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A couple of weeks ago, we reported on the terrific Daubert decision in the Mirena IIH MDL in the Southern District of New York, In re Mirena IUS Levonorgestrel-Related Prods. Liab. Litig., 2018 WL 5276431 (S.D.N.Y. Oct. 24, 2018), in which the court granted the defendants’ motions to dismiss all seven of the plaintiffs’ remaining general causation experts.  In that post, we explained that all seven opined that the defendants’ intrauterine contraceptive device caused idiopathic intracranial hypertension (“IIH”), a rare and potentially serious condition market by increased cerebrospinal pressure in the skull.  Only one study had ever found a causal link between Mirena and IIH.  That study was by Dr. Mahyar Etminan, who was on the plaintiffs’ payroll at the time he published the study, a fact he failed to disclose.  After a prominent scientist in the field attacked the methodology of the Etminan study because it failed to control for age and gender, Dr. Etminan repudiated much of the study’s analysis and withdrew as an expert.

Of the seven remaining experts, four drew their general causation conclusions largely by drawing on existing sources, including varying combinations of case reports regarding Mirena, case reports regarding other contraceptive products containing LNG, another product’s warning label, the repudiated portions of the Etminan study, and another study (the “Valenzuela study”) that reported a statistically significant association between LNG-containing devices and IIH but which, the authors emphasized, found only a correlation, not a causal link.  The other three experts were “mechanism” experts, each of whom postulated a supposed mechanism by which the defendant’s product could cause IIH.   In our last post, we reported on the court’s decisions regarding two of the experts in the first group but we promised to tell you more.  Today, we focus on one more expert in that group as well as highlights of the court’s decisions about the “mechanism” experts.

The former, the plaintiffs’ ophthalmology expert, was the only one of the plaintiffs’ experts who had written about the relationship between levonorgestrel (“LNG”), the synthetic hormone in  the defendants’ contraceptive device, and IIH, and was the only one of the plaintiffs’ experts who had written an expert report on the supposed causal  link before the MDL was formed.      In a 2015 book about drug-induced ocular side effects, the expert had stated that he believed there was a “possible,” but not a “probable,” association between LNG and IIH.  In the book, he explained that he assessed causation as possible “when there is a temporal relationship, but the association could also be explained by concurrent disease or other drugs or chemicals,” and dechallenge data (information about what happens when the treatment is withdrawn) is “lacking or unclear.”  Mirena, 2018 WL 5276431 at *47 (citation omitted).   In contrast, causation is “probable” or “likely” when “there is a temporal relationship unlikely to be attributed to a concurrent disease or drugs” and there is positive dechallenge data.  Id.   The book’s conclusion that there was a “possible” causal association between LNG and IIH was based largely on case reports involving the defendants’ product and other LNG-containing products and upon two publications discussing several of those case reports.  The book did not consider the Etminan and Valenzuela studies, which had not yet been published.

Unlike the other experts in the first group, the ophthalmologist did not claim to have performed a Bradford Hill analysis.  Instead, in support of the expert’s causation conclusion, his report cited case reports, discussion of another LNG-containing product, case reports, and citations to both the Etminan and Valenzuela studies.  In addition, the report included a vague discussion of broad propositions from which he suggested that there was a biological mechanism for LNG to cause IIH.  In his deposition, however, he repudiated this “mechanism” opinion, testifying that the mechanism was “unknown” and that he was not being offered as a “mechanism” expert.

Analyzing the expert’s opinion, the court stated, “[The] proposed testimony amounts to a blend of disparate items that [the expert] contents together show that Mirena causes IIH. . . . [The expert] does not purport to use the flexible Bradford Hill methodology to guide his analysis.”  Instead, he used a “non-replicable mode of analysis” consisting of “listing factors that he argues support his conclusion.”  Id. at *50.   The court held that the expert’s proposed testimony “fails to meet any of the Daubert reliability factors.”   The expert’s causation conclusion “has not been tested; it has not been subject to peer review; it has no known error rate and there are no standards controlling its operation; and it has not been generally accepted by the scientific community.”  Moreover, the expert’s “handling of virtually every one of the individual items on which he relies” was “methodologically suspect.”  Id.   This included overlooking the fatal flaws in the Etminan study, the expert’s failure “to engage with consequential evidence contrary to his outcome.”   Id.  at *51-52.  Finally, though the expert “[made] his mechanism opinion an important component of his expert report,” he “repeatedly distanced himself” from that opinion at his deposition, “repudiate[ing] any mechanism opinion as beyond his expertise.”  The court held, “”The removal of that pillar alone is fatal to [the expert’s] weight of the evidence analysis;” moreover, the “mechanism” opinion would have been inadmissible in any event because the expert was not qualified to offer it.  Id. at *52.   And so, holding that the expert’s opinions failed to satisfy Daubert’s reliability standards, the court excluded the opinions in their entirety.

The plaintiffs’ “mechanism” experts fared no better.  One, an OB/GYN and the founder of a clinical and epidemiological research organization devoted to reproductive health issues, “embrace[d] the ‘androgen theory’ by which Mirena purportedly causes IIH—specifically that androgens cause IIH and that because LNG, while a progestin, has androgenic effects, LNG in turn may cause  IIH.”  Id.  at *53.  The court held, “As a threshold consideration, [the] theory that Mirena  causes IIH through androgenic side effects does not satisfy any of the four Daubert reliability factors.”  Id. at *58.   But beyond the flaws in the opinion’s premises, the court “discern[ed] a broader overarching lapse of methodology” affecting the mechanism opinion: the expert’s report did not address the threshold issue of “what IIH is and how this condition comes about.”   Id.  In addition, the court criticized (in extensive and thorough detail that is beyond the capacity of these pages) the expert’s “scant attention to the pharmacokinetic process that must underlie the causal sequence that he postulates” and his “speculative leaps in support of his two central premises:  that androgens can cause IIH, and that LNG, a progestin with androgen receptor affinity, can cause IIH.”  Id.   The court concluded,

“In the end, while [the expert’s] credentials are sterling, the methodology underlying his opinion in this case is not.  He relies on supposition and attempts to link disconnected studies by others.   And he uses some of his source material for more than it can fairly support.  The result is a hypothesis that may or may not bear up when and if it is ultimately tested, not a reliable expert opinion admissible under the governing standards.  The Court therefore must exclude his testimony.”  Id. at *62.

