Many things look good at first, and then not so much after you look closer. “As seen on TV” is never as good as “as seen in person.” On TV, the Sham WoW is like a shammy, a towel, a sponge. It cleans the house, the car, the boat, the RV. Why even think of throwing away $20 a month on paper towels. In person, on the other hand, it’s an absorbent towel.  You wonder why you thought you could clean you entire house and yard with it.

The qui tam plaintiff in Integra Med Analytics, LLC v. Baylor Scott & White Health, 2019 WL 3713756 (W.D. Tex. Aug. 5, 2019), filed a complaint that looked good at first too. It alleged that the defendants—a hospital operator and four of its hospitals—ran a scheme to “upcode” Medicare diagnostic codes on patient illnesses resulting in Medicare claims with secondary diagnostic coding of a “Complication or Comorbidity” (“CC”) or a “Major Complication or Comorbidity” (“MCC”), which increased the amount of Medicare reimbursement paid to defendants. Id. at 1. To accomplish this, according to plaintiff, defendants implemented a Clinical Documentation Improvement program. Id. at 2 They emphasized coding for MCCs to their doctors. Id. They trained doctors and staff to use key words to trigger an MCC. Id. They circulated a list of MCCs on which staff diagnoses should focus. Id. They used employees with lists of MCCs to find opportunities to assign MCCs as secondary patient diagnoses. Id. They distributed tip sheets on how to document a diagnosis so that it is “codable.” Id. They sent doctors “queries” that encouraged them to “specify” or amend their initial diagnoses to subsequently include an MCC or CC. Id. They stressed to their doctors the importance of MCC coding to revenue and to a doctor’s performance evaluation. Id. Their intent, plaintiff alleged, was to influence doctors to “upcode” to higher paying MCC or CC claims. Id. As a result of this scheme, according to plaintiff, defendants’ frequency of coding patients with MCC diagnoses was significantly higher than that of their peers. Id. Plaintiff also presented a statistical analysis showing that this higher frequency was not due to a unique patient population. Id. It was, according to plaintiff, due to a fraudulent scheme that violated the False Claims Act. Id. at 3. It was a Sham.

Upon closer review, however, plaintiff hadn’t actually made allegations of fraud, or at least allegations that satisfied pleading requirements. Instead, the alleged scheme was consistent with a process to increase revenue through accurate coding of proper services. The court recognized this on defendants’ motion to dismiss, pointing to the publisher of the Medicaid codes, an entity called the Center of Medicare and Medicaid Services (“CMS”), which included in its publications encouragement of hospitals to code accurately and focus their coding documentation on maximizing Medicaid reimbursement:

[The scheme alleged by plaintiff] is not in and of itself one to submit false claims and is equally consistent with a scheme to improve hospital revenue through accurate coding of patient diagnoses in a way that will be appropriately recognized and reimbursed by CMS commensurate with the type and amount of services rendered.

CMS “encourage[s] hospitals to engage in complete and accurate coding” and has “reaffirm[ed its] view that hospitals focus their documentation and coding efforts to maximize reimbursement.” Medicare Program, Changes to the Hospital Inpatient Prospective Payment systems and Fiscal Year 2008 Rates, 72 FR 47130, 471817. CMS is well aware of the existence of hospital “methods for improving clinical documentation in order to increase reimbursement” and that hospitals “utiliz[e] clinical documentation specialists that work on the hospital treatment floors to encourage improvements in clinical documentation” to “improve coding and increase payment.” Id. at 47182.

Moreover, CMS has directly disavowed “the notion … that CMS believes changes in how services are documented or coded that [are] consistent with the medical record [are] inappropriate or otherwise unethical.” Id. at 47181. CMS does “not believe there is anything inappropriate, unethical or otherwise wrong with hospitals taking full advantage of coding opportunities to maximize Medicare payment that is supported by documentation in the medical record.” Id. CMS was fully aware that hospitals would “change their documentation and coding practices and increase case mix consistent with the payment incentives that are provided by the” then newly implemented MS-DRG system and fully supported this practice. Id. at 47182.

Id. at *4. In other words, a closer look found that plaintiff’s fraud allegations didn’t do as much as you’d thought at first. They didn’t actually allege fraud: “the mere fact that Defendants took targeted steps to increase their coding of CCs and MCCs to increase hospitals revenues is neither fraudulent, nor improper per se.” Id.

Allegations that are equally consistent with a program to improve coding accuracy while seeking maximum Medicare reimbursement are insufficient to state a fraud claim:

Plaintiff’s allegations are equally consistent with the conclusion that Defendants were taking steps to improve the accuracy and consistency of their medical documentation and coding so as to align it with terminology that CMS would recognize and reimburse appropriately. Where a complaint pleads facts that are merely consistent with a defendant’s liability, it stops short of the line between possibility and plausibility of entitlement to relief.

Id. at 5. (citations omitted).

Similarly, plaintiff’s statistical analysis was equally consistent with defendants simply being better than their peers at identifying and using accurate coding to maximize reimbursement:

Plaintiff’s statistical analysis allegedly demonstrating that no other explanation but fraud accounts for the data it analyzed overlooks one major alternative hypothesis: Defendants were simply better than their peers in their efforts to ensure their medical documentation and coding maximized the opportunities for legitimate reimbursement from CMS. Ultimately, Plaintiff’s allegations are not only compatible with but arguably more likely explained by lawful conduct. In such instances, Rule 8 has not been satisfied.

Id. at 6 (citations omitted).

You don’t need to return the Sham WoW. It’s still a towel. It’s still absorbent. It still works. You just can’t use it to clean your entire house and yard. Similarly, plaintiff’s allegations, for the most part, seem to describe a program put in place by defendants. They just don’t describe fraud. The court dismissed plaintiff’s complaint with prejudice. Id.

We write today about a partial exclusion of a plaintiff expert in the upcoming Taxotere bellwether trial. We have blogged about other aspects of the Taxotere litigation previously. (Here and here, for example.) The case is In re Taxotere (Docetaxel) Prods. Liability Litig., 2019 U.S. Dist. LEXIS 130339 (E.D. La. Aug. 5, 2019). Taxotere is used to treat chemotherapy. The plaintiff alleged that it caused her to suffer permanent hair loss. Her legal claims included, inter alia, failure to warn and misrepresentation. The defendants moved to limit or preclude a plaintiff expert’s opinions on a variety of issues, but the opinion we will focus on here is on how the medical community would have reacted to a different warning on the label. There was no dispute over whether the expert was qualified to render that opinion. Rather, the issue was whether that opinion would be helpful to the jury, given that the actual treating physician was available to testify about what he would have done if the label had been different.

It is interesting how the parties framed the issue. The plaintiff argued that the jury should be able to hear both the “objective” evidence from the expert, as well as the “subjective” evidence from the treating physician. Put that way, the position almost sounds reasonable. More evidence is always better than less, right? Um, no. Sometimes that more is more confusing and more prejudicial. The defendants argued that the jury must “hear it from the horse’s mouth” — that the learned intermediary doctrine “turns on the testimony of a plaintiff’s prescribing physician, not the testimony of a retained expert speculating about the decision-making process.” It is the effect on the actual treater that counts.

The horse’s mouth won over the objective/subjective framework. The Taxotere court ruled that the expert was not allowed to furnish testimony as to what the plaintiff’s treater would have done here. The expert could allude to “the standard of care for informing patients through the decision-making process; she cannot, however, testify about the application of these principles” to this particular case. Only the treater – who was available – could testify as to what he actually would have done.

This result is not surprising, inasmuch as it is the majority rule and is eminently reasonable. That the issue was even raised highlights the schizophrenia inherent in many product liability cases regarding treating physicians. Enterprising plaintiff lawyers would rather hang liability on deep-pocketed, unlovable corporations. Those plaintiff lawyers have less appetite for targeting doctors, who come garbed in white coats, oodles of respect, and state laws that cap med-mal damages. Even if the initial complaint names the treating physician as a defendant in order to prevent federal diversity jurisdiction, watch how the plaintiff soft-pedals discovery against the doctor, and then dismisses the claims against the doctor shortly before trial. Sometimes, to our cynical eyes, there is a whiff of a rotten quid pro quo behind such machinations.

Whether or not the treating physician was initially named in the complaint, the performance of the treating physician plays an important role in product liability actions. The plaintiff wants to make sure the jury assigns blame to the company, not the doctor. Thus, the plaintiff needs to say that the doctor did not err in selecting the product. That story is a bit jarring: the product stinks, but the doctor was wise to use it. Further, the plaintiff might accuse the company of failing to train physicians. But if the doctor did nothing wrong, of what significance is any alleged failure to train? Finally, and most pertinently for cases like this Taxotere case, the plaintiff needs to overcome the learned intermediary doctrine. That is not so easy when prescribing doctors say, as doctors usually do, that they were already aware of the relevant risk and the proposed enhanced warning would have made no difference. Or maybe the doctor confesses an inability to speculate about the counterfactual scenario. At this point the plaintiff tries to bring in an expert who essentially mouths the following: ‘I don’t care what the treater here says. Any reasonable doctor would have run far away from this product upon reading a proper label.’ That is, the expert is necessarily opining that the treater is a liar or an idiot. Jurors should not buy this contradictory tale-spinning by plaintiffs and their experts. Luckily, due to smart courts like the one in this Taxotere case, they do not have to.

Today we bring you a terrific Daubert defense win.  But, we’ll be honest it’s long.  Really long.  Thorough, but long.  So, we’re going to hit the highlights.

The case is Davis v. McKesson Corp., 2019 WL 3532179 (D. Ariz. Aug. 2, 2019).  It is a multi-plaintiff case against manufacturers and distributors of gadolinium-based contrast agents (“GBCA”) – used in MRIs.  GBCAs were the subject of an MDL several years involving allegations that when administered to patients with advanced kidney disease they caused a disease known as nephrogenic systemic fibrosis (“NSF”).  Id. at *2.  Plaintiffs in the current action allege that they have been exposed to GBCAs but that they do not have impaired kidneys and they have not been diagnosed with NSF.  Rather, they contend that after receiving GBCAs they developed “a range of symptoms [that] has not been recognized as a disease by regulatory authorities or medical associations, but the collection of symptoms has been referred to in some literature as “gadolinium deposition disease” (“GDD”).  Id.  In fact, the FDA convened an advisory committee in 2017 to explore the very issue of any connection between the retention of GBCAs in the body and the various symptoms reported by patients with healthy kidneys.  The board “unanimously concluded that the medical and scientific evidence does not establish that GBCAs cause GDD.”  Id. at *6.  Many other foreign regulatory bodies and medical societies have reached the same conclusion.  Id.

So, the court decided that the issue of general causation should be decided first and plaintiffs served expert reports from four experts, three on medical causation.  And if we had to sum it all up, what plaintiffs’ experts offer are “theories” or “hypotheses” – that still need to be tested – but are not reliable science that establish that the symptoms associated with GDD are an actual illness or that the illness is caused by GCBAs.  Id. at *10.  But, the court provides a lot more detail.

For instance, one of plaintiffs’ experts’ opinions is that GBCAs cause a “continuum” of symptoms the most severe of which cause NSF in renal impaired patients and less severe symptoms in patients with healthy kidneys.  Id. at *11.  This would basically impute the general medical causation of NSF to GDD because they are simply different ends of the same continuum.  “But this leap rests on nothing more than [plaintiff’s expert’s] say so.”  Id. at *12.

Plaintiffs try to bridge the gap by relying on case reports and surveys – the experiences of single patients without a formal study or control group.  Id. at *14.  But, “case reports are not reliable scientific evidence of causation,” id. at *14, and “[s]urveys are even less reliable.”  Id. at *15.  At least some case reports are made by physicians, whereas surveys “consist of unscreened answers from people who believe they suffer from GBCA-caused illnesses, often provided anonymously.”  Id.  All of plaintiffs’ causation experts relied on both case reports and surveys with no acknowledgement of their limitations.

From there, plaintiffs’ experts moved on to animal studies which while not inadmissible, “there must be a basis for extrapolating them to the human population.”  Id. at *16.  Plaintiffs’ experts did not provide any such basis.  In fact, several of the animal studies plaintiffs’ experts relied on involved rodents whose kidneys had been removed – making them less relevant to plaintiffs’ allegations that GBCAs cause GDD in humans with healthy kidneys.  Id.  The connection between the animal studies and plaintiffs’ experts’ opinions is based only on the experts’ “say-so.”  Id. at *17.

