The district judge in the In re Zimmer Nexgen Knee Implant Products Liability Litigation MDL issued a summary judgment order in October 2016 that we called “the best Wisconsin law decision we have ever seen.”  What was the reason for our unusually unbridled enthusiasm?  The district judge debunked the idea that the learned intermediary rule does not apply in Wisconsin.  We have often heard that refrain, but we have always been skeptical.  The truth is that Wisconsin’s appellate courts have not addressed the issue, and the In re Zimmer Nexgen judge predicted that Wisconsin’s Supreme Court would adopt the learned intermediary rule if given the opportunity.

The Seventh Circuit has affirmed that order, so its opinion now inherits the mantle of “Best Wisconsin Law Decision We’ve Ever Seen.” That title is cemented not only by the adoption of the learned intermediary doctrine, but also the rejection of a heeding presumption, which is also very helpful.  We note that the three judges who issued this opinion have spent a combined 83 years on the Court of Appeals and that the author of the opinion spent five years on the Wisconsin Supreme Court.  Maybe the latter fact was considered when assigning the opinion; maybe it was not.  Regardless, it is a clear-minded and well-reasoned opinion that we commend to anyone who has grappled with warnings claims in Wisconsin.

Here is what happened. The plaintiff sued a knee implant manufacturer alleging design, manufacturing, and failure-to-warn claims after his prosthetic knee replacement loosened, which is a known complication of all joint replacement procedures. In re Zimmer Nexgen Knee Implant Prods. Liab. Litig., No. 16-3957, — F.3d –, 2018 WL 1193431, at *1 (7th Cir. Mar. 8, 2018).  Following summary judgment, the plaintiff raised only the warnings claims on appeal and argued that the manufacturer failed adequately to warn both the plaintiff and his surgeon.

Of course, an alleged failure to warn the plaintiff raises the application of the learned intermediary rule, which “holds that the manufacturer of a prescription drug or medical device fulfills its duty to warn of the product’s risk by informing the prescribing physician.” Id. at *2.  Because neither the Wisconsin Supreme Court nor the state’s intermediate appellate courts have addressed the rule, the Seventh Circuit undertook an Erie analysis. Id. at *3.

Although we would like to believe that the Seventh Circuit reviewed our frequently updated 50-state survey on the learned intermediary rule, it is more likely the court did its own research or relied on that provided by the manufacturer.  What it found was one Wisconsin trial court opinion applying the doctrine and noting its widespread acceptance. Id. at *3 (citing Staub v. Berg, No. 00-cv-0117, 2003 WL 26468454 (Wis. Cir. Ct. Jan. 6, 2003)).  The Court also found three federal district court opinions invoking the learned intermediary doctrine under Wisconsin law, and one case called Maynard v. Abbott Labs observing that “Wisconsin does not apply the learned intermediary doctrine.” Id. On this last point, the Seventh Circuit was particularly blunt:  “That statement is incorrect—the Wisconsin Supreme Court has never weighed in on the topic [and] Maynard itself is bereft of any analysis on the point.” Id.

The Seventh Circuit also relied on the learned intermediary doctrine’s “broad support in other jurisdictions,” including 48 states where the highest court or the intermediate appellate courts have adopted the doctrine in some form. Id. Finally, the rationale for the learned intermediary rule applies even more forcefully in cases involving surgical implants because “it is not reasonably conceivable that an individual could obtain and implant a device that requires a trained surgeon without the intervention of a physician.” Id. Amen.

The following holding and the reasoning upon which it is based are what make In re Zimmer Nexgen the Best Wisconsin Law Opinion We’ve Ever Seen:

In short, there is good reason to think that given the opportunity, the Wisconsin Supreme Court would join the vast majority of state supreme courts and adopt the learned-intermediary doctrine for use in defective-warning cases like this one involving a surgical implant. We predict the state high court would do so.  Accordingly, to the extent that [the plaintiff’s] defective-warnings claim is based on [the manufacturer’s] duty to warn him, it is foreclosed by the learned-intermediary doctrine.