The court similarly dispatched the plaintiffs’ other two mechanism experts because their methodologies were unsound and their theories failed to satisfy Daubert’s reliability standards.  Both discussions are lengthy and we cannot do justice to them here, but we again recommend that you read the whole opinion when you have time to appreciate its rigor and its unflinching confrontation and dissection of the technicalities underlying all of the experts’ opinions.  Doing justice to Daubert analysis of opinions like these is a monumental task.   All too frequently, and perhaps understandably, courts decline even to try, counting on juries (or, more likely, settlements) to do their work for them.   The Mirena court displayed rare dedication to the principle that the system can work only if courts properly discharge their duties as “gatekeepers.”  We applaud this decision, urge you to read it and cite it, and we hope that more courts will accept similar challenges.  We will keep you posted.

Kudos to the multifirm defense counsel team that brought home the decision on which we report today, a victory that may well end up on our “best” list for 2018.

In April 2017, we posted about Dr. Mahyar Etminan, then an expert in the Mirena MDL pending in the Southern District of New York.  Plaintiffs in the MDL claimed that the defendant’s product, an intrauterine contraceptive device containing the synthetic hormone levonorgestrel (“LNG”) caused them to develop idiopathic intracranial hypertension (“IIH”), also known as pseudotumor cerebri, a rare and potentially serious condition marked by increased cerebrospinal fluid pressure in the skull.   In 2015, Etminan had published a study designed to assess the risk of IIH.  Although the study did not definitively conclude that defendant’s product caused IIH, Etminan concluded that one of the two analyses, a “disproportionality analysis” of adverse events in the FDA’s FAERS database, identified an increased risk of IIH associated with LNG and that this result was statistically significant.  Etminan concluded that the results of the second analysis, a retrospective cohort study, did not find an increased risk but that this result was not statistically significant.   No other study has ever established a causal link between LNG and IIH.

Subsequently, a prominent scientist in the field attacked the methodology of Etminan’s disproportionality analysis because the study failed to control for age and gender, resulting in erroneous and misleading conclusions.  At the same time, it was revealed that Dr. Etminan was on the plaintiffs’ payroll at the time that he published his study, a conflict of interest he had not disclosed.  Ultimately, after defendants served Dr. Etminan with a notice of deposition in one of the cases in the MDL, Dr. Etminan repudiated much of his study’s analysis and withdrew as an expert.   When we reported this, we told you to “stay tuned,” commenting that plaintiffs’ other experts, all of whom relied on Etminan’s results, had not withdrawn.

The other shoe dropped a couple of weeks ago.  In In re Mirena IUS Levonorgestrel-Related Prods. Liab. Litig., 2018 WL 5276431 (S.D.N.Y. Oct. 24, 2018), the court considered the defendants’ Daubert motions to exclude the plaintiffs’ seven remaining general causation experts.  And it granted them all.   The opinion is very long – seventy-two pages on Westlaw – and we commend it to your weekend reading, as we can’t begin to do justice to the court’s detailed analysis of each expert’s methodology.  But we wanted to bring this terrific decision to your attention and to focus its most important takeaways.

The court began its analysis by emphasizing, “In the face of [the] historical record, with no medical organization or regulator or peer-reviewed scientific literature having found that Mirena or any contraceptive product using LNG is a cause of IIH, an expert witness who would so opine . . . necessarily would break new ground in this litigation.”  Mirena, 2018 WL 5276431 at *20.  All seven of the plaintiffs’ general causation experts “so opined.”  Four of these experts “arrived at this result largely by drawing upon existing sources.”  These included varying combinations of case reports regarding Mirena, case reports regarding other contraceptive products containing LNG, another product’s warning label, the repudiated portions of the Etminan study, and another study (the “Valenzuela study”) that reported a statistically significant association between LNG-containing devices and IIH but which, the authors emphasized, found only a correlation, not a causal link.  The remaining three experts were “mechanism” experts, each of whom postulated a supposed mechanism by which the defendant’s product could cause IIH.   In this post, we will focus on two of the experts in the first group, which included an epidemiologist, a toxicologist, an OB/GYN, and an ophthalmologist, but we urge you to read the court’s dissection of the second group as well.

The plaintiffs’ epidemiology expert was a professor of biostatistics with experience in conducting and analyzing large clinical trials.   He claimed that the nine Bradford-Hill criteria supported his causation conclusion.  As many of you know, the criteria are “metrics that epidemiologists use to distinguish a causal connection from a mere association.” Id. at *23 (citation omitted).  They are:  statistical association (also known as “strength of association), temporality, biological plausibility, coherence, dose-response effect, consistency, analogy, experimental evidence, and specificity.

The court first held that the epidemiologist’s opinion did not satisfy any of Daubert’s four reliability factors, because the expert “has not tested his theory.  He has not subjected it to peer review or had it published.   He has not identified an error rate for his application of the nine Bradford Hill factors. . . . And [his theory] has not been generally accepted by the scientific community.”  Id. at *27 (internal punctuation and citation omitted).  With respect to this last, the court again emphasized, “Outside of this litigation, there is a complete absence of scholarship opining that Mirena, or, for that matter, any LNG-based contraceptive, is a cause of IIH.”   Id.  As such, the court undertook to “take a hard look” at the expert’s methodology, scrutiny that was “particularly warranted” because:

 [I]t is imperative that experts who apply multi-criteria methodologies such as Bradford Hill . . . rigorously explain how they have weighted the criteria.  Otherwise, such methodologies are virtually standardless and their applications to a particular problem can prove unacceptably manipulable.  Rather than advancing the search for truth, these flexible methodologies may serve as vehicles to support a desired conclusion.

Id.  (citations omitted).    Citing four examples of how the expert’s assessment of individual Bradford Hill factors “depart[ed] repeatedly from reliable methodology,” the court held, “Measured against these standards, [the epidemiologist’s] report falls short.  Id. at *28-29.