Plaintiffs’ experts similarly cite in vitro studies but do not discuss “the doses used in the studies or explain[] how those doses can reliably be extrapolated to the effects of GBCAs in humans with healthy kidneys.”  Id.  Further, plaintiffs’ experts’ “principles and methods for finding GBCA causation of GDD have not been accepted by other experts, regulatory bodies, or professional associations” and at least two of the experts “have not done [independent] research and their opinions appear to have been prepared solely for this litigation.”  Id.  Indeed, one of plaintiffs’ experts was a keynote speaker at the FDA advisory board where “he made several statements quite inconsistent with his current opinions” but nowhere in his report does he cite any data to support his changed opinions.  Id. at *25-26.

The bulk of the rest of the decision is filled with example after example of the specific ways in which plaintiffs’ experts fail in each of the above ways to satisfy the standard for admissibility under Daubert and Rule 702.  For instance:

  • Plaintiffs’ expert “never explains why the transfer of gadolinium from pregnant mice to their pups, or the accidental injection of GBCAs into the spinal canals of patients, or two case reports with their wide and differing range of symptoms can, through reliable scientific principles and methods, be extrapolated to show that GBCAs cause GDD in patients with healthy kidneys.” at *19
  • Plaintiffs’ expert “does not explain how the in utero exposure relates to patients with healthy kidneys, nor does he address why the in vitro study of skin growth, and its doses, can be reliably extrapolated to humans with no renal impairment.” at *22.
  • Plaintiffs’ expert “does not explain why case reports from NSF patients can reliably be applied to reach any conclusions, including conclusions regarding patients who have healthy kidneys and do not have NSF; why the use of a survey or the effects on a dog can be applied reliably to the same patients; or, for that matter, why heart, respiratory, and liver effects have anything to do with Plaintiffs, none of whom claim such ill effects.”
  • Plaintiffs’ expert “cites no evidence that retention in patients with normal renal function is equal in method or quantity to the accumulation in renally-impaired patients, and he merely assumes as probable that ‘tissue injury that occurs from GBCAs in renally impaired patients shares the same mechanisms of toxic injury with patients who have normal kidney function.’” Id. at *30.
  • Plaintiffs’ expert “offers only one-line conclusions summarizing the results of these studies with no explanation about why these studies can reliably be applied to the causation issue in this case or how they relate to his opinions.” at *31.

And then there is plaintiffs’ experts’ application of the Bradford Hill criteria.  The Bradford Hill criteria are used by epidemiologists in differentiating between a mere association and a causal connection.  While the court conducts a thorough analysis of all nine criteria, we really only need to examine the first one – strength of association.  An observed association is the starting point for the Bradford Hill analysis.  And the association that starts the analysis is normally an epidemiologic study – which plaintiffs admit doesn’t exist for the relation between GBCAs and GDD.  Id. at *33.  At best plaintiffs’ experts can cite the causal link between GBCA and NSF, but that doesn’t establish a relationship to GDD – and you can’t assume a relationship.  Id.

Finally, the court explains why plaintiffs’ case law doesn’t save their argument.  First, plaintiffs rely on Wendell v. GlaxoSmithKline, LLC, 858 F.3d 1227 (9th Cir. 2017) – one of our worst decisions that year and discussed in more detail here.  Fortunately, the court quickly distinguished it as a specific causation case and while we think there are many more reasons not to follow it, we’ll take it.  Davis, at *44-45.  Second, plaintiffs tried to analogize to the Daubert decision in the NSF MDL, but for all the reasons plaintiffs’ experts couldn’t rely on NSF science, the court wasn’t going to rely on NSF law.  Id. at *45.

The court gave the parties two weeks to submit a “plan” for what happens next.  Without an expert on general causation, the only route we see as viable is dismissal.

We recently blogged about the final chapter (at the district court level, anyway) of the big defense win in the Mirena MDL.  The long-overdue result was entry of summary judgment for the defendant against all claims.  As the blog also chronicled, the key Mirena decision had been earlier – and was already appealed and affirmed – Daubert required exclusion of the plaintiffs’ general causation experts.

We’re not revisiting that today.  However, in reading the recent opinion, though, we noticed this:

As an appendix to its submissions in support of its motion for summary judgment, [defendant] has supplied citations to hundreds of cases from . . . 53 jurisdictions. . . .   [Defendant] cites this authority to support . . . the argument[s] . . . that general causation is an element of complex products liability tort claims, and . . . that general causation in such cases requires proof in the form of expert testimony. . . .  The Court is persuaded that every jurisdiction requires a showing of general causation in cases, like this one, in which a plaintiff alleges that the use of a product gave rise, through a complex causal mechanism, to a medical injury or impairment.

In re Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II), ___ F. Supp.3d ___, 2019 WL 2433552, at *9 n.2 (S.D.N.Y. June 11, 2019) (emphasis added).

Well, well well. . . .  A collection of cases requiring expert testimony in “complex” causation product liability cases from 53 jurisdictions?   Sounds like something right up the DDLaw Blog’s alley.  It’s a publicly filed document, we have a PACER account, and we know how to use it.  So we located and downloaded the aforementioned appendix, and used it as the starting point for this post – and it was a very good starting point, indeed (kudos to defense counsel’s research) – for the 50-state survey that follows.

We’ve endeavored to collect as many no-expert prescription medical product liability litigation dismissals as we could find, as well as similar decisions in other product liability and toxic tort cases.  Along with selected caselaw from every state, we’ve produced fifty states’ worth of precedent that, we hope, means that none of our clients will ever have to start from scratch again, should they feel the need to present similar research in support of the expert witness requirement that prevailed in Mirena – that all states require dismissal of prescription medical product liability plaintiffs who lack admissible expert witnesses.

To start, we found a number of cases, some mentioned in the Mirena opinion, holding broadly that “every state in the union” – or some equivalent phrase − require expert-based evidence in complex product liability cases, concern causation and/or defect issues.  First, of course, there is Mirena itself:  “all relevant jurisdictions require some evidence of general causation in products liability cases involving complex products liability (or medical) issues.”  2019 WL 2433552, at *9.

It is well established that expert testimony is required to establish causation where the issue of causation is beyond the knowledge of lay jurors.  Other courts, surveying the law of the 50 states and territories, have concluded that each jurisdiction typically adheres to this principle.

*          *          *          *

[G]enerally in products liability cases involving complex causation issues, including cases involving pharmaceuticals or medical devices, to establish causation, plaintiffs must offer admissible expert testimony regarding both general causation and specific causation. There are many holdings in accord.

Id. at *11-12 (citations and quotation marks omitted).

[A]ll jurisdictions have a similar rule requiring expert testimony where a matter is outside the ken of an ordinary lay juror.  Because [the product] is a medical device and the theory of secondary perforation is a concept requiring a nuanced understanding of . . . anatomy, the Court has no serious doubt that all jurisdictions would treat this issue as one requiring expert testimony to prove causation.

In re Mirena IUD Products Liability Litigation, 202 F. Supp.3d 304, 313 (S.D.N.Y. 2016), aff’d, 713 F. Appx. 11, 16 (2d Cir. 2017) (“Plaintiffs have not identified any state that does not require expert testimony in the circumstances at issue here”).  See also Barnes v. Anderson, 202 F.3d 150, 159 (2d Cir. 1999) (“[t]he requirement that plaintiffs produce expert medical evidence in order to prove proximate causation of medical injury also is often expressed”) (applying federal law); In re Lipitor Marketing, Sales Practices & Products Liability Litigation, 227 F. Supp.3d 452, 469 (D.S.C. 2017) (“While the specific language used by courts varies to some degree, all jurisdictions require expert testimony at least where the issues are medically complex and outside common knowledge and lay experience.”); In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation, 226 F. Supp.3d 557, 569-70 (D.S.C. 2017) (same); In re Zoloft (Sertraline hydrochloride) Products Liability Litigation, 176 F. Supp.3d 483, 490 (E.D. Pa. 2016) (“Plaintiffs have not cited cases from any jurisdiction holding that the complex scientific question of whether a prescription drug is a teratogen can be answered without expert testimony or based on circumstantial evidence, and the legal principles upon which the Court has relied tend to be consistent across jurisdictions.”), aff’d, 858 F.3d 787 (3d Cir. 2017); In re Bausch & Lomb, Inc. Contacts Lens Solution Products Liability Litigation, 693 F. Supp.2d 515, 518 (D.S.C. 2010) (Under the law of “all the applicable jurisdictions,” “plaintiffs’ claims cannot survive” after “plaintiffs’ only general causation expert, has been excluded.”), aff’d, 429 F. Appx. 249 (4th Cir. 2011); In re Rezulin Products Liability Litigation, 441 F. Supp.2d 567, 575 & n.68 (S.D.N.Y. 2006) (expert causation testimony in prescription medical product liability litigation “is a requirement in every state in which these plaintiffs have brought their claims”); In re Phenylpropanolamine (PPA) Products Liability Litigation, 2003 WL 27382559, at *1 (W.D. Wash. Oct. 24, 2003) (“Given the medically and scientifically complex nature of this litigation, expert testimony is crucial to the establishment of causation.”); In re Norplant Contraceptive Products Liability Litigation, 215 F. Supp.2d 795, 830, 833 (E.D. Tex. 2002) (“[e]vidence of general causation must be provided in the form of expert testimony”; summary judgment granted; “Plaintiffs have not produced a shred of evidence or expert testimony that supports an association between Norplant and any of the [more than 950] exotic conditions”).


Anyway, as our research often does, this project became much more substantial than we originally expected.  The law was more extensive than we thought, and to do it justice required going beyond prescription medical product liability litigation.  So in order not to overwhelm our readers with too much at once, we’ve decided to break this 50-state survey – at least initially – into three roughly equal parts.  Part one is Alabama through maritime law.


Under Alabama law, expert testimony is required to establish causation where “the nature and origin” of the injury is “beyond the understanding of the average person.”  Ex parte Trinity Industries, Inc., 680 So.2d 262, 269 (Ala. 1996).  Thus, “[p]laintiffs must prove the toxicity of [a product] and that it had a toxic effect on them causing the injuries that they suffered,” and “[t]his type of proof requires expert testimony.”  McClain v. Metabolife International, Inc., 401 F.3d 1233, 1237 (11th Cir. 2005) (applying Alabama law).

The interaction between a complex and technical medical device and the unique physiological and medical circumstances of the patient in which it is implanted is a subject on which no ordinary juror could rationally be expected to have knowledge.  The net result is that, without the benefit of expert testimony, a reasonable jury could not possibly make a determination . . . that [plaintiff’s] injuries were caused by a . . . defect in the [product].

Hughes v. Stryker Sales Corp., 2010 WL 1961051, at *5 (S.D. Ala. May 13, 2010), aff’d, 423 F. Appx. 878, 881 (5th Cir. 2011) (on basis of district court’s reasoning).  “[I]n the typical case involving a complex medical device, the absence of expert testimony would force a jury to engage in speculation and conjecture on issues of defect and causation,” thus “courts routinely require expert testimony in such matters.”  Id.

Thus, “Alabama courts consistently have opined that . . ., when the product at issue is of a complex and technical nature, the plaintiff’s proof of a defect should be in the form of expert testimony. Bloodsworth v. Smith & Nephew, Inc., 476 F. Supp.2d 1348, 1353 n.3 (M.D. Ala. 2006).  See Drake v. Ortho-McNeil-Janssen Pharmaceuticals, 2018 WL 1431646 (N.D. Ala. March 22, 2018) (“[d]ue to the complex nature of the claims, expert testimony generally is required to establish general and specific causation in product liability cases”); Brantley v. International Paper Co., 2017 WL 2292767, at *16 (M.D. Ala. May 24, 2017) (“The plaintiffs must establish both general and specific causation through expert evidence.”); Jones v. Novartis Pharmaceuticals Corp., 2017 WL 553134, at *17 (N.D. Ala. Feb. 10, 2017) (“plaintiffs must provide expert testimony to establish both general and specific causation”), aff’d, 720 F. Appx. 1006 (11th Cir. 2018); Benkwith v. Matrixx Initiatives, Inc., 467 F. Supp.2d 1316, 1332 (M.D. Ala. 2006) (plaintiff “must present expert evidence on general causation.  Without proof of causation, she cannot prevail”) (citation omitted); Sutherland v. Matrixx Initiatives, Inc., 2006 WL 6617000, at *14 (N.D. Ala. 2006) (“without an expert to connect a toxin to an injury, there is no toxic tort”); Emody v. Medtronic, Inc., 238 F. Supp.2d 1291, 1295 (N.D. Ala. 2003) (“An essential element of all product liability cases is expert testimony . . . that a defect was the medical cause of plaintiff’s claimed injuries.”).