Id. at *4.  For good measure, the Seventh Circuit held that the plaintiff’s direct warnings claim failed also because the plaintiff did not identify any danger about which that the manufacturer should have warned him and because he had no evidence of causation.  Even if the plaintiff would have heeded a different warning, “[he] didn’t select the NexGen Flex implant.”  His surgeon did.  Id.

The Seventh Circuit likewise rejected the plaintiffs’ argument that the manufacturer failed adequately to warn the surgeon.  The plaintiff cited the defense expert’s testimony that he would have used more cement to place the implant and argued that the manufacturer failed to warn about the amount of cement needed. Id. at *4.  But that was not sufficient because “no evidence supports [the plaintiff’s] contention that it was [the manufacturer’s] responsibility to instruct surgeons about the amount of cement they should use.” Id. at *5.  This surgeon relied exclusively on his education and training, not on any materials from the manufacturer, and the plaintiff offered no expert opinion that the warnings were inadequate in any event. Id.

Finally, the Seventh Circuit rejected the warnings claims on causation. The surgeon did not read the instructions for use and could not been affected by a different warning. Id. at **5-6.  The plaintiff urged the Seventh Circuit to apply a “heeding presumption,” i.e., a presumption in the absence of proof that the surgeon would have read and heeded a proper warning. Id. at *5.  But Wisconsin law squarely places the burden of proving causation on the plaintiff.  As the Seventh Circuit held,

Here again, the state appellate courts have not addressed this doctrine [the heeding presumption]. We seriously doubt that they would adopt it in this context.  [¶]  To the contrary, as we’ve already noted, the state court of appeals has recently held that “[a] plaintiff who has established both a duty and a failure to warn must also establish causation by showing that, if properly warned, he or she would have altered behavior and avoided injury.”

Id. (citing Kurer v. Parke, Davis & Co., 679 N.W.2d 867, 876 (Wis. Ct. App. 2004)).  In other words, since Wisconsin law already places the burden of proving causation on the plaintiff, the Seventh Circuit would not alter that law by creating a presumption.

The plaintiff’s last request was to certify questions to the Wisconsin Supreme Court, which the Seventh Circuit rejected because “[n]o genuine uncertainty exists here.” We could not agree more and would not be surprised to see this opinion on our Ten Best list at year end.

(Note that this post comes from the Cozen O’Connor side of the blog.)

Good morning. Do you have your coffee? If so, start sipping it. You will need it. Because this morning we’re going to discuss leads for implantable cardiac defibrillators (“ICD”), Riata Leads to be precise. Now, while this may not be the most thrilling subject, you have to admit that Riata Leads is a solid name. It sounds like something important, like rock-solid leads for selling real estate, the type of game-changing leads that Shelly “the Machine” Levene would plot to steal from his boss’s office. Like the Glengarry leads. But these are not the Glengarry leads. They truly are ICD leads, ones that detect a patient’s abnormal heartbeat and deliver an electric shock to restore a normal heartbeat. So take another sip of your coffee.

Plaintiff Richard Connelly alleges that in 2003 his doctors surgically connected Riata Leads to his heart but that, in 2010, the leads improperly shocked him 16 to 20 times while he slept, causing damage to his heart and requiring surgery to replace them. Connelly v. St. Jude Med., Inc., 2018 WL 732734, at *2 (N.D. Cal. Feb. 6, 2018). Plaintiff hired a lawyer and sued, claiming that St. Jude, the manufacturer, failed to file adverse event reports about the Riata Leads and that, if it had, plaintiff’s doctor would not have implanted them or, in the least, would have removed them after he did implant them. Id. at *1-2.

As you can probably tell already, this is another parallel violation claim. So take another sip. Plaintiffs file a lot of these claims. We write about them often. And they often fail, for many reasons. This one failed because plaintiff didn’t adequately allege causation. In particular, his complaint didn’t connect the defendant’s alleged failure to file adverse event reports about the Riata Leads to his doctor’s decision to implant them or leave them in.