First, the expert used the “analogy” factor, basing his causation conclusion in part on an analogy to another contraceptive product.  But, the court explained, this analogy was based on an “unestablished hypothesis” about the other contraceptive product, for which a causal relationship with IIH had never been substantiated.  Id. at *29.  With regard to the “specificity” factor, the court explained that the factor “inquires into the number of causes of a disease,” id., with the difficulty of demonstrating a causal association escalating along with the number of possible alternative causes.   “In finding the specificity factor satisfied,” the expert “devote[d] two sentences to his discussion.”  Id.   He relied on a conclusory statement to the effect that alternative causes could be ruled out.   And he relied on the Valenzuela study, which had actually disclaimed a finding of causation.   The court explained that the “consistency” factor required “similar findings generated by several epidemiological studies involving various investigators” reaching the same conclusion.  Id. at *30.    Again, the epidemiologist claimed that the Valenzuela study satisfied this criterion because it considered two separate populations.  But, as the court stated, both studies were conducted by the same investigators, and neither found a causal relationship.  Finally, as to the biological plausibility factor, the epidemiologist postulated a biological mechanism by which he said LNG could cause IIH.  The court stated, “ . . . [B]y any measure, [the expert] is unqualified to give an expert opinion as to a biological mechanism of causation of IIH.”   Id. at *30.   This lack of qualifications compromised the expert’s assessment of the biological plausibility factor as well as of related factors.   The court concluded,

Each of [the expert’s] departures from settled and rigorous methodology favors the same outcome.  Each enables him to find that the Bradford Hill factor at issue support concluding that Mirena is a cause of IIH. . . . [His] unidirectional misapplication of a series of Bradford Hill factors is concerning – it is a red flag.  Rather than suggesting a scholar’s considered neutral engagement with the general causation question at hand, it suggests motivated, result-driven, reasoning. . . . Methodology aimed at achieving one result is unreliable.

Id. (internal punctuation and citation omitted.    The court went on to further eviscerate the epidemiologist’s methodology, criticizing his reliance on the Valenzuela study, his nearly-exclusive use of case reports to support three of nine Bradford Hill factors, his failure to consider evidence that undercut his opinions, and his cherry-picking of case reports that supported his desired conclusion.   The court concluded that the expert’s testimony was “compromised by a range of serious methodological flaws,” and failed to satisfy Daubert’s reliability standard.

The court voiced similar criticisms of the methodology of the plaintiffs’ toxicology expert.  Like the epidemiologist, the toxicologist failed to meet any of the four Daubert reliability standards  In applying the Bradford Hill factors, she failed to identify support for her conclusions, distorted or disregarded evidence that undercut her opinions, failed to articulate a plausible biological mechanism to support her causation conclusion, and drew an inapposite analogy to another contraceptive product.   And her opinions were plagued by additional methodological flaws.   She relied on the portion of the Etminan study that was discredited and that Etminan himself repudiated.  And she cited the Valenzuela study as her sole support for finding several Bradford Hill criteria satisfied without acknowledging the study’s methodological limitations and failure to find causation.   The court concluded, “[The toxicologist’s] proposed testimony is beset by methodological deficiencies.  It falls far short of satisfying Daubert’s standard of reliability.  Her testimony, too, must be excluded.”  Id. at *40.

And so it went with the court’s discussion of the rest of the plaintiffs’ experts.   The opinion does the best job we’ve ever seen of demonstrating how an expert can attempt to create the illusion of reliability by paying lip service to the Bradford Hill criteria and how those criteria can be manipulated to mask wholly result-driven ipse dixit opinions plagued by fatal methodological flaws.   In this case, a committed and rigorous judge stemmed the tide.  But we all know that this is not always the case.

We love this decision.  There is a lot more to say about it, and we look forward to telling you more in an upcoming post.

J.P.M.L. Denies Request for New Gadolinium MDL

“Eventually, all things merge into one, and a river runs through it. The river was cut by the world’s great flood and runs over rocks from the basement of time. On some of the rocks are timeless raindrops. Under the rocks are the words, and some of the words are theirs. I am haunted by waters.”  Norman Maclean, “A River Runs Through It.”

Last weekend, we stood on the banks of the Flathead River, just outside of Glacier National Park.   We retreat to Montana, every now and then, when we need to restore our soul.  This we have in common with Maclean, for this is where he wrote his novel about fly-fishing and life, to the extent that there is a distinction between the two.  As we stood under the aptly-named “big sky,” with the river at our feet and the mountains in the distance, we felt tucked into our proper berth in the cosmos and all of the proportions felt right.

In the very short decision about which we report today, a group of plaintiff lawyers needed the J.P.M.L.’s smackdown to be relegated to their proper place in the jurisprudential universe.  In In re Linear Gadolinium-Based Contrast Agents Prods. Liab. Litig., 2018 WL 4905435 (J.P.M.L. Oct. 10, 2018), plaintiffs in seventeen gadolinium cases moved to centralize the suits in a new MDL. This would be the second MDL go-round for gadolinium.   You can read some of our posts about the first MDL here.

Gadolinium is a contrast agent.  Plaintiffs allege that it causes injury when it is retained in the body after it is used for radiological testing.  This time around, the plaintiffs argued that their suits should be centralized either in the Northern District of California or in the District of Massachusetts.   The defendants argued that the cases should not be consolidated, or, in the alternative, that the J.P.M.L. should stay its decision until general causation discovery was completed in actions pending in the District of Arizona.

The J.P.M.L. concluded that “centralization would not serve the convenience of the parties or further the just and efficient conduct of [the] litigation.”  Gadolinium, 2018 WL 4905435 at *1.  First, the Panel held that the plaintiffs had “failed to demonstrate that any common questions of fact and law [were] sufficiently complex or numerous to justify centralization.”  Id.  This was because several different product formulations, from different manufacturers, were involved, and the injuries “appear[ed] to be highly plaintiff-specific. . . .”  Id.  In addition, because most plaintiffs were represented by a single law firm or by other firms working with that firm, centralization was unnecessary.  As the Panel stated, “Given the significant overlap of plaintiffs’ counsel, alternatives to transfer exist that may minimize [the] possibilities . . . of duplicative discovery and/or inconsistent pretrial rulings.”  Id. at *2.  And then came the music to the ears of all of us who spend our professional lives watching plaintiffs abuse the MDL framework:  “. . . [C]entralization under Section 1407 should be the last solution after review of all other options.”  Id. (citations omitted).  Bexis tells us that this seems to be the first time the Panel has issued this admonition in the context of prescription medical product liability litigation.   We hope it’s not the last, and we’ll keep you posted.

In the meantime, thumb through “A River Runs Through It.”  It’s magic.  We promise.

Next week, under pressure from the Drug and Device Law Lifelong Best Friend, we are participating in a “murder mystery dinner theatre” in the “conservatory” of a local cemetery.   (We didn’t know cemeteries had “conservatories.”) It is a Halloween-themed event, with costumes encouraged, and we may or may not wear our eerily-lifelike Standard Poodle mask/hood. In any event, the premise of the event is that actors are scattered among the paying audience “guests.” At some point during the cocktail hour, one of the actors will “die.” During the ensuing dinner hour, clues are revealed and everyone tries to solve the “murder” in time for dessert. We think this sounds like fun, and we like the idea of not knowing what to expect and not being able to predict the result.