Expert testimony is required in Alaska to establish a causal connection “where there is no reasonably apparent . . . causal relationship between the event demonstrated and the result sought to be proved.”  Choi v. Anvil, 32 P.3d 1, 3 (Alaska 2001) (citation and quotation marks omitted).  This question is one “of law to which we apply our independent judgment.”  D.P. v. Wrangell General Hospital, 5 P.3d 225, 228 (Alaska 2000).  Thus, a plaintiff is “required by law to support his claim with expert testimony unless the causation of his alleged injury was of a non-technical nature.”  Parker v. Tomera, 89 P.3d 761, 766 (Alaska 2004).  See Voyles v. State, 2008 WL 4951416, at *18 (Alaska App. Nov. 19, 2008) (“The test is whether the basis of the [casual] conclusion (once explained) can be readily understood and assessed by lay jurors.”); Coppe v. Bleicher, 2008 WL 8614177 (Alaska Super. Aug. 29, 2008) (“Expert testimony is required to establish medical causation when the nature and character of a person’s injuries require the special skill of an expert to render the evidence comprehensible.”); Gallant v. United States, 392 F. Supp.2d 1077, 1080-81 (D. Alaska 2005) (expert testimony required in any case that “is not a situation where negligence could be evident to a lay person”) (footnote omitted).


In Arizona litigation, “[w]hen [a] causal connection is not readily apparent, it must be established by expert medical testimony”  Aguayo v. Industrial Commission, 333 P.3d 31, 33-346 (Ariz. App. 2014).  Thus, “[w]here causation is peculiarly within the knowledge of medical experts . . . we must rely upon the opinion of medical experts.”  McNeely v. Industrial Commission, 501 P.2d 555, 557 (Ariz. 1972).  “Expert medical testimony is . . . generally required to establish proximate cause unless a causal relationship is readily apparent to the trier of fact.”  Rasor v. Northwest Hospital, LLC, 373 P.3d 563, 566 (Ariz. App. 2016), rev’d on other grounds, 403 P.3d 572 (Ariz. 2017) (holding plaintiff’s expert unqualified).  See also Clemens v. DMB Sports Clubs Ltd. Partnership, 2015 WL 8166584, at *3 (Ariz. App. Dec. 8, 2015) (“the plaintiff must prove the cause of . . . physical injury damages through expert medical testimony, unless a causal relationship is readily apparent to the trier of fact”) (citation and quotation marks omitted); Gentry v. Daugherity, 2015 WL 1346097, at *3 (D. Ariz. March 24, 2015) (“Unless an injury is obvious to the jury, expert medical testimony is required to establish the nature and extent of the injury as well as its relationship to the accident.”); Cloud v. Pfizer, Inc., 198 F. Supp.2d 1118, 1138-39 (D. Ariz. 2001) (a plaintiff “cannot prove causation” “in the absence” of expert testimony).


Arkansas requires expert testimony regarding causation in the “vast majority of our cases” where it involves medical issues that are “not within the comprehension of a jury of laymen.”  Mitchell v. Lincoln, 237 S.W.3d 455, 599 (Ark. 2006).  “Except in the most obvious cases, such causation must be established by expert medical testimony.”  Baldwin v. Club Products Co., 604 S.W.2d 568, 570 (Ark. App. 1980).  Where a plaintiff’s “alleged resulting injuries involved complex medical issues outside the jury’s common knowledge, . . . expert testimony was necessary.”  Engleman v. McCullough, 535 S.W.3d 643, 649 (Ark. App. 2017).

In product liability “to prove a defect by showing a safer alternative design . . . [plaintiff] could not meet his burden without an expert.”  Anderson v. Raymond Corp., 340 F.3d 520, 524 (8th Cir. 2003) (applying Arkansas law).  Thus, “Whether proceeding on a negligence or strict liability theory, a plaintiff in a toxic tort case must, under Arkansas law, establish medical causation through expert testimony.”  National Bank of Commerce v. Associated Milk Producers, Inc., 22 F. Supp.2d 942, 949 (E.D. Ark. 1998), aff’d, 191 F.3d 858 (8th Cir. 1999).  “Under Arkansas law, expert witness testimony is required to prove that any negligence of Defendants was a proximate cause of Plaintiff’s injuries, as Plaintiff in this case alleged medical injuries based on a theory that involved complex determinations of medical issues.”  Isham v. Booneville Community Hospital, 2015 WL 4133098, at *2 (W.D. Ark. July 8, 2015).


California law establishes that “the decisive consideration in determining the necessity of expert opinion evidence is whether the subject of inquiry is one of such common knowledge that persons of ordinary education could reach a conclusion as intelligently as the witness or whether, on the other hand, the matter is sufficiently beyond common experience that the opinion of an expert is required.”  Campbell v. General Motors Corp., 649 P.2d 224, 231 (Cal. 1982).  “In cases like the one before us, presenting complicated and possibly esoteric medical causation issues, the standard of proof ordinarily required is ‘a reasonable medical probability based upon competent expert testimony that the defendant’s conduct contributed to [the] plaintiff’s injury.’”  Bockrath v. Aldrich Chemical Co., 980 P.2d 398, 403 (Cal. 1999) (quoting Rutherford v. Owens-Illinois, Inc., 941 P.2d 1203, 1219 n.11 (Cal .1997)).  Where “the complexity of the causation issue is beyond common experience, expert testimony is required to establish causation.”  Stephen v. Ford Motor Co., 37 Cal. Rptr.3d 9, 17 (Cal. App. 2005).  See Miranda v. Bomel Construction Co.,. 115 Cal. Rptr.3d 538, 545-46 (Cal. App 2010) (“The law is well settled that in a personal injury action causation must be proven within a reasonable medical probability based upon competent expert testimony.”); People v. Racy, 56 Cal. Rptr.3d 455, 460 (2007) (“expert testimony would have been necessary because the effects of [the product] . . . are matters beyond the experience of average jurors”); Jones v. Ortho Pharmaceutical Corp., 209 Cal. Rptr. 456, 461 (Cal. App. 1985) (“the unknown and mysterious etiology of cancer” is “beyond the experience of laymen and can only be explained through expert testimony”).

Thus, “In California, ‘in a personal injury action causation must be proven within a reasonable medical probability based upon competent expert testimony.’”  Avila v. Willits Environmental Remediation Trust, 633 F.3d 828, 836 (9th Cir. 2011) (quoting Jones, 209 Cal. Rptr. at 460).

The law is well-settled that in a personal injury action causation must be proven within a reasonable medical probability based upon competent expert testimony.  And where, as here, the complexity of the causation issue is beyond common experience, expert testimony is required to establish causation.

Brown v. Johnson & Johnson, 2019 WL 2577296, at *5 (E.D. Cal. June 24, 2019) (citations and quotation marks omitted).  See Nelson v. Matrixx Initiatives, Inc., 592 F. Appx. 591, 592 (9th Cir. 2015) (“General and specific causation” “must be proven within a reasonable medical probability based upon competent expert testimony.”) (also quoting Jones) (applying California law); Pierson v. Ford Motor Co., 445 F. Appx. 966, 968 (9th Cir. 2011) (quoting Stephen) (applying California law); In re Baycol Products Litigation, 596 F.3d 884, 889 (8th Cir. 2010) (“To succeed in his strict liability and negligence claims, [plaintiff] has the burden of proving medical causation through the use of a medical expert.”) (citing Bockrath) (applying California law); Shalaby v. Newell Rubbermaid, Inc., 379 F. Appx. 620, 623 (9th Cir. 2010 (where “the plaintiffs had not presented the expert testimony required to establish causation . . ., the plaintiffs had not established a prima facie case”) (quoting Stephen) (applying California law); Viramontes v. Pfizer, Inc., 2018 WL 3363699, at *9 (E.D. Cal. July 10, 2018) (“The applicable law requires that ‘in a personal injury action causation must be proven within a reasonable medical probability based upon competent expert testimony.’”) (also quoting Jones); Sclafani v. Air & Liquid Systems Corp., 14 F. Supp.3d 1351, 1355 (C.D. Cal. 2014) (issues of causation “beyond the experience of laymen . . . can only be explained through expert testimony”); Thomas v. Abbott Laboratories, 2014 WL 4197494, at *11 (C.D. Cal. July 29, 2014) (“Where causation is beyond a jury’s experience, it is the expert who must rule out the other possible causes.”); Sanchez v. Stryker Corp., 2012 WL 1570569 at *6 (C.D. Cal. May 2, 2012) (“Probable causes in a medical tort case are beyond the experience of laymen and can only be explained through expert testimony.”); Cox v. Depuy Motech, Inc., 2000 WL 1160486, at *7 (S.D.Cal. March 29, 2000) (“Because plaintiff does not have an expert who can establish medical causation, an essential element of a products liability claim, plaintiff cannot withstand defendant’s motion for summary judgment on the issue of causation.”); Huntman v. Danek Medical, Inc., 1998 WL 663362, at *3–4 (S.D.Cal. July 24, 1998) (“[i]n the absence of expert testimony . . . plaintiff’s strict liability and negligence claims must fail”); Sanderson v. International Flavors & Fragrances, Inc., 950 F. Supp. 981, 985 (C.D. Cal. 1996)  (“It should be emphasized that expert testimony is required to establish causation, since this case involves scientific issues that are beyond the experience of laymen.”).


Under Colorado law, when “the applicable standard is not within the common knowledge and experience of ordinary persons, the applicable standard must be established by expert testimony.”  United Blood Services, a Div. of Blood Systems, Inc. v. Quintana, 827 P.2d 509, 520 (Colo. 1992).  Expert testimony is required for any “complex medical question outside lay competence.”  Mathison v. United States, 619 F. Appx. 691, 694 (10th Cir. 2015) (applying Colorado law).

Thus, “[u]nder Colorado law, products liability claims involving matters outside the experience of the average layperson, like negligence claims involving such complex or technical issues, require expert testimony to prove issues such as causation.”  Xtreme Coil Drilling Corp. v. Encana Oil & Gas (USA), Inc., 2010 WL 3777303, at *7 (D. Colo. Sept. 19, 2010).  Thus, Colorado law “require[s] expert witness testimony to establish the causal link between complex injuries and [an] incident.”  Sanchez-Ironshell v. Brinker Restaurant Corp., 2017 WL 5990090, at *3 (D. Colo. June 15, 2017).  See Truck Insurance Exchange v. MagneTek, Inc., 360 F.3d 1206, 1215 (10th Cir. 2004) (“without the excluded expert testimony . . ., a jury could not reasonably make the necessary inference that the [product] caused the [accident]”) (applying Colorado law); Brown v. Johnson & Johnson, 2016 WL 897021, at *1 (D. Colo. March 9, 2016) (“these injuries were allegedly caused by chemicals working within [plaintiff’s] body.  A lay jury does not have the competence to conclude, based on everyday experience, that [a drug] in fact caused [plaintiff’s] injuries.”); Howell v. Centric Group, LLC, 2011 WL 4499372, at *5 (D. Colo. Sept. 27, 2011) (“where questions of causation are beyond the knowledge and experience of ordinary persons, expert testimony may be required”), aff’d, 508 F. Appx. 834, 836 (10th Cir. 2013) (“[w]here an injury has multiple potential etiologies, expert testimony is necessary to establish causation”) (citation and quotation marks omitted) (applying Colorado law).


In Connecticut, “[i]f lay witnesses and common experience are not sufficient to remove the case from the realm of speculation, the plaintiff will need to present expert testimony to establish a prima facie case.”  Metropolitan Property & Casualty Insurance Co. v. Deere & Co., 25 A.3d 571, 584 (Conn. 2011).  Thus, “[d]epending on the type of product at issue − namely, its complexity − expert testimony regarding product defect or causation may be required in order to make out a prima facie product liability case.”  D’Ascanio v. Toyota Industrial Corp., 72 A.3d 1019, 1026 (Conn. 2013).  Accord Bagley v. Adel Wiggins Group, 171 A.3d 432, 447 (Conn. 2017) (“proof [of asbestos exposure] required the assistance of an expert because the subject matter was technical in nature and beyond the field of ordinary knowledge of a lay juror.  Because the plaintiff did not produce an expert, she failed to prove her case.”); Santopietro v. City of New Haven, 682 A.2d 106 (Conn. 1996) (“If the determination of the standard of care requires knowledge that is beyond the experience of an ordinary fact finder, expert testimony will be required.”).

