidence that the doctor would have read the warning. Id. at *3. Procedurally, it’s not the court’s job to find the evidence that supports proximate causation. It’s the parties’ job to present that evidence to the court: “The responsibility to comb through the record in search of facts relevant to summary judgment falls on the parties—not the court. We therefore affirm the MDL court’s partial summary judgment award.” Id.

Her procedural failings were particularly problematic on her challenge to the trial’s court’s denial of reconsideration. This wasn’t new evidence on which she was relying. It was evidence that had indisputably been available at the time the MDL court decided the summary judgment motion:

At oral argument, Appellant’s counsel asserted that in light of this late revelation, the MDL court’s summary judgment award constituted clear error causing manifest injustice. Not so. We have consistently affirmed denials of motions to reconsider summary judgment rulings where the motion is merely a vessel for the very evidence that was initially lacking in opposition to summary judgment. Significantly, the entirety of Dr. Kennelly’s deposition testimony was available well before summary judgment briefing, and the additional portions of testimony Appellant provided to the district court for “reconsideration” thus did not amount to the type of evidence constituting grounds for a valid motion for reconsideration. We therefore affirm the district court’s denial of Appellant’s motion for reconsideration.

Id. at *4.

While not for lack of fighting on plaintiff’s part, we suspect that this one is now finally over.