But sometimes a predictable result (to the extent that preemption jurisprudence is ever predictable) is just fine. In In re Bard IVC Filters Prods Liab. Litig. (Hyde v. C. R. Bard, Inc.), 2018 WL 4356638 (D. Ariz. Sept. 12, 2018), the plaintiff was implanted with the defendant’s inferior vena cava (“IVC”) filter. Three years later, the plaintiff learned that the filter had perforated the IVC wall and had fractured. The filter was removed shortly thereafter. The plaintiff filed suit, asserting the usual panoply of product liability claims. After the court granted summary judgment for the defendant on several claims, the plaintiff’s claims for strict liability design defect and negligent design remained pending, along with a claim for negligence per se.

Under Wisconsin law, which governed the plaintiff’s substantive claims, a claim for negligence per se arises from violation of a statute, where the plaintiff can show that “(1) the harm inflicted was the type the statute was designed to prevent; (2) the person injured was within the class of persons sought to be protected; and (3) there is some expression of legislative intent that the statute become a basis for imposition of civil liability.” Hyde, 2018 WL 4356638 at *2. In her negligence per se claim, the plaintiff asserted that the defendants violated provisions of the Federal Food, Drug, and Cosmetic Act. As the court commented, “Far from containing an expression that FDA regulations are intended to form the basis of civil liability, . . . [t]he FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.” Id. (citing Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4 (2001)) (internal punctuation and additional citations omitted).   “Thus,” the court continued, a private litigant cannot bring a state-law claim [that] is in substance . . . a claim for violating the FDCA – that is, when the state claim would not exist if the FDCA did not exist,” because, under Buckman, such claims are impliedly preempted by the FDCA.  Id. (citations omitted). All correct, even if it conflates Buckman preemption with the plaintiff’s simple failure to state a negligence per se claim under the requirements of Wisconsin state law.

The court held that, as in Buckman, the plaintiff’s negligence per se claim was more accurately characterized as a “negligence claim based solely on violations of FDA regulations,” id., and was therefore impliedly preempted. As the court emphasized, “. . .where the plaintiff was not suing under state law for conduct that happen[ed] to violate the FDCA, but instead [was] suing solely because the conduct violate[d] the FDCA,” the claim was preempted by federal law. Id. (emphasis in original, internal punctuation and citation omitted). The court contrasted such claims to traditional tort claims like plaintiff’s negligent design claim, which arose from a duty owed under state law and which was not subject to Buckman preemption.

We like this correct, methodical, predictable decision.   We’ll let you know how the mystery thing goes.

Recently, the Enviably Youthful Drug and Device Law Mother has been pushing us to plan a mother/daughter vacation.   Her longtime companion no longer enjoys travel, and few of her friends share her sense of adventure. So we set about finding a suitable trip for next spring. Threshold categorical decisions proved troublesome. Our normal instinct, given the pace of our everyday life, is to sit still on vacation. We are fond of cruises, and we don’t care to where because we don’t get off of the boat.   The EYDDM prefers an eight-cities-in-seven-days pace. If we have to move, we prefer to rent a car and explore – we are not fond of printed itineraries. And we lean toward countries with national languages other than English. So, in the spirit of compromise, we booked eight days on a bus in Ireland over Memorial Day. Yeah, we know. But you should have seen the EYDDM’s smile. Sometimes, the answer is simple.

As it was in today’s case.   In Romer v. Corin Group, PLC, et al., 2018 WL 4281470 (M.D. Fla. Sept. 7, 2018), the plaintiff alleged that he was injured by when the defendant’s artificial hip implant released metallic contaminants into his body, causing pain and malfunction of the device and ultimately requiring another surgery. He sued in state court on the usual product liability theories, and the defendants removed the case on diversity grounds. After removal, the defendants moved to dismiss the negligence, negligence per se, and strict liability claims.

Listing seven alleged manufacturing defects in the hip implant, the negligence per se claim alleged that the defendants failed to comply with the manufacturing standards the FDA approved as “conditions of FDA’s approval [as well as] the general regulations applicable to Class III medical devices.” Romer, 2018 WL 4281470 at *3. A second negligence per se count alleged that the defendants’ simulator testing of the device was inadequate and violated federal regulations related to the compliance with Approved Design Standards. Id.   The defendants argued that both counts failed as a matter of law because Florida does not recognize a claim for negligence per se based on alleged violations of the federal FDCA or its implementing regulations. The court agreed, holding that, “[u]nder Florida law, the violation of a federal regulation does not create civil liability based upon a theory of negligence per se in the absence of a legislative intent to create a private cause of action.”   Id. at *4 (citations omitted). Because the FDCA and its implanting regulations do not “expressly create civil liability for non-compliance, strongly suggesting a legislative intent not to create a private cause of action,” id., the plaintiffs could not base negligence per se claims on the violations they alleged.

The defendants argued that the design defect claims sounding in both strict liability and negligence were preempted under Riegel because the hip implant device was a Class III medical device subject to pre-market approval (“PMA”) by the FDA. While the plaintiffs argued that the design defect claims escaped preemption because the claims were “based on defendants’ alleged failure to comply with federal laws after the FDA already approved the design of the device,” id. at *5, they made no allegation that the defendants had altered the design approved by the FDA during the PMA process.   The court concluded, “To the extent plaintiffs are asserting parallel claims, . . . . a valid parallel claim cannot challenge the rigorous PMA process itself or the requirements imposed by the FDA pursuant to that process. However, plaintiffs’ design defect claim does just that,” id at *6, and it was therefore expressly preempted.

Similarly, the defendants argued that the plaintiff’s negligence claims, based on the defendants’ alleged failure to warn of defects in the hip implant device or to report adverse events to the FDA, were expressly preempted because they sought “to second-guess the FDA’s determination that the warning language [was] adequate and [to] force [the defendant] to meet an additional standard beyond what the FDA requires.” Id. The defendants also argued that the reporting violations claims were impliedly preempted.

The court held that the warnings claims “imposed requirements that [were] different from, or in addition to, the federal requirements under the MDA,” and were thus expressly preempted. To the extent that the plaintiffs claimed that the defendants failed to comply with FDA reporting requirements, the claim was “simply an attempt to recast a claim for violation of the FDCA as a state law negligence claim.” Id. at *7. As such, it was “premised upon an FDA-reporting requirement that [was] not paralleled by a Florida law duty,” and was impliedly preempted under Buckman, which permits such claims to survive only to the extent that they “do not seek to privately enforce a duty owed to the FDA.” Id.