“When the causation issue involved goes beyond the field of ordinary knowledge and experience of judges and jurors, expert testimony is required.”  Theodore v. Lifeline Systems Co., 163 A.3d 654, 666 (Conn. App. 2017) (citation and quotation marks omitted).  “[W]e . . . consistently have held that expert testimony is required when the question involved goes beyond the field of the ordinary knowledge and experience of judges or jurors.”  White v. Mazda Motor, Inc., 54 A.3d 643, 650 (Conn. App. 2012) (citation and quotation marks omitted), aff’d, 99 A.3d 1079 (Conn. 2014).

Proof that a defect in the product caused the injury in controversy is a prerequisite to recovery for product-caused injury in every products liability case. . . .  When the causation issue involved goes beyond the field of ordinary knowledge and experience of judges and jurors, expert testimony is required.  The product at issue in the present case is a complex product:  a spinal system . . . implanted into the patient’s spine. . . .  Accordingly, we agree with the trial court’s determination that expert testimony was required to establish causation.

Ferrari v. Johnson & Johnson, Inc., ___ A.3d ___, 2019 WL 2167849, at *6 (Conn. App. May 21, 2019).  Accord Milton v. Robinson, 27 A.3d 480, 493 (Conn. App. 2011) (expert testimony mandatory in case that “concerns complex details regarding the adequacy of a phase III clinical study and standards of care in designing experimental drugs”).

Thus, “Connecticut courts consistently hold ‘that expert testimony is required when the question involved goes beyond the field of the ordinary knowledge and experience of judges or jurors.’” Brown v. Johnson & Johnson Pharmaceuticals, 2015 WL 235135, at *3 (D. Conn. Jan. 16, 2015) (quoting White).  “[W]ithout expert medical testimony causally linking [the drug] to [plaintiff’s] injuries, a reasonable jury could not find that it is more probable than not that [the drug] caused [those] injuries.”  Id. at *4.  See Grenger v. General Electric Co., 2019 WL 2743577, at *2 (D. Conn. July 1, 2019) (entering summary judgment because “[w]ithout competent expert testimony, plaintiff will be unable to demonstrate” exposure); Beyer v. Anchor Insulation Co., 238 F. Supp.3d 270, 294 (D. Conn. 2017) (“The complexity of the causal link between [the product] and Plaintiffs’ health problems necessitates expert testimony as to general causation.”); K.E. v. GlaxoSmithKline LLC, 2017 WL 440242, at *26 (D. Conn. Feb. 1, 2017) (summary judgment granted in prescription medical product liability case after plaintiffs’ experts excluded); Sullivan v. Pfizer, Inc., 2016 WL 868155, at *4 n.4 (D. Conn. March 4, 2016) (“Because prescription drugs and their effects on the human body are complex issues, Sullivan cannot avoid the need for expert testimony by relying on the doctrine of res ipsa loquitur.”); Walters v. Howmedica Osteonics Corp., 676 F. Supp.2d 44, 52 (D. Conn. 2009) (“the standard of care that the designer and manufacturer of [a medical device] must follow lay beyond the experience and ken of the ordinary fact finder”; summary judgment entered for lack of expert testimony) (citation and quotation marks omitted); Koger v. Synthes North America, Inc., 2009 WL 5110780, at *3 (D. Conn. Dec. 17, 2009) (“plaintiff’s proof of defect and causation involves complex issues, requiring expert testimony”); Gold v. Dalkon Shield Claimants Trust, 1998 WL 351456, at *3 (D. Conn. June 15, 1998) (“without a proffer of expert medical testimony as to causation to link the defect to the injury, a reasonable jury could not find that the plaintiff has proved that the defect caused her specific injuries”), aff’d, 189 F.3d 460 (2d Cir. 1999).


“It is settled Delaware law that, if a claim requires proof of facts that are “not within the common knowledge of laymen,” those facts “must be presented through competent expert testimony.”  Campbell v. DiSabatino, 947 A.2d 1116, 1118 (Del. 2008).  “When the plaintiff’s claim involves bodily injuries, the causal connection between the defendant’s alleged negligent conduct and the plaintiff’s alleged injury must be proven by the direct testimony of a competent medical expert.”  Roache v. Charney, 38 A.3d 281, 286 (Del. 2012).  “[I]f the matter in issue is one within the knowledge of experts only and not within the common knowledge of laymen, it is necessary for the plaintiff to introduce expert testimony in order to establish a prima facie case.”  Money v. Manville Corp. Asbestos Disease Compensatory Trust Fund, 596 A.2d 1372, 1375 (Del. 1991) (citations and quotation marks omitted).

If a party intends to make an argument involving an issue that is within the knowledge of experts only and not within the common knowledge of laymen, the party must present competent expert testimony to support that argument.  Expert testimony is required where a reasoned decision on the question of proximate cause may require understanding and analysis of issues beyond the ken of the typical jury.

Davis v. Maute, 770 A.2d 36, 40 n.3 (Del. 2001) (citations and quotation marks omitted).

Thus, “[i]n pharmaceutical cases such as this, involving complex scientific evidence, a plaintiff must present expert witnesses to provide evidence of both general and specific causation.”  Scaife v. Astrazeneca LP, 2009 WL 1610575, at *20 (Del. Super. June 9, 2009) (footnote omitted).  See Hopkins v. Janssen Pharmaceuticals, Inc., 2019 WL 1567840, at *2 (D. Del. April 11, 2019) (granting summary judgment because “Plaintiff cannot establish proximate cause, as a matter of law, because he has not produced an expert report”); Guinan v. A.I. duPont Hospital for Children, 597 F. Supp.2d 517, 533 (E.D. Pa. 2009) (summary judgment granted where plaintiff’s expert’s “report is devoid of an opinion regarding causation”) (applying Delaware law), aff’d, 393 F. Appx. 884 (3d Cir. 2010); Collis v. Topper’s Salon & Health Spa, Inc., 2013 WL 4716237, at *2 (Del. Super. Aug. 29, 2013) (“Medical expert testimony regarding causation is required when there is a claim for bodily injuries, regardless of the nature of the negligence involved.”); Gunzl v. Warner’s Moving & Storage, Inc., 1993 WL 331084, at *3 (Del. Super. Aug. 4, 1993) (“Medical testimony is necessary to establish causation between the accident and the alleged disability if the medical question becomes sufficiently complicated so that it is within the field of medical experts.”).

District of Columbia

District of Columbia litigants must produce expert testimony “in cases presenting medically complicated questions due to multiple and/or preexisting causes.”  Baltimore v. B.F. Goodrich Co., 545 A.2d 1228, 1231 (D.C. 1988).  “Our rule for medically complicated cases is that proof of causation normally requires medical opinion testimony.”  Lasley v. Georgetown University, 688 A.2d 1381, 1384 (D.C. 1997).  “In cases presenting medically complicated questions . . ., we have held that expert testimony is required on the issue of causation.”  Brin v. S.E.W. Investors, 902 A.2d 784, 793 (D.C. 2006) (quoting Williams v. Patterson, 681 A.2d 1147, 1150 (D.C. 1996)).

Federal courts apply the expert requirement to all defect and causation questions.  “D.C. law often requires expert testimony in tort cases even when the facts underlying the plaintiff’s injury might seem fairly straightforward.” Davis v. Bud and Papa, Inc., 885 F. Supp.2d 85, 89 (D.D.C. 2012).  See Westinghouse Electric Corp. v. Nutt, 407 A.2d 606, 612 (D.C. 1979) (“[t]he jury needed supporting expert testimony to assess the burden of precaution to avoid harm”); Kubicki v. Medtronic, Inc., 293 F. Supp.3d 129, 156 (D.D.C. 2018) (“in complex medical product liability cases such as this one, expert testimony regarding causation is ordinarily indispensable under District of Columbia law”); Arias v. DynCorp, 928 F. Supp.2d 1, 9 (D.D.C. 2013) (“Because the nexus between the plaintiffs’ exposure and their increased risk of cancer would not be obvious to the jury, expert evidence is required to explain the underlying medical science and avoid jury guesswork or speculation as to the issue of causation.”); Halcomb v. Woods, 610 F. Supp.2d 77, 85 (D.D.C. 2009) (“expert testimony is necessary to demonstrate a causal link between a defendant’s act and a plaintiff’s harm “in cases presenting medically complicated questions”); Willis v. Besam Automated Entrance Systems, Inc., 2005 WL 2902494, at *14 (E.D. Pa. Nov. 3, 2005) (“In order to prevail on a theory of strict liability, the plaintiff must rely on expert testimony when the subject presented is so distinctly related to some science, profession, business or occupation as to be beyond the ken of the average layman.”) (citation and quotation marks omitted) (applying District of Columbia law), aff’d in pertinent part, 228 F. Appx. 246 (3d Cir. 2007); Webster v. Pacesetter, Inc., 259 F. Supp.2d 27, 34 (D.D.C. 2003) (“even if they could identify a defect, [plaintiffs] have failed to proffer evidence from an expert who can testify to a reasonable degree of certainty that the defect more likely than not caused the injuries”).

First Nations

“The Navajo Nation Supreme Court has recognized the need for expert testimony where a layperson is not qualified to provide a reliable analysis.”  Harvey v. United States, 685 F.3d 939, 955 (10th Cir. 2012) (applying Navajo law).  “Diagnosis of an individual requires professional expertise; when such a diagnosis is used outside the context of its professional use it introduces the risks of mischaracterizations, inaccuracy and potential prejudice and bias.”  Baldwin v. Chinle Family Court, 2008 WL 5444666 (Navajo Oct. 30, 2008).


Florida “[t]oxic tort cases . . . are won or lost on the strength of the scientific evidence presented to prove causation.”  Rink v. Cheminova, Inc., 400 F.3d 1286, 1297 (11th Cir. 2005) (applying Florida law).  Expert testimony is necessary “to establish legal causation where the issue is beyond the common knowledge of laymen.”  Benitez v. Joseph Trucking, Inc., 68 So.3d 428, 431 (Fla. App. 2011); accord Gouveia v. Phillips, 823 So.2d 215, 227 (Fla. App. 2002) (expert testimony required “when the discrete issue to be decided is not within the abilities of lay jurors”).  Likewise, “the adequacy or inadequacy of the warning to inform a physician must, except in the more obvious situations, be proved by expert testimony.”  Upjohn Co. v. MacMurdo, 562 So.2d 680, 683 (Fla. 1990).

[I]n complex cases where a jury is asked to assess complex medical or scientific issues outside the scope of a layperson’s knowledge, an expert’s testimony is required. Without expert testimony, the plaintiff’s claim fails as a matter of law.

Small v. Amgen, Inc., 723 F. Appx. 722, 726 (11th Cir. 2018) (citations and quotation marks omitted) (applying Florida law).  See Chapman v. Procter & Gamble Distributing, LLC, 766 F.3d 1296, 1316 (11th Cir. 2014) (plaintiffs “were required to have Daubert-qualified, general and specific-causation-expert testimony”) (emphasis original) (applying Florida law); Kilpatrick v. Breg, Inc., 613 F.3d 1329, 1334 n.4 (11th Cir. 2010) (following McClain, see Alabama) (applying Florida law); Hendrix v. Evenflo Co., 609 F.3d 1183, 1203 (11th Cir. 2010) (“without this [expert] testimony there is no genuine dispute of material fact regarding causation . . . [and] the district court’s grant of summary judgment on [plaintiff’s] sole remaining claim was appropriate.”) (applying Florida law); Guinn v. AstraZeneca Pharmaceuticals LP, 602 F.3d 1245, 1256 (11th Cir. 2010) (“the exclusion of [plaintiffs’ expert’s] testimony is a basis for granting summary judgment”) (applying Florida law); In re Diet Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Products Litigation, 85 F. Appx. 845, 847 (3d Cir. 2004) (“under Florida law [plaintiff] must present expert testimony regarding causation in order to sustain his suit”) (applying Florida law); Tonelli v. NCL (Bahamas) Ltd., 2019 WL 935384 (S.D. Fla. Feb. 26, 2019) (“In Florida, cases involving complicated medical questions require expert opinions to establish causation.”); In re Abilify (Aripiprazole) Products Liability Litigation, 299 F. Supp.3d 1291, 1306 (N.D. Fla. 2018) (“To prevail in a pharmaceutical products liability case, a plaintiff must establish both general and specific causation through reliable expert testimony.”); Bryant v. C. R. Bard, Inc., 2017 WL 2350228, at *3 (S.D.W. Va. May 30, 2017) (with expert testimony stricken, plaintiff “has not produced any evidence to show medical causation”) (applying Florida law); Olmo v. Davol, Inc., 2017 WL 1367231, at *6-7 (S.D. Fla. April 10, 2017) (summary judgment on causation granted in medical device case after plaintiff’s experts excluded), aff’d, 710 F. Appx. 861 (11th Cir. 2018); Marshick v. Johnson & Johnson, 2015 WL 9266955, at *3 (M.D. Fla. Dec. 11, 2015) (“A plaintiff must prove general and specific causation by expert testimony.”); McCasland v. Pro Guard Coatings, Inc., 2018 WL 5786164, at *3 (M.D. Fla. Nov. 5, 2018) (plaintiff “must present expert testimony linking [the product] to his medical condition to meet this burden”); Payne v. C.R. Bard, Inc., 7, 2014 WL 1887297, at *2 (M.D. Fla. May 12, 2014) (“Expert testimony is generally necessary to prove that a complex product like a medical device is defective.”), aff’d, 606 F. Appx. 940 (11th Cir. 2015); Jacob v. Korean Air Lines Co., 2014 WL 1584444, at *6 (S.D. Fla. March 20, 2014) (“Although causation is an issue generally left to a jury, medical causation falls beyond the scope of a layperson’s knowledge and requires competent medical testimony.”); Faile v. Dillard’s Inc., 2011 WL 13192673, at *2 (N.D. Fla. Nov. 7, 2011) (“plaintiffs must introduce expert testimony to establish medical causation in Florida”), aff’d, 480 F. Appx. 951 (11th Cir. 2012); In re Trasylol Products Liability Litigation, 2011 WL 7109297, at *10 (S.D. Fla. April 27, 2011) (“Plaintiff must, but cannot, establish causation with competent expert testimony in this complex medical case.); Savage v. Danek Medical, Inc., 31 F. Supp.2d 980, 983 (M.D.Fla.1999) (“A defect must be proven by expert testimony”); Baker v. Danek Medical, 35 F. Supp.2d 875, 880 (N.D. Fla. 1998) (“An invitation to the jury to join in speculation is not sufficient medical causation testimony to defeat a summary judgment challenge.”).