In this respect, the allegations had a number of problems. They had a timing problem. The allegations did not plausibly suggest that the defendants failed to file adverse reports about the Riata Leads before they were implanted in plaintiff, which happened in 2003. Id. at 3. The allegations had regulatory problems. While the FDA issued a 483 Report covering the years 2002 to 2009 noting that the defendant failed to file adverse event reports on Riata Leads, plaintiff did not identify a single failure to file a report before the Riata Leads were implanted in him in 2003. Id. The allegations had defect identification problems. The FDA inspection that resulted in the 483 Report focused on malfunctions in the Riata Leads due to perforation, but the defect alleged by plaintiff had to do with improper abrasion. Id. OK, take one last sip of coffee. We’re almost there.

Finally, plaintiff claimed that defendant’s failed to file adverse event reports about Riata Leads after they were implanted in him, resulting in his doctor not removing them. This theory failed as a matter of California law, which does not allow such claims:

[T]o the extent Connelly’s claim is premised on a theory that St. Jude had a post-distribution (i.e., post-implantation) duty to warn, this fails as a matter of law. Under California law, a defendant may be held strictly liable for a failure to warn only if “the defendant did not adequately warn of a particular risk that was known or knowable…at the time of manufacture and distribution.” Anderson v. Owens-Corning Fiberglas Corp., 810 P.2d 549, 558 (Cal. 1991).

Id. at 4.

Having already dismissed plaintiff’s complaint once before, this time the Court dismissed it with prejudice.

Ok, all done. Now “Put . . . that . . . coffee . . . down! (I’m here from downtown. . . . I’m here from Mitch and Murray.)

We have written extensively on the travesty of the Neurontin trilogy (like here and here) and noted how the plaintiffs’ efforts to fit cases based on alleged off-label promotion of the prescription SSRIs Celexa and Lexapro into the same rubric have not been as successful. Today’s case addresses what we understand to be some of the last few cases in the MDL.   In re Celexa & Lexapro Mktg. & Sales Practs. Litig., MDL No. 09-02067-NMG, 2018 U.S. Dist. LEXIS 13579 (D. Mass. Jan. 26, 2018).  This summary judgment decision addresses three cases, one by a third party payor on behalf of a purported class and two by parents of former pediatric users.  As always, we reserve the right to focus on the parts we want and to make gratuitous statements about how these cases exemplify much of what is wrong with civil RICO and consumer fraud cases over prescription drugs.

A little background on the litigation and these cases should help.  The allegations centered on the claim that the manufacturer of these drugs had caused economic injury to the plaintiffs by promoting the use of the drugs for pediatric patients when they were only approved for adult use.  To dispose of the plaintiffs’ cases, the court did not have to resolve whether the manufacturer engaged in such promotion, let alone whether any promotion was untruthful—which we think it would need to be to impose liability consistent with the First Amendment.  Celexa was approved to treat depression in adults in 1998 and an application to treat depression in adolescents was filed in 2002.  FDA denied that application based on a lack of efficacy in one of the two clinical studies.  Lexapro was approved to treat depression in adults in 2002 and an application to treat depression in adolescents was filed in 2008 and approved a year later.  The Celexa label always stated that “safety and effectiveness in pediatric patients have not been established” and, starting in 2005, described the results of certain pediatric trials.  The Lexapro label had similar language until the pediatric indication was added.  The first individual plaintiff sued over the prescription, purchase, and intermittent use of Celexa by a thirteen year old depressed patient in 2002-2003.  The second individual plaintiff sued over the prescription, purchase, and use of Celexa and later Lexapro by an eight to fifteen year old autistic patient from 2003 to 2010.  The TPP plaintiff sued over prescriptions paid for a relatively small number of Celexa prescriptions for pediatric beneficiaries from 1999 to 2004 and for a somewhat larger number of Lexapro prescriptions for pediatric beneficiaries between 2012 and 2015, but also claimed to represent a nationwide class of payors.  The plaintiffs asserted a mix of federal civil RICO and state consumer fraud claims and, skipping some procedural history, the court entertained summary judgment motions.