And so the court dismissed the plaintiffs’ design defect, failure to warn, and “failure to report” claims, leaving manufacturing defect claims pending. The dismissal was without prejudice, and the plaintiffs were given fourteen days to file an amended complaint. We’ll keep you posted

We have always had a soft spot for zebras.   They are the equine world’s version of some of our favorite acquaintances — the ones who always dress a little outlandishly and always stand out from the crowd. (Fun facts:   1. Although most zebras have black stripes on a white background, a white-on-black specimen shows up every now and again.   2. All zebras have dark-pigmented skin under their coats, and the stripes are only hair-deep. Compare Dalmatians, whose spots are visible on their skin from the birth, though the spotted fur comes later.)   Zebra fondness aside, we often find ourselves, in our ongoing occupation of the mass tort space, arguing that plaintiffs hearing hoof-beats should have thought “horses,” not “zebras.” Less obtusely, we mean that judges should apply the discovery rule correctly and should hold that suits are time-barred when plaintiffs with adequate information fail to make obvious causal connections within the correct limitations period.

That is why we were so happy to read today’s case. We rarely report on statute-of-limitations decisions, but Adams v. Zimmer, 2018 U.S. Dist. LEXIS 136707 (E.D. Pa. Aug. 14, 2018), is a worthy exception.   In Adams, the plaintiff underwent surgery to replace her right hip joint, and was implanted with the defendant’s prosthetic hip, in January 2011. Eight months after surgery, in September 2012, she began experiencing pain in the region of the artificial hip. When the pain didn’t abate, the plaintiff’s doctor performed blood tests to test her metal ion levels because there had been reports of adverse local tissue reaction to the metals used in the artificial hip. There was no definitive diagnosis at that time, but the plaintiff’s doctor testified that, by February 2013, he informed the plaintiff that the prosthetic hip might be causing her symptoms.

The plaintiff dislocated her right hip in November 2014.   She testified in deposition that she knew that the prosthetic hip had dislocated and that this was “abnormal.” On January 7, 2015, her doctor noted in his records that he recommended “further investigation of the right hip,” and that the plaintiff might require surgery to replace the femoral head. 2018 U.S. Dist. LEXIS 136707 at *9. In deposition, the doctor testified repeatedly that he had informed the plaintiff of his recommendation and of the possible need for revision of the artificial hip. Testing performed on January 12, 2015 confirmed a tissue reaction to the artificial hip, and, by January 30, 2015, the plaintiff had decided to proceed with hip revision surgery. In her deposition, she testified that she understood that the surgery would involve replacing the defendant’s device with a new prosthesis. She underwent surgery on February 12, 2015 and filed her complaint on February 10, 2017. The defendant moved for summary judgment, arguing that Pennsylvania’s two-year statute of limitations barred the plaintiff’s claims.

The plaintiff argued that she “did not make the factual connection” between her injury and the defendant’s device until the date of surgery.  Id. at *20. If this were true, then she would have beaten the statute by two days. But the judge wasn’t buying it. Explaining that “as soon as, through the exercise of reasonable diligence, the injured party should be able to link her injury to the conduct of another, the clock begins to run,” id. at *23-24, the court held that the plaintiff “knew or should have known that the [defendant’s device] was a factual cause of her injury by the time she decided to proceed with hip revision surgery on January 30, 2015.” Id. at *26. In other words, “once [the plaintiff] knew for certain that [her doctor] needed to remove the [device], she had received enough facts to make the connection between her injury” and the device, and “no reasonable juror could conclude otherwise.” Id. at *27. Nor was the court swayed by the plaintiff’s argument that, even if she knew that the device was causing her symptoms, she did not know it was “defective” until it was removed. The court emphasized, “This misstates the legal standard,” which required only that the plaintiff connect her injuries to the device to start the clock running on her claims. Id. at 31. Finally, while the court acknowledged that the plaintiff hadn’t missed the running of the statute by much, and that granting summary judgment would deny the plaintiff recourse for serious injuries, it held that it could not “arbitrarily enforce the statute of limitations,” however sympathetic the plaintiff, and that it was “constrained to grant the motion for summary judgment.” Id. at *33-34.

We have been on the receiving end of all of the arguments the plaintiff made in Adams. And we have fought – not always successfully – for decisions that apply the law rigorously and aren’t swayed by sympathy. We are pleased that the Adams court did just that.

This weekend, we are traveling to Nashville, where, decades ago, we lived for a couple of years during a period of wanderlust. Nashville was to be a brief stop-off on a cross-country driving odyssey.  But we never got any farther down the road, leaving Nashville only to reverse course and return to college (to our parents’ great relief).  All these years later, a huge part of our heart still lives at the intersection of Interstates 40 and 65, and we journey back as often as we can to visit friends we’ve treasured for as long as we can remember.  The town has changed, to be sure.  The tiny radio station on the hill, where we sat with a dear and now-departed friend during his late-night country music show, no longer broadcasts.  There is a pro football team now.  Buildings and highways and traffic have multiplied exponentially.  And the old Ryman Auditorium, the “mother church of country music” and original home of the Grand Old Opry, has been reborn as a concert venue.  (From the balcony of the current Opry House, looking down on the stage, patrons can see a large circle of wood that doesn’t match the rest of the floor.  This was taken from the Ryman when the new Opry House was built, to harness some of the sacred energy of that hallowed old place.)

But with all that has changed, going back still feels like going home, and the city still feels sweet and familiar, but with a twist. As does today’s case, a familiar-feeling statute of limitations decision except for the twist created by the very modern context of prescription drug addiction.  In Allen v. Indivior, Inc., 2018 U.S. Dist. LEXIS 134279 (N.D.N.Y. Aug. 9, 2018), the plaintiff, a college student and aspiring investment banker, became dependent on a narcotic pain-killing drug after a car accident.  In an attempt to wean him off of the painkiller, his doctor prescribed a drug used as replacement therapy to treat painkiller dependency.  He took the replacement drug daily for twenty months, until, his Complaint alleged, he became “completely addicted” to it.  He tried to stop using the drug and enrolled in an in-patient program to help him deal with his withdrawal symptoms.  After twenty-one days, he went home to his family, where, a short time later, he overdosed on heroin and died.   His parents sued the replacement drug’s manufacturer, asserting the usual product liability causes of action and alleging that, because of his addiction, “the only way” the plaintiff could treat his withdrawal “was with heroin.”  The defendant moved to dismiss, asserting improper venue/lack of personal jurisdiction and statute of limitations arguments.

First, the court held that venue was not proper in the Northern District of New York; instead, the case should have been filed in the District of Connecticut. The court cited 28 U.S.C. § 1406(a) for the proposition that it could, in its discretion, either dismiss the case or transfer it to the correct district.  While transfer is generally favored, the court quoted the great Judge Posner for the proposition that, if “a case [will be] a sure loser in [the correct court], then the court in which it is initially filed . . . should dismiss the case rather than waste the time of another court.” Allen, 2018 U.S. Dist. LEXIS 134279 at *8-9 (citation omitted).   And so the court proceeded to determine whether the case was a “sure loser” on statute of limitations grounds.