Georgia law mandates expert testimony “where the existence of a causal link between the defendant’s conduct and the plaintiff’s injury cannot be determined from common knowledge and experience and instead requires the assistance of experts with specialized medical knowledge.”  Cowart v. Widener, 697 S.E.2d 779, 784 (Ga. 2010).  “[E]ven in simple negligence cases, plaintiffs must come forward with expert evidence . . . where ‘medical questions’ relating to causation are involved.”  Id.  “[T]oxic tort” cases are a another “example.”  Id. at 785.  “Causation is an essential element of a toxic tort case,” and proof of causation in such cases “generally requires reliable expert testimony.”  Butler v. Union Carbide Corp., 712 S.E.2d 537, 544 (Ga. App. 2011) (footnote omitted).  Thus, Georgia “[t]oxic tort cases . . . are won or lost on the strength of the scientific evidence presented to prove causation.”  Rider v. Sandoz Pharmaceuticals Corp., 295 F.3d 1194, 1197 (11th Cir. 2002).  See Barko Response Team, Inc. v. Sudduth, 795 S.E.2d 198, 201-02 (Ga. App. 2016) (reversible error to deny summary judgment where plaintiff submitted no expert evidence in toxic mold case); Seymour Electrical & Air Conditioning Service v. Statom, 710 S.E.2d 874, 877-78 (Ga. App. 2011) (reversible error to deny summary judgment where plaintiff submitted no expert evidence in carbon monoxide poisoning case); Allstate Insurance Co. v. Sutton, 658 S.E.2d 909, 915 (Ga. App. 2008) (summary judgment affirmed in toxic mold case where plaintiff had no expert medical testimony) (punctuation and footnotes omitted).

Product liability claims fall into the same category.

That [the product] can and did cause systemic disease in [plaintiff] is not a natural inference that a juror could make through human experience. Thus, medical expert testimony was essential to prove causation in this case.

Allison v. McGhan Medical Corp., 184 F.3d 1300, 1320 (11th Cir. 1999) (applying Georgia law).  See Thurmond v. Bayer Healthcare Pharmaceuticals, Inc., 649 F. Appx. 1003, 1006, n.1 (11th Cir. 2016) (“medical expert testimony is essential in products liability actions when the theory of causation is not a natural inference that a juror could make through human experience”) (applying Georgia law); Wilson v. Taser International, Inc., 303 F. Appx. 708, 715 (11th Cir. 2008) (applying Georgia law) (“[i]n product liability cases, proof of causation generally requires reliable expert testimony”); O’Shea v. Zimmer Biomet Holdings, 342 F. Supp.3d 1354, 1364 (N.D. Ga. 2018) (design defect plaintiff “must produce evidence from an expert who . . . opine[s] that the risk inherent in the [product] design outweigh the utility or benefit derived from the product”); Roper v. Kawasaki Heavy Industries, Ltd., 2015 WL 11236553, at *20 (N.D. Ga. June 29, 2015) (“expert testimony is necessary to prove causation if the causal connection between the defective product and the plaintiff’s injuries is not a natural inference that a juror could make through human experience”); Wheeler v. Novartis Pharmaceuticals Corp., 944 F. Supp.2d 1344, 1352 (S.D. Ga. 2013) (“In products liability cases, proof of causation generally requires reliable expert testimony.”); Brown v. Roche Laboratories, Inc., 2013 WL 2457950, at *8 (N.D. Ga. June 6, 2013) (“[e]xpert testimony is . . . essential to establish causation in this case”), aff’d, 567 F. Appx. 860 (11th Cir. 2014); Parker v. Brush Wellman, Inc., 2010 WL 3730924, at *8 (N.D. Ga. Sept. 17, 2010) (“Plaintiffs’ lack of expert testimony is fatal to the causation element of their failure to warn claim”), aff’d, 445 F. Appx. 231 (11th Cir. 2011); Jack v. Glaxo Wellcome, Inc., 239 F. Supp.2d 1308, 1321 (N.D. Ga. 2002) (entering summary judgment after plaintiffs’ experts excluded in prescription medical product case); Wheat v. Sofamor, S.N.C., 46 F. Supp.2d 1351, 1361-62 (N.D. Ga. 1999) (same); Smith v. Ortho Pharmaceutical Corp., 770 F. Supp. 1561, 1565 (N.D. Ga. 1991) (“Scientific testimony by expert witnesses on the issue of causation plays an increasingly vital role in [Georgia] products liability litigation.”).


Expert testimony in Hawai’i is required where “lay jurors are ill prepared to evaluate complicated technical data for the purpose of determining . . . whether there is a causal relationship between the violation of a duty and an injury to the patient.”  Exotics Hawaii-Kona, Inc. v. E.I. Du Pont De Nemours & Co., 172 P.3d 1021, 1044 (Haw. 2007) (quoting Bernard v. Char, 903 P.2d 676, 682 (Haw. App.), aff’d, 903 P.2d 667 (Haw. 1995)).  In medical causation cases, “[e]xpert medical testimony . . . was required to establish this essential element [causation] of the plaintiff’s case.”  Devine v. Queen’s Medical Center, 574 P.2d 1352, 1353 (Haw. 1978).  Where a plaintiff “sustained a ‘sophisticated injury,’ . . . a reasonable jury would need expert medical testimony to determine whether and to what extent any alleged negligence by Defendants contributed to his” injuries.  Barbee v. Queen’s Medical Center, 194 P.3d 1098, 1123 (Haw. App. 2008).

Thus, “the plaintiff is generally required to provide expert testimony to establish an element of their negligence case.”  Baker v. Gaspar, 2019 WL 984271, at *6 (D. Haw. Feb. 28, 2019).  “[B]ecause Plaintiffs-Appellants’ symptoms were medically complex, and . . . beyond the familiarity of the ordinary juror, the jury would have been incompetent to determine the issue of causation.  Consequently, expert testimony was essential to enabling the jury to determine causation.”  Kim-Alaniz v. Executive Center AOAO, 2013 WL 1943181, at *4 (Haw. App. May 10, 2013).

The same is true of product liability.  See Haake v. Safeway, 819 F. Supp.2d 1132, 1137 (D. Haw. 2011) (“These are not facts that are subject to common knowledge − Plaintiff needs medical evidence to substantiate these allegations.”); Windward Aviation, Inc. v. Rolls-Royce Corp., 2011 WL 2670180, at *21 (D. Haw. July 6, 2011) (“res ipsa loquitur is inapplicable to the complex technical causation issues in this case, for which Plaintiffs have offered no expert testimony in opposition”).


Expert opinion is mandatory in Idaho litigation where “the causative factors are not ordinarily within the knowledge or experience of laymen composing the jury.”  Easterling v. Kendall, 367 P.3d 1214, 1226 (Idaho 2016).  “[M]atters [that] are scientific or far removed from the usual and ordinary experience of the average person . . . require expert knowledge.”  Kolln v. Saint Luke’s Regional Medical Center, 940 P.2d 1142, 1149 (Idaho 1997).  “[A] lay person cannot arrive at a decision as to causation without the benefit of an expert.”  Id. at 1228.

[W]here the subject matter regarding the cause of disease, injury, or death of a person is wholly scientific or so far removed from the usual and ordinary experience of the average person that expert knowledge is essential to the formation of an intelligent opinion, only an expert can competently give opinion evidence as to the cause of death, disease or physical condition.

Holdaway v. Broulim’s Supermarket, 349 P.3d 1197, 1203 (2015) (citation and quotation marks omitted).  A “permanent . . . condition as it exists months or years after the [incident] requires expert testimony to establish causation.”  Dodge-Farrar v. American Cleaning Services Co., 54 P.3d 954, 959 (Idaho App. 2002).

Thus, “[w]hether or not the [drug] taken by [plaintiff] was a cause of his [condition] is a matter of science that is far removed from the usual and ordinary experience of the average person.”  Swallow v. Emergency Medicine of Idaho, P.A., 67 P.3d 68, 77 (Idaho 2003).  Similarly,“in a toxic tort case . . . the issue of causation is framed by the expert opinions of scientists and treating physicians.”  Earl v. Cryovac, 772 P.2d 725, 728 (Idaho App. 1989).  See McGiboney v. CCA Western Properties, Inc., 2016 WL 843253, at *8 (D. Idaho March 1, 2016) (“complex questions of medical causation require expert testimony”); Sabo v. Fiskars Brands, Inc., 2014 WL 4365319, at *16 (D. Idaho Sept. 2, 2014) (“If the complexity of the causation issue is beyond common experience, expert testimony is required to establish causation.”) (citation and quotation marks omitted).


Illinois law holds:

Without question, the human body is complex.  In most cases, the connection between the parts of the body and past and current injuries is a subject that is beyond the ken of the average layperson.  Because of this complexity, we do not believe that, in normal circumstances, a lay juror can effectively or accurately assess the relationship between a prior injury and a current injury without expert assistance.

Peach v. McGovern, ___ N.E.3d ___, 2019 WL 324608, at *5 (Ill. Jan. 25, 2019) (quoting Voykin v. Estate of DeBoer, 733 N.E.2d 1275, 1280 (Ill. 2000)).  Thus, “a plaintiff in a personal injury case must present the testimony of a medical expert to establish causation if the relationship between the claimed injury and the event in question requires special knowledge and training to establish.”  Brown v. Baker, 672 N.E.2d 69, 71 (Ill. App. 1996).  “[L]ay views about the origins of these medically complex problems do not suffice.”  Joyce v. J.C. Penney Corp., 389 F. Appx. 529, 531 (7th Cir. 2010) (applying Illinois law).

Numerous Illinois decisions have followed this rule in product liability and toxic tort cases.

[P]roduct liability cases are analogous to those involving medical malpractice:  Both types of cases involve specialized knowledge that bear directly on the standard of care in the community. . . .  [E]xpert opinion usually is required to aid the jury in determining that the pertinent standard of care has been breached.