The consideration of the RICO requirements of injury and causation resolved all issues. For those of you who know RICO or have just followed along with some of our posts, RICO requires an injury to “business or property” as a matter of standing.  Relying on the Neurontin cases, these plaintiffs claimed that they had been injured because they paid for drugs that were not effective for the indications for which they were prescribed.  They claimed, however, that any payment for an off-label prescription was an injury because they contended that FDA had somehow been defrauded in connection with the applications for pediatric indications.  2018 U.S. Dist. LEXIS 13579, *19.  If you are following along, then you might wonder how this theory could apply to Celexa prescriptions or the earlier prescriptions of either drug.  First things first, though, as the Celexa court had to unpack the Neurontin rulings to see if they supported plaintiffs’ relaxed standard.  They did not, so plaintiffs had to prove lack of efficacy.  The TPP and second plaintiff could not:  “[T]he FDA in this case approved the drug for use in adolescents.  There is no conclusive or even strongly suggestive evidence of inefficacy in this case and plaintiff have presented no evidence as to the inefficacy for [the second plaintiff] or for any of [the TPP’s] plan members.” Id. at *22.  As one might expect with prescriptions over the eight years, the second individual plaintiff’s prescribing physician testified that the drugs had been effective with the patient’s autism.  The TPP’s evidence resembled what we have seen in other cases—no proof from physicians for the plan beneficiaries and the plan still pays for pediatric prescriptions for both drugs, contrary to the allegations in the case.

Plaintiffs’ attempted end run was that they had experts who would say FDA was somehow defrauded about efficacy for pediatric use—presumably just for Lexapro, as FDA rejected the only application for a pediatric indication for Celexa, and not for autism, as that was not an indication for either drug.  As the court noted, and we will let the Neurontin characterizations lie, plaintiffs’ “fraud theory is a tenuous attempt to shoehorn the facts of this case into the facts of Neurontin, where there were no positive, or even equivocal, clinical trials for the indications at issue.” Id. at *25.  Here, FDA “determined that two clinical studies were positive” and “FDA is the exclusive judge of safety and efficacy and a court should not question that judgment unless new information not considered by the FDA develops.” Id. (internal quotes and citation omitted).  Keep in mind that RICO is federal, so there is no preemption.  Not too shabby.  And summary judgment for the manufacturer on two of the plaintiffs.

On the remaining plaintiff, the first individual, the manufacturer challenged causation.  In part because we think the analysis was somewhat confused, we will skip to what mattered and probably applies to other plaintiffs with similar claims.  The prescribing physician’s testimony did not support reliance on a sales representative’s discussion of Celexa at all. Id. at *30.  While he did acknowledge a possibility of some unrecalled exposure to off-label promotion, this is not enough to avoid summary judgment on an issue for which the plaintiff bears the burden of proof.  “A mere possibility that the doctor could have, at some point, encountered off-label promotion, although he has no memory of it, does not rise to the level of a disputed material fact.” Id. at **30-31.  That sounds like what courts are supposed to say when evaluating a summary judgment motion on proximate cause for failure to warn with a prescription medical product.  The court here called this “but-for causation,” but we will not quibble. Summary judgment was awarded to the manufacturer on the last plaintiff’s RICO claim and the analysis on RICO determined the result of the various consumer fraud claims.  Like we said up front, this was all without reaching whether the manufacturer did anything wrong with its promotion.


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

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

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

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

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

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

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

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

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

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

Today we are talking about a case that is not exactly in the heartland of what we generally examine.  It is not a product liability or mass tort case.  But it is reasonably close.  It is kind of an off label promotion/False Claims Act case.  Okay, let’s admit what it really is: a wrongful discharge/employment case.   The plaintiff alleged that she was constructively discharged because she blew the whistle on what she perceived to be unlawful off label promotion.  The notion of causation is front and center.  The causation issue is always near and dear to our defense hearts.

And yet.  And yet.  Not so long ago we watched a mock jury reach agreement that whether or not the product caused the plaintiff’s injury, the mock jurors were hell-bent on awarding damages.  The jury decided that there were things about the company’s conduct that could be improved, and their verdict would set such improvements in motion.   Swell.  The mock jurors were essentially mocking the jury instructions.  Causation-schmausation.  We shudder at the realization that real, not mock, jurors also do this.  Every. Damned. Day.