The court explained that, under Connecticut’s three-year statute of limitations, the plaintiff was required to serve the Complaint – not just file it – within three years after he could first attribute his injuries to the defendant’s conduct. The defendants argued that the plaintiff’s claims were time-barred because the injury at issue was the plaintiff’s addiction to the replacement drug, and that the plaintiff was aware that he was “completely addicted” to the drug – and entered the in-patient program as a result – more than three years before the complaint was even filed.

The plaintiffs argued that that the triggering event was the plaintiff’s death, not his addiction, and, adding facts they had not pled, they argued further that the cause of death was not determined until the autopsy report was issued and the toxicology results were returned, all within the three-year limitations period. The court disagreed, holding that the gravamen of the complaint was the claim that the defendants’ alleged negligence in designing and labeling the drug caused the plaintiff’s “crippling addiction,” and that the plaintiff knew he was addicted — and sought treatment for his addiction – well over three years before the Complaint was filed or served.   Even if the plaintiff’s claims did not accrue until the date of his death, the court pointed out that the defendants had not been served with the complaint three years after that date.  The court rejected the plaintiffs’ argument that an e-mail purportedly sent to one of the defendants on the three-year anniversary of the plaintiff’s death placed the defendant on “constructive notice” of the impending service of the Complaint.

And so, this “sure loser” of a case was dismissed, not transferred. We expect to see more cases arising in the context of prescription drug addiction and more  “grey areas” related to when claims accrue in that context.   We will keep you posted on this new “twist” in statute of limitations law.  And we’ll have a drink for you this weekend in Tootsie’s Orchid Lounge, across the alley from the old Ryman, fifty-eight years old and going strong.

These days, when the subject turns to victorious Philadelphia sports teams, most people think green, and “fly” and “Philly Special.” But we are not most people.  We live firmly and fondly in the past, 2008 to be exact.  So we relished every moment of our beloved Phillies’ Alumni Weekend this past weekend.  We cheered ourselves hoarse as a beloved former centerfielder, under a one-day contract, “retired as a Phillie.”  (Mahalo, “Flyin’ Hawaiian.”) And we, along with 35,000 of our closest friends, wept as the widow of our 2008 ace spoke to the crowd on the occasion of her late husband’s enshrinement on the Phillies’ “Wall of Fame.”   (R.I.P., “Doc.”)  And finally, as the members of the 2008 World Champion Phillies marched out to be honored, we allowed ourselves to be transported back to the ecstatic aftermath of our closer’s final slider in a perfect save season.  For sure, victory is sweet.

As it has been, six times now, in post-BMS personal jurisdiction decisions out of the Essure litigation.  In Hinton v. Bayer Corp., 2018 WL 3725776 (E.D. Mo. July 27, 2018), ninety-four plaintiffs from thirty different states filed a joint complaint in a Missouri state court, alleging that they were injured by the defendant’s birth control device.  The defendant removed the case to the Eastern District of Missouri on the basis of diversity jurisdiction.  Of the ninety-four plaintiffs, only thirteen were Missouri residents.  Some of the non-Missouri residents were not diverse to the defendant; however, the defendant moved to dismiss and sever the claims of the non-Missouri plaintiffs before the court ruled on subject matter jurisdiction (and remanded for lack of complete diversity).   The plaintiffs moved to stay determination of the motions to dismiss pending determination of subject matter jurisdiction, but the court declined, explaining that “addressing [the defendant’s] challenge to personal jurisdiction over the claims of the non-Missouri plaintiffs presents the more straightforward inquiry” under recent precedent, justifying a decision to deviate from the usual course of deciding subject matter jurisdiction ahead of personal jurisdiction. Hinton, 2018 WL 3725776 at *2.   As the court emphasized, “Remanding this case for lack of complete diversity only to have the case removed again later once the non-Missouri plaintiffs are dismissed would be a waste of judicial resources.  Ruling [on] personal jurisdiction first is in the interests of judicial economy and expeditiousness.” Id. (citation omitted).

And so the court proceeded to address the defendant’s motion to dismiss the claims of the non-Missouri plaintiffs for lack of personal jurisdiction. The defendant conceded that the court had specific jurisdiction over it regarding the thirteen Missouri plaintiffs, but argued that the court did not have general jurisdiction over it and did not have specific jurisdiction over it with regard to the non-Missouri plaintiffs.  The plaintiffs did not argue that the court had general jurisdiction over the defendant; instead, they argued that the court had specific jurisdiction over the defendant with regard to the claims of all of the plaintiffs because the defendant had conducted “a number of clinical trials” in Missouri and had worked on regulatory approval for the product in Missouri, and because “St. Louis was one of eight cities targeted as part of a broader marketing plan to increase sales and revenue.” Id. at *3.

The court explained that, under BMS, specific jurisdiction depends on “an affiliation between the forum and the underlying controversy, principally [an] activity or an occurrence that takes place in the forum State and is therefore subject to the State’s regulation.” Id. (citation to BMS omitted).  In this case, the plaintiffs did not see marketing in Missouri, did not purchase the product in Missouri, were not prescribed the product in Missouri, did not purchase the product in Missouri, and were not injured by the product in Missouri.  “Furthermore, none of the plaintiffs alleged that she participated in a Missouri clinical study or reviewed or relied on” such studies in deciding to use the product. Id. at *4.  As such, the court held, “Even assuming that discovery would prove exactly what Plaintiffs contend happened in Missouri with respect to . . . marketing and clinical trials, the individual plaintiffs’ claims are too attenuated from those activities to provide specific ‘case-linked’ personal jurisdiction.” Id. (citation omitted).   With no “connection between the forum and the specific claims at issue,” id. (citation to BMS omitted), the court held that it did not have jurisdiction over the claims of the eighty-one non-Missouri plaintiffs and dismissed all of those claims.

And so the defendant hit a figurative home run, expanding its already-prominent role in the elimination of litigation tourism in Missouri. We love this string of decisions, we love BMS, and we will keep you posted as its family of progeny continues to grow.