Baltus v. Weaver Division, 557 N.E.2d 580, 589 (Ill. App. 1990).  See Clark v. River Metals Recycling, LLC, 929 F.3d 434, 441 (7th Cir. 2019) (“under Illinois law, [plaintiff] needed expert testimony to pin down exactly why the machine was designed in a defective way”) (applying Illinois law); Show v. Ford Motor Co., 659 F.3d 584, 585 (7th Cir. 2011) (“expert testimony is vital in design-defect suits when aspects of a product’s design or operation are outside the scope of lay knowledge”) (applying Illinois law); Korte v. Exxonmobil Coal USA, Inc., 164 F. Appx. 553, 556 (7th Cir. 2006) (“Expert testimony is needed to establish causation in cases alleging an adverse health effect when the medical effects of exposure to the toxin are not within the ken of the ordinary person.”) (applying Illinois law);  Fuesting v. Zimmer, Inc., 421 F.3d 528, 537 (7th Cir. 2005) (“In the absence of such [expert] evidence, [plaintiff] cannot establish the requisite elements of his claim.”), vacated in part on other grounds, 448 F.3d 936 (7th Cir. 2006) (remedy) (applying Illinois law); Wintz v. Northrop Corp., 110 F.3d 508, 515 (7th Cir. 1997) (“Under Illinois law, to serve as [evidence of] the proximate cause of the plaintiff’s injury, an expert must be able to testify with a reasonable degree of medical certainty that proximate cause existed.”) (applying Illinois law); Henry v. Panasonic Factory Automation Co., 917 N.E.2d 1086, 1091 (Ill. App. 2009) (“plaintiffs cannot establish a breach of the standard of care in this case without expert testimony”); Kane v. Motorola, Inc., 779 N.E.2d 302, 310 (Ill. App. 2002) (“plaintiffs . . . must come forward with scientific evidence regarding causation to preclude the entry of summary judgment”); Northern Trust Co. v. Upjohn Co., 572 N.E.2d 1030, 1036 (Ill. App. 1991) (“expert testimony shall be necessary . . . in a case, such as the one at bar, where a drug manufacturer’s liability for a prescription drug is based upon its failure to provide adequate warnings”); In re Depakote, 2017 WL 5483607, at *2 (S.D. Ill. Nov. 15, 2017) (“Expert testimony is necessary to establish proximate causation in cases where a drug manufacturer has failed to provide adequate warnings.”); In re Trasylol Products Liability Litigation, 2010 WL 8354662, at *18 (S.D. Fla. Nov. 23, 2010) (“Under Illinois law, where special medical knowledge is required, Plaintiff must present expert medical testimony to establish causation.”) (applying Illinois law); Lewis v. PDV America, Inc., 532 F. Supp.2d 1006, 1010-11 (N. D. Ill 2008) (lack of expert causation testimony fatal to plaintiff’s case and warrants summary judgment); Wroble v. Lockformer Co., 2006 WL 695254, at *1 (N.D. Ill. March 17, 2006) (“a plaintiff must establish proximate cause in a personal injury action through the admissible testimony of an expert witness”); Muller v. Synthes Corp., 2002 WL 460827, at *6 (N.D. Ill. March 26, 2002) (issue of “the design parameters of a medical implant . . . is one that goes beyond the knowledge that the average lay person reasonably could be expected to possess.  Accordingly, competent proof on this issue requires expert testimony.”).


Under Indiana law, “expert testimony is required where the question involves medical factors beyond the common knowledge of the layman.”  Willis v. Westerfield, 839 N.E.2d 1179, 1188 (Ind. 2006).  “Indiana law makes clear that “questions of medical causation of a particular injury are questions of science necessarily dependent on the testimony of physicians and surgeons learned in such matters.”  Higgins v. Koch Development Corp., 794 F.3d 697, 703 (7th Cir. 2015) (quoting Armstrong v. Cerestar USA, Inc., 775 N.E.2d 360, 366 (Ind. App. 2002)) (applying Indiana law).

[W]hen there is no obvious origin to an injury and it has multiple potential etiologies, expert testimony is necessary to establish causation. . . .  Without an expert, a plaintiff in such a complex case would be free . . . to prove his allegations relying on the logical fallacy “post hoc ergo propter hoc”. . . .  [W]e conclude that a causation expert is required in this case.

Id., 794 F.3d at 703 (citations and quotation marks omitted).

Thus, where “the question of the causal connection . . . is a complicated medical question . . ., testimony of an expert witness on the issue is necessary.”  Daub v. Daub, 629 N.E.2d 873, 877 (Ind. App. 1994).  See Timm v. Goodyear Dunlop Tires North America, Ltd., ___ F.3d ___,  2019 WL 3559049, at *3 (7th Cir. Aug. 6, 2019) (“Indiana law required expert testimony here because distinguishing expected from enhanced injuries was an inquiry beyond the understanding of lay jurors”) (applying Indiana law); C.W. v. Textron, Inc., 807 F.3d 827, 838 (7th Cir. 2015) (“With no experts to prove causation − be it general or specific − the appellants cannot prove their toxic-tort case under Indiana law.”) (applying Indiana law); Piltch v. Ford Motor Co., 778 F.3d 628, 634 (7th Cir. 2015) (plaintiffs “cannot establish the existence of a defect without expert testimony”) (applying Indiana law); Ervin v. Johnson & Johnson, Inc., 492 F.3d 901, 905 (7th Cir. 2007) (“In the absence of any other expert evidence supporting [plaintiff’s] causation theory, the district court properly granted summary judgment.”).  See Armstrong v. Cerestar USA, Inc., 775 N.E.2d 360, 366 (Ind. App. 2002) (“questions of medical causation of a particular injury are questions of science necessarily dependent on the testimony of physicians and surgeons learned in such matters”) (quoting Hannan v. Pest Control Services, 734 N.E.2d 674, 679 (Ind. App. 2000)).

The same is true in prescription medical product cases.  “[W]hen the issue involves the complex internal medicine question of what caused a person’s symptoms when a drug is involved, that is a matter requiring expert opinion to connect the dots.”  Allen v. Hook-SupeRx, LLC, 2015 WL 1757086, at *3 (N.D. Ind. April 17, 2015).

Under Indiana law questions of medical causation of a particular injury are questions of science necessarily dependent on the testimony of physicians and surgeons learned in such matters.  When there is no obvious origin to an injury and it has multiple potential etiologies, expert testimony is necessary to establish causation.

Robinson v. Davol, Inc., 913 F.3d 690, 695 (7th Cir. 2019) (citations and quotation marks omitted) (applying Indiana law).

A mere temporal relationship between [Plaintiff’s] ingestion of [a drug] and his subsequent injury cannot form the basis for a reasonable finding of causation. . . .  Any finding of the fact of causation based solely on facts within the understanding of lay jurors would be bald speculation.  Therefore, this matter presents a situation where expert testimony is not only helpful but absolutely necessary.  When the issue of proximate cause is not within the understanding of lay persons, testimony of an expert witness on the issue is necessary. Questions of medical causation of a particular injury are questions of science necessarily dependent on the testimony of physicians and surgeons learned in such matters.

Porter v. Whitehall Laboratory, Inc., 791 F. Supp. 1335, 1341-42 (S.D. Ind. 1992) (citations and quotation marks omitted), aff’d, 9 F.3d 607, 612 (7th Cir. 1993) (“[w]e agree with the district court that expert testimony is necessary”).  See Dalton v. Teva North America, 891 F.3d 687, 692 (7th Cir. 2018) (“the issue of causation in [plaintiff’s] case is not obvious . . . therefore . . . [plaintiff] could not prove her tort claims without expert testimony”) (applying Indiana law); Bowersock v. Davol, Inc., 236 F. Supp.3d 1074, 1089 (S.D. Ind. 2017) (summary judgment granted on causation in medical device case after all plaintiff’s experts excluded), aff’d, 913 F.3d 690 (7th Cir. 2019); Tucker v. SmithKline Beecham Corp., 701 F. Supp.2d 1040, 1047 (S.D. Ind. 2010) (“Causation is a required element of each of the plaintiff’s claims, and, in pharmaceutical cases, expert testimony is required to prove a causal connection between the drug and its alleged effects.”); Minisan v. Danek Medical, Inc., 79 F. Supp.2d 970, 975 (N.D. Ind. 1999) (“[p]roof of legal causation in a medical device case must be by expert testimony”).


Iowa law establishes that “medical causation . . . is essentially within the domain of expert testimony.”  Dunlavey v. Economy Fire & Casualty Co., 526 N.W.2d 845, 853 (Iowa 1995).  “[H]ighly technical questions of diagnoses and causation which lie beyond the understanding of a layperson require introduction of expert testimony.”  Donovan v. State, 445 N.W.2d 763, 766 (Iowa 1989).  “[M]edical testimony regarding whether an accident caused an injury is not within the knowledge and experience of ordinary layperson.”  Yates v. Iowa West Racing Ass’n, 721 N.W.2d 762, 774 (Iowa 2006).  “[U]nder Iowa law, due to its complex and scientific nature, medical causation almost always requires expert testimony.”  Vanderberg v. Petco Animal Supplies Stores, Inc., 906 F.3d 698, 707 (8th Cir. 2018)  (citation and quotation marks omitted) (applying Iowa law).  “[I]n toxic tort cases, ‘expert medical and toxicological testimony is unquestionably required to assist the jury’ in determining general and specific causation.”  Kinseth v. Weil-McLain, 913 N.W.2d 55, 69 (Iowa 2018) (quoting Ranes v. Adams Laboratories, Inc., 778 N.W.2d 677, 688 (Iowa 2010)).

The same rule applies in product liability litigation.  “In proving both types [general and specific] of causation, expert medical and toxicological testimony is unquestionably required to assist the jury.”  Junk v. Terminix International Co., 628 F.3d 439, 450 (8th Cir. 2010) (following Ranes) (applying Iowa law).  “In cases involving complicated technical and scientific issues expert testimony is required to submit the issue of a product defect under Iowa law.”  Iowa Great Lakes Sanitary District v. Travelers Casualty & Surety Co., 913 F.3d 760, 763 (8th Cir. 2019) (citation and quotation marks omitted) (applying Iowa law).  An “expert witness testimony opining that [the product] was a likely cause of [the injury is] a crucial element in products liability claims.”  Doe v. Baxter Healthcare Corp., 178 F. Supp.2d 1003, 1017 (S.D. Iowa 2001), aff’d, 380 F.3d 399 (8th Cir. 2004).  “Any decision which pertains to the design of the [medical] device involves engineering, metallurgical and medical principles beyond common knowledge and experience.”  Benedict v. Zimmer, Inc., 405 F. Supp.2d 1026, 1033 (N.D. Iowa 2005).  Questions concerning alternative designs “cannot be fully understood by the average juror without some expert assistance.”  Id. (citation omitted).  Similarly, “to show the device was defective because of inadequate instructions or warnings requires expert testimony.”  Id.  Likewise:

the element of causation . . . requires the presentation of expert evidence.  The court concludes the [plaintiffs] must present some expert testimony to prove the complex medical device caused [the] injuries. Causation in this case is a complex medical issue that is beyond common knowledge and experience.

Id. at 1033-34 (citations omitted).  See James v. Swiss Valley AG Service, 449 N.W.2d 886, 890 (Iowa App. 1989) (“when technical issues are involved (issues beyond common knowledge and experience) in a products liability or a products-related case, expert testimony is required to generate a jury issue”) (citation omitted); Rock v. Smith, 985 F. Supp.2d 1066, 1072 (S.D. Iowa 2013) (“Establishing liability for failure to instruct or warn also requires a plaintiff to establish that the lack of instructions or warnings caused the plaintiff harm.”) (citation omitted); Neilson v. Whirlpool Corp., 2012 WL 13018693, at *9 (S.D. Iowa Jan. 3, 2012) (“this products liability action contains issues that are beyond the understanding of the average juror and, therefore, expert testimony is required”); Korte v. Mead Johnson & Co., 824 F. Supp.2d 877, 887 (S.D. Iowa 2010) (“Plaintiffs must use the testimony of medical experts to prove medical causation”); Cummings v. Deere & Co., 589 F. Supp.2d 1108, 1118 (S.D. Iowa 2008) (“the present action involves complicated technical and scientific issues such that expert testimony is required to submit the issue of a product defect to a jury under Iowa law”) (footnote omitted); Housley v. Orteck International, Inc., 488 F. Supp.2d 819, 829 (S.D. Iowa 2007) (“The design, manufacture, use, and installation of [the product] is a matter largely outside the experiences of the average juror,” therefore “expert testimony is required”).


“[T]he well-established test” in Kansas “for determining whether expert testimony is required is whether the subject matter is too complex to fall within the common knowledge of the jury and is beyond the capability of a lay person to decide.”  Williamson v. Amrani, 152 P.3d 60, 72 (Kan. 2007) (superseded by statute on other grounds). “Expert testimony is necessary where normal experience and qualifications of lay persons serving as jurors does not permit them to draw proper conclusions from the facts and circumstances of the case.”  Pope v. Ransdell, 833 P.2d 965, 973 (Kan. 1992).  Accord Hare v. Wendler, 949 P.2d 1141, 1148 (Kan. 1997) (quoted in Williamson).