Today’s case is also literally near to us, because it was authored by the Third Circuit, which is just down the street from several of us DDL blogsters.  It is also apparently a decision of first impression on the appellate level — that a “but for” (and not a lesser “motivating factor”) causation standard is necessary for FCA retaliatory discharge claims.  So sit back and take in this DDL-adjacent blogpost, wherein we lay out a significant ruling on a significant issue by a significant court.

The case is DiFiore v. CSL Behring, LLC, 2018 U.S. App. LEXIS 92 (3d Cir. Jan. 3, 2018), and is primarily focused on the federal False Claims Act (FCA) anti-retaliation provision protecting employee-whistleblowers who engage in activity protected by the FCA.The district court granted summary judgment in favor of the employer on the wrongful discharge claim because the plaintiff had failed to show constructive discharge as a matter of law. Then the FCA retaliation claim proceeded to trial. The judge instructed the jury that the FCA retaliation provision required that protected activity be the “but-for” cause of adverse actions against the employee. In the jury instruction, the judge listed some, but not all, of the alleged adverse actions.  The jury found in favor of the employer.  On appeal, the employee raised three arguments:  (1) the court improperly granted summary judgment on the state law wrongful discharge claim; (2) the but-for causation standard for retaliation was too exacting; and (3) the court erred by not listing all the alleged adverse actions in its jury instruction.  That middle issue is the reason you are reading about the DiFiore case on the DDL.  Otherwise, you’d have to run to an Employment Discrimination Law (EDL) blogpost to find out about it.

The Third Circuit rejected these arguments and affirmed the decisions below.  We will get to the Third Circuit’s analysis momentarily, but let’s first supply a bit more background.  The plaintiff in DiFiore had risen to Director of Marketing. That’s a pretty high position for a whistle-blower.  The plaintiff took issue with what she saw as off-label marketing strategies, such as reference to off label sales in forecasts.  The plaintiff expressed her concerns to her supervisors, and she claimed in her lawsuit that the company initiated a third-party compliance audit in part because of her complaints.  So far so good.  But the plaintiff contended that, as a consequence of her protected conduct, she suffered several adverse employment actions, including warning letters about her interactions with other employees and failure to pay off her company credit card charges, an uncharacteristically poor performance review, deteriorating relationships with supervisors, diminution of duties, removal from a committee, and a Performance Improvement Plan (PIP) that she interpreted to be a death knell.  The PIP required improvement the designated areas within 45 days or she could be subject to discipline up to and including termination.  According to the plaintiff, most employees hit with a PIP were eventually terminated.  After receiving the PIP, the plaintiff reached out to a supervisor and an HR employee and requested a meeting to discuss an amicable separation.  The meeting was canceled for unspecified reasons.  Then the plaintiff resigned.  Then the plaintiff sued.

1.  Wrongful discharge

The plaintiff in DiFiore was not actually fired, so she needed to allege constructive discharge.  Under Pennsylvania law, constructive discharge occurs when working conditions “are so intolerable that a reasonable employee is forced to resign.”  The court concluded that while the plaintiff might have been subjected to difficult or unpleasant working conditions, those conditions fell well short of being unbearable. You might (certainly a plaintiff lawyer would) suggest that the difference between unpleasant and unbearable could be a jury question.  But the court emphasized that the plaintiff “did not sufficiently explore alternative solutions or means of improving her situation. She made no attempt to comply with the PIP.”  She chose to resign rather than reschedule the canceled meeting.  None of that was disputed. Based on those facts, the court held that no reasonable jury could find constructive discharge.