A couple of weeks ago, the Drug and Device Law Dog Walker texted us midday to report that a coyote had been spotted in our suburban neighborhood and that we should be vigilant when the Drug and Device Law Little Rescue Dogs were out in the yard. We scoffed, insisting that it must have been the neighborhood fox, known to all for years (we live right next to Valley Forge National Park).  The conversation went back and forth for a while, eventually including descriptions of larger size, different coloration, and much longer legs than the fox’s.  We remained unconvinced.  Eventually, our neighborhood e-mail chain came alive with close-up photos of what was undeniably a coyote, taken a scant hundred yards away in a neighbor’s back yard.   Because we are law nerds, it occurred to us that coyotes are just like causation:  an expert can assert a causal link, and assert it again, but, ultimately, there has to be evidence to support the assertion.

As the court agreed in today’s case, a nice (albeit unreported) affirmance of a HUMIRA summary judgment victory out of Maryland’s Court of Special Appeals. In Larson v. Abbott Labs., Inc., 2018 WL 3479236 (Md. Ct. Spec. App. July 19, 2018), the plaintiff, a highly-educated space engineer who had been diagnosed as HIV-positive years before, alleged that the defendant’s psoriasis medication caused him to become sufficiently immunocompromised that he contracted progressive multifocal leukoencephaly (PML).  PML is an often-fatal viral brain disease that left the plaintiff physically disabled and cognitively impaired, and unable to care for himself.  PML is caused by a virus that that is present in the bodies of most adults in the United States but that generally remains inactive except in severely immunocompromised people. HUMIRA’s prescribing information warned that medications of its class had the potential to affect defenses against infection, and that the safety and efficacy of the medication in immunosuppressed patients had not been evaluated.  The warnings did not specifically mention HIV patients.

The plaintiff had been diagnosed as HIV-positive five years before he took HUMIRA. During that time, he treated his plaque psoriasis with home remedies.  When it worsened, he asked his treater about treatment with HUMIRA.  She sought information from the defendant, then referred the plaintiff to a physician who concluded from the information that, because the plaintiff’s HIV was well controlled and that he was not severely immunocompromised (and because a tuberculosis skin test came back negative), he was an appropriate candidate for the medication.  What was unknown to the doctor – and apparently to the plaintiff – was that recent lab results revealed progression of his HIV disease.   (The plaintiff’s infectious disease specialist had attempted to contact him with the results, but he hadn’t responded by the time he began his HUMIRA treatment.) Within three months after beginning his treatment, he began exhibiting headaches and extreme fatigue.  His condition worsened, and he was diagnosed with PML shortly thereafter.

The plaintiff filed suit, asserting the usual product liability claims. His primary causation expert was a “highly-regarded infections disease specialist with significant experience” treating HIV-positive patients. Larson, 2018 WL 3479236 at *7.  The defendant moved to exclude the expert’s opinion.  The trial court granted the motion, and, because the plaintiff was left without expert causation testimony, the court granted summary judgment for the defendant.  The plaintiff appealed.

The plaintiff presented several questions for the appellate court’s determination, including questions related to the trial court’s holdings about the adequacy of the product’s warnings. The appellate court found that it needed to consider only one question – whether the trial court erred in barring the testimony of the plaintiff’s general and specific causation experts and granting summary judgment – because a negative answer to that question obviated the need to consider any of the others.  In the process, the court rejected the plaintiff’s argument that the it needed to address the adequacy of the warnings whether or not the plaintiff could establish medical causation.  As the court explained,

Generally, the “proximate causation element” in a failure to warn case against a pharmaceutical manufacturer is established by proof that the allegedly inadequate warning was a substantial contributing factor to the plaintiff’s injury. . . . In certain product liability cases, however, such as the case before us, the parties disagree over whether sufficient evidence exists to show that the product, itself, can cause the specific injury alleged and, therefore, whether the manufacturer had a duty to provide different or additional warning to prevent the injury. . . . . What is often termed “general causation” is present “when a substance is capable of causing a given disease. . . . General causation, therefore, relates to the element of duty — i.e., whether the risk of the type of injury the plaintiff suffered was reasonably foreseeable, and therefore, whether the manufacturer had a duty to warn the prescribing physician in the first place. . . . Evidence demonstrating [medical] causation . . . must exist independent of whether the manufacturer’s allegedly defective warning label was a proximate cause of the injury. In other words, evidence of general and specific causation was necessary in this case to establish [the defendant’s] duty to warn . . . .

Id., at *9-10. And so the court proceeded to determine whether the trial court had erred in excluding the plaintiff’s causation experts. The plaintiff’s causation theory was that “the immunosuppressant effect of HUMIRA permitted the ‘unmasking’ of [the virus that causes PML], despite the fact that” the plaintiff was not as immunosuppressed as HIV-positive patients who develop PML” even in light of his most recent lab results.  Id.  Maryland is a Frye state.  Under that standard, as the court explained, an expert’s opinion is admissible only if the basis of the opinion is “shown to be generally accepted as reliable within the expert’s particular scientific field.” Id. at *12 (internal punctuation and citations omitted). The standard applies equally to new scientific techniques and to accepted methods applied to support novel theories.

With respect to plaintiff’s main causation expert, the trial court had held that his causation conclusions “[had] not been sufficiently tested and proven to qualify as reliable forensic conclusions rather than scientific hypothesis.” Id. at *13.   The expert’s primary contention was that, “in addition to general HIV disease progression, some additional functional immune deficit must be present for PML to occur,” and that HUMIRA caused that deficit in the plaintiff. Id.   The trial court held that the expert had not considered other potential contributing factors, and that he could not provide a sufficient factual basis for his opinion that HUMIRA was “the missing link.” Id. at *14.

The appellate court stated that, “to constitute a sufficient basis for his general causation opinion, Dr. Jacobson needed to provide support for his contention that” the class of drugs was “known to be associated with an increased risk of PML” at the time the plaintiff took the drug. Id. The plaintiff contended that this support was to be found in the expert’s reference to the drug’s black-box warning about opportunistic pathogens coupled with “well-documented reports of PML occurring in patients who had received” this class of drugs.” Id. But, the court pointed out, the expert did not discuss the “well-documented reports of PML” or explain how the reports helped form the basis of his opinion.   The plaintiff also asserted that the expert relied on “peer reviewed studies, reviews of other biologicals, and FDA Adverse Event Reporting data,” but, the court found, he did not explain how the existence of case reports demonstrated a causal connection, and, the one article he cited related to a drug with a different mechanism of action than HUMIRA’s.