The expert requirement has been repeatedly applied in Kansas product liability cases.  See Ralston v. Smith & Nephew Richards, Inc., 275 F.3d 965, 974 (10th Cir. 2001) (“[w]ithout the expert testimony . . ., we can discern no material issue of fact with regard to the adequacy of the warnings provided by [the medical device manufacturer]”) (applying Kansas law); Robison Farms, Inc. v. ADM Alliance Nutrition, Inc., 2007 WL 2875132, at *19 (D. Kan. Sept. 29, 2007) (where “the facts involve such technical complexities that they exceed the experience and understanding of the average layman . . . without the aid of expert testimony, a reasonable trier of fact could not determine the cause of the harm”) (citation, footnote, and quotation marks omitted); Vanderwerf v. SmithKlineBeecham Corp., 529 F. Supp.2d 1294, 1306 (D. Kan. 2008) (“plaintiffs cannot meet their burden of proving medical causation without expert testimony that [the drug] can cause [plaintiff’s injury]”); Miller v. Pfizer, Inc., 196 F. Supp.2d 1095, 1125 (D. Kan. 2002) (“Because plaintiffs have no scientific evidence of general causation, their claim of failure to warn must fail as a matter of law.”), aff’d, 356 F.3d 1326 (10th Cir. 2004); Smith v. Pfizer Inc., 2001 WL 968369, at *12 (D. Kan. Aug. 14, 2001) (“plaintiff cannot establish general causation, inadequate testing, or inadequate warning because she has no expert through whom to present evidence that a causal relationship or an association exists”).


In Kentucky courtrooms, “[i]t is an accepted principle that in most medical negligence cases, proof of causation requires the testimony of an expert witness because the nature of the inquiry is such that jurors are not competent to draw their own conclusions from the evidence without the aid of such expert testimony.”  Baylis v. Lourdes Hospital, Inc., 805 S.W.2d 122, 124 (Ky. 1991) (citations and footnote omitted).  “[T]he human body is perhaps the most complex system known to humankind, so . . . this is exactly why our legal system requires reliable expert proof on issues such as medical causation.”  Kingery v. Sumitomo Electric Wiring, 481 S.W.3d 492, 499 (Ky. 2015).  Thus, “[e]xperts are often required in complex cases in which a jury will not understand, through common knowledge or experience, the intricacies involved in the negligence claim.”  Caniff v. CSX Transportation, Inc., 438 S.W.3d 368, 374 (Ky. 2014).

Likewise, “expert testimony is required in a products liability case . . . when the subject presented is so distinctly related to an area that is so far removed from the grasp of the average lay person.”  Stevens v. Keller Ladders, 1 F. Appx. 452, 458 (6th Cir. 2001) (applying Kentucky law).

As a general rule, expert witnesses are generally necessary, indeed essential, in products liability cases, as they are in medical malpractice actions, to prove such matters as a product defect and proximate causation, unless of course the nature of the defect and resultant injuries are so obvious as to fall within the general knowledge of the ordinary person.

Thomas v. Manchester Tank & Equipment Corp., 2005 WL 3673118, at *1 (W.D. Ky. May 13, 2005) (citation and quotation marks omitted).

[E]xpert testimony is necessary to support the element of causation in a negligence action when the common knowledge or experience of lay persons cannot recognize or infer a causal connection between the alleged negligence and the injury.  Courts have held that personal injury cases arising out of exposure to drugs involve complex questions of medical causation beyond the understanding of a lay person, and these require expert testimony on causation issues.

Hans v. Matrixx Initiatives, Inc., 2007 WL 2668594, at *3 (W.D. Ky. Sept. 6, 2007) (citations omitted).  See Hill v. Express Tan, Inc., 2019 WL 1757534, at *3 (W.D. Ky. April 19, 2019) (“Without expert testimony on any defect related to the tanning bed, the jury would be left to speculate.”) (citation and quotation marks omitted); Sturgeon v. Johnson & Johnson, 2017 WL 4080686, at *2 (E.D. Ky. Sept. 14, 2017) (summary judgment appropriate against expert-less plaintiff because “[t]he nature of any defect in the [medical device] is not something that falls within the general knowledge of ordinary people”); Wells v. Wal-Mart Stores Inc., 2016 WL 1453912, at *1 (E.D. Ky. April 13, 2016) (“Expert witnesses are ‘generally necessary’ in a Kentucky products liability case to prove the presence of a defect.”); Earle v. United States, 2016 WL 8814363, at *6 (Mag. E.D. Ky. Feb. 8, 2016) (“Laypeople certainly are not competent, based on common, everyday experience, to judge relative injury causation or delay effect as to a highly complex area of the body.”), adopted, 2016 WL 1417811, at *5 (E.D. Ky. April 11, 2016); Hinken v. Sears Roebuck & Co., 2015 WL 165027, at *4 (E.D. Ky. Jan. 13, 2015) (following Thomas and Watson; granting summary judgment); Trent v. Ford Motor Co., 2 F. Supp.3d 1022, 1027 (W.D. Ky. 2014) (plaintiff’s “design defect claim turns on specialized knowledge that cannot be determined intelligently from testimony on the basis of ordinary knowledge gained in the ordinary affairs of life.”) (citation and quotation marks omitted); Fimbres v. Garlock Equipment Co., 2014 WL 2612513, at *8 (W.D. Ky. June 11, 2014) (“Without the benefit of expert testimony on this issue, Plaintiff cannot meet her burden of producing evidence of the inadequacy of [defendant’s] warnings.”); Burgett v. Troy-Bilt LLC, 970 F. Supp.2d 676, 683 (E.D. Ky. 2013) (plaintiffs’ “attempt to establish causation would crumble for another reason: they need an expert witness”), aff’d, 579 F. Appx. 372 (6th Cir. 2014); Adams v. Cooper Industries, Inc., 2012 WL 2339741, at *1 (E.D. Ky. June 19, 2012) (“Both elements of causation require scientific assessments that must be established through expert testimony.”); Jeffrey v. Taylor, 2012 WL 694030, at *5 (W.D. Ky. March 1, 2012) (“the complicated nature of the issues of medical causation and damages require expert testimony and not merely Plaintiff’s lay opinion”); Dailey v. Hoffman/New Yorker, Inc., 2011 WL 5598908, at *3 (E.D. Ky. Nov. 17, 2011) (the product “is a technical piece of equipment and expert testimony is required not only to explain the various possible explanations for the accident, including any design and manufacturing defects, but also to opine about the probable cause of the accident”); Freytes v. Wal-Mart Stores East, LP, 2011 WL 2119383, at *4 (E.D. Ky. May 26, 2011) (“expert testimony establishing a connection between the [product] and [plaintiff’s] injuries is likely necessary”; plaintiff “simply asks the jury to speculate and surmise too much”); May v. Ford Motor Co., 2010 WL 5391605, at *2 (E.D. Ky. Dec. 22, 2010) (following Thomas; granting summary judgment); Watson v. Ford Motor Co., 2009 WL 5064316, *3 (E.D .Ky. Dec. 15, 2009) (“Expert witnesses are generally necessary, indeed essential, in products liability cases, as they are in medical malpractice actions, to prove such matters as a product defect and proximate causation.”); Snyder v. American Honda Motor Co., 2009 WL 2342733, at *7 (E.D. Ky. July 28, 2009) (“Kentucky law requires Plaintiffs to present expert testimony demonstrating that Defendants’ product was defective because the subject matter falls outside the general knowledge of the ordinary person”); Honaker v. Innova, Inc., 2007 WL 1217744, at *2 (W.D. Ky. April 23, 2007) (“Expert testimony is almost always needed to meet the plaintiff’s burden in a products liability case.”).


For once, Louisiana law is not peculiar, holding that “only a physician or other qualified expert is capable of judging what [medical] risk exists and the likelihood of occurrence.”  Snider v. Louisiana Medical Mutual Insurance Co., 130 So.3d 922, 930 (La. 2013).

[W]e find the plaintiff was required to produce evidence from a medical expert to establish a breach of the standard of care, as well as causation. . . .  Here, the plaintiff was required to present medical evidence to establish the defendant’s actions fell below the standard of care and caused her injuries.  Without this evidence, the plaintiff has, in our view, failed to show that she will be able to carry her burden of proof at trial. . . .  We conclude the plaintiff . . . was required to produce expert medical evidence sufficient to establish that she will be able to satisfy her evidentiary burden of proof at trial.

Schultz v. Guoth, 57 So.3d 1002, 1009-10 (La. 2011) (citations omitted).  “[O]ur long standing jurisprudence has held, because of the complex medical and factual issues involved, a plaintiff will likely fail to sustain his burden of proving his claim . . . without medical experts.”  Khammash v. Clark, 145 So.3d 246, 259 (La. 2014) (citations and quotation marks omitted).  See Madere v. Collins, 241 So.3d 1143, 1149 (La. App. 2018) (“complex surgical and medical actions . . . require expert evidence of the applicable standard of care and expert testimony regarding negligence and causation”).

The same is true in product liability and toxic tort actions. (“When a conclusion regarding medical causation is not one within common knowledge, expert medical testimony is required in a tort action.”  Johnson v. E.I. DuPont de Nemours & Co., 7 So.3d 734, 740 (La. App. 2009).  “[T]o conclude that a different [design] or a different warning would have” changed the outcome in a product liability action,

therefore raises questions that are of sufficient complexity to be beyond the expertise of the average judge and juror and that common sense does not make obvious.  Accordingly, [plaintiffs] were required to provide the jury with expert testimony related to causation.

Stewart v. Capital Safety USA, 867 F.3d 517, 521-22 (5th Cir. 2017) (applying Louisiana law).  See Boudreaux v. Bollinger Shipyard, 197 So.3d 761, 775 (La. App. 2016) (“expert medical testimony is required when the conclusion regarding medical causation is one that is not within common knowledge”); Bourgeois v. Garrard Chevrolet, Inc., 811 So.2d 962, 967 (La. App. 2002) (“Without expert testimony, the plaintiff cannot carry his burden of proof that the [product] was defective in design or that an alternative design would have prevented the plaintiff’s injuries”); Hutchinson v. Shah, 648 So.2d 451, 452 (La. App. 1994) (“When the conclusion regarding medical causation is not one within common knowledge, expert medical testimony is required.”); Winstead v. Georgia Gulf Corp., 77 F. Appx. 267, 271 (5th Cir. 2003) (plaintiff “was required to present expert testimony because the cause of [a] chemical release is beyond the understanding of an untrained lay person”) (applying Louisiana law); Barber v. Spinal Elements, 2019 WL 3554200, at *4 (E.D. La. Aug. 5, 2019) (“courts consistently require expert testimony in products liability cases, when the product or feature in question is complex, and a layman may not readily grasp the implications”); Talbot v. Electric Insurance Co., 2018 WL 6274314, at *3 (M.D. La. Nov. 30, 2018) (“as a matter of law, non-expert testimony by a fact witness is insufficient to establish medical causation”); Patton v. Boston Scientific Corp., 2018 WL 4760846, at *2 (W.D. La. Oct. 2, 2018) (“in tort actions involving complex medical devices and concepts, medical causation cannot be established without the aid of expert medical testimony”); Williams v. Janssen Pharmaceuticals, 2016 WL 6127526, at *2 (W.D. La. Oct. 20, 2016) (“A plaintiff must have expert medical testimony to prove causation in a product liability claim involving prescription medications.”); Hooks v. Nationwide Housing Systems, LLC, 2016 WL 3667134, at *13 (E.D. La. July 11, 2016) (“In a toxic tort case, the plaintiff must present admissible expert testimony to establish general causation as well as specific causation. Konrick v. Exxon Mobil Corp., 2016 WL 430404, at *2 (E.D. La. Feb. 4, 2016) (“In a toxic tort suit, the plaintiff must present admissible expert testimony to establish general causation and specific causation”); Underwood v. General Motors LLC, 2015 WL 5475610, at *3 (M.D. La. Sept. 17, 2015) (“it is not possible for a jury to determine a product to be defective . . . without expert testimony”), aff’d, 642 F. Appx. 468 (5th Cir. 2016); Burst v. Shell Oil Co., 2014 WL 3893304, at *2 (E.D. La. Aug. 8, 2014) (“expert medical testimony is required to resolve the issue of general causation”); Demouchet v. General Nutrition Corp., 2014 WL 1652518, at *4 (W.D. La. April 24, 2014) (“In cases such as this, involving complex issues of medical causation that are beyond the realm of knowledge and experience of the ordinary juror, expert testimony must be presented by the plaintiff to prove specific causation.”); Sadler v. International Paper Co., 2014 WL 1217954, at *3 (W.D. La. March 24, 2014) (“A plaintiff in a toxic tort case must establish medical causation through expert testimony.”); Pratt v. Landings at Barksdale, 2013 WL 5376021, at *3 (W.D. La. Sept. 24, 2013) (“In a toxic tort suit, the plaintiff must present admissible expert testimony to establish general causation as well as specific causation.”) (citation and quotation marks omitted); Rhodes v. Bayer Healthcare Pharmaceuticals, Inc., 2013 WL 1282450, at *2 (W.D. La. March 28, 2013) (“lack of an expert to establish causation is fatal to Plaintiffs’ claims”); Autery v. SmithKline Beecham Corp., 2011 WL 1812793, at *6 (Mag. W.D. La. April 12, 2011) (“courts routinely dismiss product liability cases in which expert testimony on causation is lacking”), adopted, 2011 WL 1828343 (W.D. La. May 12, 2011), aff’d, 496 F. Appx. 388 (5th Cir. 2012); Horton v. Wyeth Pharmaceuticals, 2010 WL 11607305, at *3 (W.D. La. May 27, 2010) (“summary judgment is appropriate on the independent ground that [plaintiffs] have failed to identify an expert witness or submit an expert report.  Such failure is fatal to their prescription drug product liability action, as expert medical testimony is required”); Smith v. Glaxosmithkline Corp., 2008 WL 4938426, at *2 (E.D. La. Nov. 17, 2008) (“Plaintiffs can only establish the required elements of causation between [the drug] and [decedent’s] death through expert testimony”); Waters v. Bayer Corp., 2006 WL 725820, at *2 (W.D. La. March 22, 2006) (“In a case such as this, involving complex medical issues not commonly known to the average person, the courts have held that expert medical testimony must be offered to prove causation.”); Kemp v. Metabolife International, Inc., 2004 WL 2095618, at *3 (E.D. La. Sept. 13, 2004) (“proof of actual causation requires medical testimony”).