2. But-for Causation for Retaliation

This is the issue that most interests us.  We more than occasionally noodle over False Claims Act cases, off label promotion, and a little thing called causation.  Under the FCA’s anti-retaliation provision, an employee is entitled to relief if she was “discharged, demoted, suspended, threatened, harassed, or in any other manner discriminated against in the terms and conditions of employment because of lawful acts” conducted in furtherance of an FCA action. 31 U.S.C. § 3730(h)(1).  The district court (we are in an Inn of Court with this Judge, and he is lightning smart and relentlessly fair, by the way) ruled that the plaintiff was required to show that her protected activity was the “but-for” cause of an adverse action.  Thus, that standard found a home in the jury instructions.  The plaintiff in DiFiore argued that a lower standard applies and she should have been required to prove only that her protected activity was a “motivating factor” in the adverse actions taken by the employer.  That “motivating factor” resides as dicta in an earlier Third Circuit decision, but in the meantime SCOTUS came out with a pair of decisions interpreting identical “because of” language in similar statutes (ADEA and Title VII) to require that illegal motive (age-ism or retaliation) be the “but-for” cause of the employer’s adverse action. Even if the earlier Third Circuit “motivating factor” language was not mere dicta, the intervening SCOTUS precedents controlled (there was no need for an en banc call), so the district court got it right.  The jury was properly instructed, and the defense verdict was affirmed.  Lesson for DDL practitioners: even if you do not do much employment work, remember that statutory “because of” language translates into a but-for standard.

3. Listing of adverse employer actions

The plaintiff contended that the district court’s inclusion of only four of the alleged adverse employer actions in the jury instructions—the two warning letters, the mid-year performance review, and the PIP—may have confused the jurors and led them to believe that they were not permitted to consider evidence of other incidents beyond those four events. But the Third Circuit took in the totality of the circumstances below, including that the district court correctly instructed the jury that its determination should take into account the totality of the circumstances. The district court instructed the jury that the four events occurred “among other things.” The district court’s list was, on its face, illustrative, not exhaustive.  It is hard to say that the district court got it wrong, and it is impossible to say that the omission of certain examples was prejudicial.  The district court’s failure to follow the plaintiff’s list exactly could not be a basis for reversal.

We’re now into the New Year but aren’t completely done with the old one.  The name of the first month of the year, January, is conventionally attributed to Janus, the Roman god of beginnings, gates, transitions, and doorways.  (We say “conventionally” because some sources report that January is actually named after its tutelary deity, Juno.) Janus, like some of our opponents, is two-faced.  Janus looks both forward and backward.  Bexis last month took a couple of long looks backward at 2017’s best and worst cases.  We’re still scrolling through the various Ten Best of 2017 culture lists for ideas, confirmations, and occasional outrages.  An in-house lawyer we endlessly respect pointed us to The New Yorker’s  list of top tv programs.  It’s hard to quarrel with Emily Nussbaum’s choice of The Leftovers, a fever-dream about love and loss (and a lion sex boat) as the best drama.  She was also right to praise American Vandal, the show that made us laugh out loud the most.  (The Good Place came in second on that score.)  Nussbaum also gave honorable mention to Halt and Catch Fire, an AMC show that really did seem to catch fire after its first, flawed season.  HACF stopped acting like a Mad Men, difficult-guy retread, shifted focus to the female protagonists,  and successfully steered us through the digital revolution – from PC clones to gaming to community chat boards to security to the web to PayPal to Yahoo to something even sexier than a lion sex boat: the Next Idea.  In seasons 2-4, HACF managed to show us (rather than merely tell us) how “computers aren’t the thing; they are the thing that gets us to the thing.”  That ‘thing’ is human connection. But you already knew that, right? There is an episode after the death of a major character that is the best depiction of grief and its clumsy toggling between the transcendent and the quotidian that we’ve seen.  The dead leave a lot behind.  Some of it goes to Goodwill.  Some of it survives in silly stories.  Some of it gets caught in our throats and some of it squeezes our tear ducts hard.  If you are looking for something to binge, consider The Leftovers, American Vandal, and Halt and Catch Fire (and maybe Patriot, The Americans, and Mindhunter).  You might also want to set aside an hour to take in episode 8 of Twin Peaks: The Return because you need to relive your college experience of attending a midnight showing of something arresting and supremely weird. 