The court echoed the trial court’s holding that there “is sound scientific reasoning to suggest that [the drug’s immunosuppressive effect] could be a factor, but it falls short of showing with any degree of reliability that it is a factor, much less a substantial contributing cause” of the plaintiff’s PML. Id. at *15 (emphasis in original).   The court also reviewed the depositions of the plaintiff’s other experts, and held that, although they “believed that [the plaintiff’s] use of HUMIRA likely contributed to his immunological decline, none could provide a sufficient factual basis for that conclusion. . . . Indeed, [one] conceded that a scientifically reliable causal association” had not been established, id., and another stated “more unequivocally that he believed that [the plaintiff’s increased immunosuppression]” occurred “independent of HUMIRA, representing progression of his HIV disease.”  The same expert discussed an article establishing “the theoretical possibility” that the class of drugs was associated with PML, but explained that “it [didn’t] necessarily establish causation . . . .” Id.

The court commented that it agreed with the trial court that “it may well be that additional research will confirm some or all of [the expert’s] hypotheses. What is determinative in this case, however, is that those causal theories have not been established now nor were they established” when the plaintiff took the drug.  The court also acknowledged that there were ethical obstacles to conducting controlled studies on HIV-positive individuals, and that, because PML is a rare disease, “the amount of epidemiological data that could be useful is limited.”  But this didn’t excuse the experts’ theoretical causation opinions.  The court concluded, “We hold that [the plaintiff’s] experts’ opinions were not grounded on an adequate supply of data, and, therefore, the circuit court properly excluded their testimony.” Id. at *16,

We love a good expert exclusion. BTW, the coyote pictures are really cool.  E-mail us, and we will send them to you.

 

 

We spent yesterday in New York City, helping the Drug and Device Law Rock Climber (now the “Drug and Device Law Software Engineer” – yes, we are kvelling) move from one sublet to another as she continues her quest for the perfect apartment. The day was challenging, as these things tend to be. We lost count of the times we heard, “Why didn’t you tell me?” (That it was going to rain, that we would have to use the freight elevator, that we would be forced to keep moving the borrowed van because here was no legal place to leave it, that the refrigerator would bear the detritus of multiple unintentional science experiments – you get the idea. ) Each time, we responded with, “What difference would it have made?’

The plaintiff in today’s case, a tidy appellate decision in a medical malpractice case out of New Jersey Superior Court, asked the same question, and got the same answer. In Hopper v. Progressive Motion Med. Prod. Solutions, 2018 WL 2270839 (N.J. Super. Unpub. July 18, 2018), the defendant doctor performed arthroscopic knee surgery on the plaintiff. Following surgery, the doctor prescribed a cryotherapy device for the plaintiff to use at home to help control pain and swelling. The device worked by creating a flow of cold water across the plaintiff’s bandaged knee. The doctor and his staff instructed the plaintiff to use the device continuously for the first seventy-two hours after surgery and as needed thereafter, and to contact the doctor with any “issues” involving “drainage, redness, [or] warmth.” Hopper, 2018 WL 2270839 at *2.

The plaintiff used the device for seventy-two hours and intermittently for the next several days. On the fifth day, he saw the defendant doctor for complaints of swelling and bleeding. The doctor reassured the plaintiff that fluid buildup was common after surgery, aspirated the fluid from the knee, and instructed the plaintiff to return in a week. When the plaintiff returned, fluid had accumulated again, and the knee was painful. The doctor drained the fluid, but, he testified, was not “overly concerned.” He instructed the plaintiff to continue to use the device as needed.

Over the next several weeks, the plaintiff developed increased pain and swelling along with black skin and blisters on the knee. About five weeks after surgery, the plaintiff went to the emergency room complaining of nausea and increased knee pain. He was admitted, and ended up remaining in the hospital for a number of weeks. At the time of admission, the plaintiff had “eschar” – dead, necrotic tissue – over a wound in his knee. The eschar was surgically debrided, but it returned. Ultimately, the plaintiff was diagnosed with osteomyelitis, an infection of the bones in his knee. He was in danger of losing his leg, though doctors were able to save the leg by fusing the plaintiff’s knee.

The plaintiff sued the doctor for medical malpractice, alleging that the doctor deviated from the accepted standard of care during the postoperative period and that the deviations proximately caused his injuries. At trial, the plaintiff’s experts testified that the cryotherapy device caused “freezer burn” – a thermal injury – to the plaintiff’s skin, which the doctor did not recognize. According to the plaintiff’s experts, the untreated thermal injury destroyed the skin on the plaintiff’s knee. When the knee was debrided, the plaintiff’s experts testified, bacteria in the hospital environment infected the knee and eventually the bones, necessitating the fusion. The plaintiff’s experts testified that the doctor deviated from the standard of care by, inter alia, failing to warn the plaintiff of the risk of thermal injury and failing to personally instruct the plaintiff on how to use the cryotherapy device instead of allowing his staff to perform this task.

The defendant’s infectious disease expert opined, based on testing performed on tissue removed from the plaintiff’s knee, that the plaintiff was suffering from bullous cellulitis, blistering caused by a staph infection of the knee – not a thermal injury – when he presented to the emergency room, and that the infection would have occurred whether or not the plaintiff used the cryotherapy device. The defendant’s “standard of care” expert conceded that the doctor deviated from the accepted standard of care when he failed to warn the plaintiff of the risk of thermal injury. He testified that it was more likely than not that the plaintiff had sustained a thermal injury, but he did not opine that such injury was the proximate cause of the plaintiff’s damages.

The jury agreed, finding that the defendant had deviated from the applicable standard of care but that the deviations were not the proximate cause of the plaintiff’s injuries. On appeal, the plaintiff argued, inter alia, that, because it was ruled that the learned intermediary doctrine applied (the medical device manufacturer was no longer in the case when it was tried) and because there was sufficient evidence that thermal injury was a risk, the trial court committed error by failing to charge the jury about informed consent. The plaintiff argued that this error was “clearly prejudicial [because] defendant admitted he did not warn plaintiff of the risk of thermal injury.” Id. at *16.

The court disagreed, distinguishing between the product liability concept of “learned intermediary” and the medical monitoring theory of informed consent, explaining that “to prove a physician was negligent premised upon a theory of lack of informed consent, a plaintiff must show (1) the physician failed to comply with the applicable standard for disclosure; (2) the undisclosed risk occurred and harmed the plaintiff; (3) a reasonable person under the circumstances would not have consented and submitted to the [procedure] had he . . . been so informed; and (4) the [procedure] was a proximate cause of plaintiff’s injuries. Id. at *17 (citation omitted).

In any event, the court concluded that, because the jury had found that the doctor’s deviations from the standard of care were not the proximate cause of the plaintiff’s damages, the court’s failure to charge the jury on informed consent was harmless error. Verdict affirmed, and doctor off the hook for failing to warn. Wish it were that easy for the mother of a certain software engineer.