Today’s post takes us back to 2017 for a case that is neither particularly arresting nor even a little bit weird.  Rather, the result seems inevitable.  In Siddoway v. GlaxoSmithKline LLC (In re Avandia Mktg., Sales Practices & Prods. Liab. Litig.), 2017 U.S. Dist. LEXIS 203885 (E.D. Pa. December 12, 2007), the plaintiff alleged that he sustained a heart attack from taking Avandia, and that the label did not warn him adequately.  The facts here, both regarding the plaintiff’s use and the regulatory backdrop, lead ineluctably to the defendant’s victory on summary judgment.   The plaintiff was initially prescribed Avandia from 2001 through 2002. In 2003, the plaintiff suffered two heart attacks, and ultimately underwent a successful heart transplant operation. He blamed Avandia for those heart attacks.  Following the heart transplant, a different doctor prescribed Avandia to the plaintiff. The plaintiff continued to take Avandia from December 2003 through June 2007, and did not experience any other adverse cardiovascular condition.

Let’s go backward for a moment.  When Avandia was initially approved by the FDA in 1999 to treat Type II diabetes, the drug’s label contained no warning of an increased risk of heart attack. But in 2007 – four years after the plaintiff’s heart transplant — the FDA issued a safety alert for Avandia, notifying consumers that “data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.”  The FDA directed that a boxed cardio warning be added to the Avandia label.  So there’s your lawsuit, right?

Not quite.  Now let’s go forward.  After the label change and after the plaintiff filed his lawsuit, the manufacturer and the FDA conducted extensive research on Avandia’s safety. In 2013, the FDA ultimately concluded that there was no increased risk of heart attack associated with Avandia use compared to alternative diabetes medications. Thus, in 2014, the FDA approved an updated Avandia label that removed the boxed warning for a potential increased risk of heart attack.  Good science led to good news for patients, but not such good news for this particular patient’s lawsuit.  All of the plaintiff’s nine causes of actions essentially boiled down to failure to warn theories, and the facts on the ground had removed all support for that theory.  Even putting aside the question of whether the original label was inadequate because it lacked a warning that had now been repudiated by the FDA, the plaintiff’s case failed for inability to show that the alleged failure to warn was the proximate cause of the plaintiff’s injuries.  To the extent that specific claims bumped against the learned intermediary doctrine (Utah law governed, so the learned intermediary doctrine was alive and well), the plaintiff faced a huge problem when it came to posing the usual question to the prescriber:  knowing what you know today, would you still have prescribed this medicine to the plaintiff?  From his deposition testimony, it is clear that the prescriber’s “understanding of Avandia’s risk profile today is the same as it was when he prescribed Avandia to [the plaintiff]—that Avandia is not associated with an increased cardiovascular risk compared to other diabetes drugs.  He also testified that, if the current package insert were in place when he was prescribing Avandia to [the plaintiff], he still would have prescribed it.”  That is pretty inescapable logic.  John Adams once said that “facts are stubborn things.”  So is science.  So are label changes. 

But the plaintiff did try to escape the facts, the science, and the label changes.  He pointed to the prescriber’s testimony that he “quit using” Avandia for patients after 2007.  But that same prescriber’s testimony made clear that even when the 2007 data on which the plaintiff based his claims is considered along with the other Avandia risk data available today, he would still prescribe Avandia to the plaintiff, just as he had in 2001 and 2002, when there was no heart attack risk warning in the Avandia label. It is as if the plaintiff tried to preserve his case by seizing upon one favorable moment in time and excluding any other, subsequent facts that might prove inconvenient.  Don’t look forward, and don’t look backward.  Just look at the evidence in that nanosecond that might support a claim.  But no decent doctor would do that.  Nor would any sensible court.  Hence, the Siddoway court held that the plaintiff had failed to establish a genuine issue of material fact as to whether the prayed-for warning would have deterred the doctor from prescribing Avandia to the plaintiff before he suffered the 2003 heart attacks.  The court looked at all the evidence, forward and backward, and saw its way clearly towards complete dismissal of the case.   


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.