Under Maine law, “[a]llowing a jury to infer causation on complex medical facts without the aid of expert testimony on the subject . . . stretches the jury’s role beyond its capacity.”  Merriam v. Wanger, 757 A.2d 778, 782 (Me. 2000).  Where a case “concerns such technical and involved medical procedure that it rules out any possibility of understanding on the part of a layman as to its medical nature” it falls within “the general rule [requiring] expert medical testimony.”  Cyr v. Giesen, 108 A.2d 316, 318 (Me. 1954).

[T]he identification of a cause for serious medical conditions . . . − let alone prospective injuries that have not yet developed − is neither a lay exercise” nor “a matter within common, non-expert understanding.  Rather, the causal relationship . . . draws on sophisticated science beyond the ken of the average juror.  Accordingly, a jury may not infer causation on complex medical facts without the aid of expert testimony.

Darney v. Dragon Products Co., LLC, 640 F. Supp.2d 117, 123 (D. Me. 2009) (citations, quotation marks, and footnote omitted).  See Samaan v. St. Joseph Hospital, 670 F.3d 21, 38 (1st. Cir. 2012) (“Given the complex medical question that underlies the issue of causation in this instance, expert testimony was essential.”) (applying Maine law); Rollins v. Wentworth, 2013 WL 3781504, at *7 (D. Me. 2013) (“with a plaintiff having as complex a medical history as [plaintiff], it would be necessary to produce expert testimony from a qualified medical expert”); Kalis v. Strang, 2005 WL 2715239, at *4 (Me. Super. May 9, 2005) (“because plaintiff never named an expert, he will be unable to link his symptoms to the [accident]”).


The rule in maritime cases is that “[e]xpert testimony is required whenever proof of an element of a claim, such as the duty of care or causation, calls for information that is outside an ordinary person’s common knowledge.”  Rhodes v. Energy Marine LLC, 2016 WL 6700973, at *3 (D. Ariz. Nov. 15, 2016) (applying maritime law).

Where, however, the nexus between the injury and the alleged cause would not be obvious to the lay juror, expert evidence is often required to establish the causal connection between the accident and some item of physical or mental injury.  In a case such as this, where an injury has multiple potential etiologies, expert testimony is necessary to establish causation, even in view of plaintiff’s reduced burden to prove causation.

Wills v. Amerada Hess Corp., 379 F.3d 32, 46 (2d Cir. 2004) (citations and quotation marks omitted) (Sotomayor, J.) (applying maritime law).  See Seaman v. Seacor Marine L.L.C., 326 F. Appx. 721, 729 (5th Cir. 2009) (in toxic exposure case, with expert testimony excluded, plaintiff “lacks competent summary judgment evidence that would create a genuine fact issue regarding . . . causation”) (applying maritime law); Gauthreaux v. United States, 694 F. Supp.2d 460, 465 (E.D. Va. 2009) (“in a products liability action, proof of causation must ordinarily be supported by expert testimony because of the complexity of the causation facts”) (applying maritime law); Holman v. Applied Drilling Technology, Inc., 2007 WL 1577660, at *3 (S.D. Tex. May 31, 2007) (“Expert testimony is particularly necessary in chemical-exposure cases, in which medically complex diseases and causal ambiguities compound the need for expert testimony.”) (citation and quotation marks omitted) (applying maritime law).

The Lawyers For Civil Justice is conducting a non-scientific poll on social media concerning challenges that litigators face that involve expert evidence.  LCJ’s poll asks the following question:

The Federal Rules of Evidence and Daubert require judges to determine whether the testimony offered by an expert witness is sufficiently reliable to be admitted.  To your knowledge, do federal judges consistently perform this gatekeeping responsibility?

We thought that blog readers might have something to say about that, so we talked to LCJ, and they agreed that we could offer these links to the poll to encourage our readers to participate:

While it’s not prescription medical product liability litigation, per se, we’ve been aghast, scratching our heads about the recent litigation firestorm surrounding the pesticide Roundup and its active ingredient, glyphosate.  Despite consistent findings from every regulatory body in the world – save one (the IARC) – that this product is not a carcinogen, plaintiffs peddling a bunch of junk science in California, the litigation junk science capital of the world, have been able to dupe jurors into concluding the opposite.  Between the consistent failure of lower courts to enforce the reliability standards imposed by the California Supreme Court in Sargon Enterprises, Inc. v. University of Southern California, 288 P.3d 1237 (Cal. 2012), and the Ninth Circuit’s dumbing down of Daubert in Wendell v. GlaxoSmithKline, LLC, 858 F.3d 1227 (9th Cir. 2017) (our 9th worst decision of 2017), jurors in Roundup cases have been exposed to mountains of pseudo-scientific garbage masquerading as “totality of the evidence,” with absurd results.

And then the State of California itself pops out of the clown car, asserting that its notorious Proposition 65 (the same one that recently sought to call coffee a carcinogen) requires a cancer warning on glyphosate.

Well, finally there’s an adult in the room.  The Environmental Protection Agency, which has jurisdiction over product labeling for Roundup/glyphosate has taken steps to enforce its prior no-carcinogen finding.  In a formal letter dated August 7, 2019, has rejected any carcinogen labeling:

Given EPA’s determination that glyphosate is “not likely to be carcinogenic to humans,” EPA considers the Proposition 65 language based on the chemical glyphosate to constitute a false and misleading statement.  As such, pesticide products bearing the Proposition 65 warning statement due to the presence of glyphosate are misbranded pursuant to section 2(q)(1)(A) of FIFRA. . . .  The warning statement must be removed from all product labels. . . .

EPA “Dear Registrant” letter, at 1-2.  EPA thus “disagrees with the IARC’s assessment of glyphosate,” id. at 1, and in the United States, the EPA has the requisite legal authority to govern product labeling.

Further, given the EPA’s action, all the civil litigation should be preempted under the Supreme Court’s recent decision in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019).  Albrecht deals with implied preemption, so its holdings apply equally to other regulatory regimes besides the FDCA – just as, in the other direction, the “genuinely equivalent” standard for parallel claims originating in FIFRA, see Bates v. Dow Agrosciences LLC, 544 U.S. 431, 454 (2005), has applied to FDCA-regulated products.  See Bexis’ book §5.02[4][d] footnote 320 (collecting cases).

Albrecht holds, with respect to agency rejections of labeling language:

  • “[T]he [agency] reviews [regulated] submissions and can reject label changes even after the manufacturer has made them.”  139 S. Ct. at 1679.
  • “[I]n the interim, [agency’s] regulation permits changes, so a [regulated] manufacturer will not ordinarily be able to show that there is an actual conflict between state and federal law.”  Id.
  • “[A]gency actions that can determine the answer to the pre-emption question, of course, are [those] taken pursuant to the [agency’s] congressionally delegated authority.”  Id.
  • “Federal law permits [a federal agency] to communicate its disapproval of a warning . . . by formally rejecting a warning label that would have been adequate under state law.”  Id. (citations omitted).
  • “[W]hatever the means the [agency] uses to exercise its authority, those means must lie within the scope of the authority Congress has lawfully delegated.”  Id.

It looks to us like the EPA’s letter, citing its statutory authority to reject a label as “misbranded” for being “false and misleading,” checks all of the Supreme Court’s boxes.  Further, the “interim” that the Court referred to with respect to the FDA’s CBE regulation in Albrecht doesn’t exist here – we have the EPA’s formal notification that “probably carcinogenic to humans” warnings are “misleading” in light of current science.

Thus, it seems blindingly clear that the EPA has “informed the [regulated entity] that the [agency] would not approve changing the [product’s] label to include that warning.”  Id. at 1678.  So, even assuming this is a case “like” Levine (which, given the prior regulatory proceedings, it probably isn’t) has the EPA been “fully informed . . . of the justifications for the warning required by state law”?  Id.  The EPA sure thinks so:

EPA scientists have performed an independent evaluation of the available data since the IARC classification to reexamine the carcinogenic potential of glyphosate and concluded that glyphosate is “not likely to be carcinogenic to humans.”  EPA considered a more extensive dataset than IARC, including studies submitted to support registration of glyphosate and studies identified by EPA in the open literature as part of a systematic review.

EPA letter at 1 (citing 2017 EPA “Issue Paper” on glyphosate and cancer).  We don’t think any state-law court can re-examine the scientific basis for a federal regulatory decision under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), but in this case we doubt it matters.

Thus, comparing the EPA’s position against the Albrecht template for implied preemption, we believe that preemption should be successful in stuffing the evil genie of glyphosate cancer litigation back into regulatory bottle where it belongs.

A couple of years ago, we were overjoyed to learn that our very favorite old-fashioned Broadway musical was being revived. The lead role – a famously brassy female character – was being played by a famously brassy singer and sometime-actress we believed was perfectly cast.   We bought tickets the day they went on sale, and we saw the show nearly as soon as it opened.   We could feel our excitement building at the swell of the first chords of the overture and at our first view of the Candy Land colors of the old-school set and costumes.   There was no place in the world we’d rather have been at that moment . . . and we were sorely disappointed. We thought the lead actress – notoriously bawdy and broad – played the role in much too “small” a fashion. The male lead was completely miscast. Inexplicable cuts had trimmed the best finale ever written to a mere footnote. And, once again, we were reminded that too-high expectation expectations beg to be dashed.

As they were in today’s case.  We really liked the first half of In re Biomet M2a Magnum Hip Implant Prods. Liab. Litig., 2017 WL 10845178 (N.D. Ind. Dec. 21. 2017), an older decision that inexplicably just appeared in our weekly search.  The judge in the metal-on-metal hip implant litigation was asked to decide Daubert motions filed by both sides.  He started with the plaintiffs’ motions to exclude five of the defendants’ experts.   First, the plaintiffs moved to exclude the opinions of the defendants’ mechanical engineering expert, a mechanical engineer and professor of tribology (the science of friction, wear, and lubrication – who knew??) related to the “reasonableness” of the defendant’s “design and safety decision-making,” Biomet, 2017 WL 10845178 at *2.   The court denied the motion, explaining that the expert’s opinions were based on his review of “a large design file,” which met “Rule 702’s threshold requirement that an opinion be based on sufficient facts or data.” Id. at *3. The defendant argued that the expert’s “reasonableness” opinions were based on his review of “relevant literature, depositions, and [the defendant’s] design files for the devices at issue in this case.” Id. at *3. The court held that the files the expert reviewed met “Rule 702’s threshold requirement that an opinion be based on sufficient facts or data,” id. at *4, and that questions about other documents he could have considered were appropriately left for cross-examination.

Second, the judge considered the plaintiffs’ motion to exclude two categories of opinions of the defendant’s biomaterials expert. The judge held that the expert was not qualified to offer “sweeping” opinions about regulatory compliance but that he could offer opinions about the defendants’ compliance with regulatory requirements to the extent that such compliance played a role in the development of the devices at issue. The judge denied the motion to exclude the expert’s general opinions about factors surgeons consider in selecting a hip implant device.

Third, the plaintiffs moved to exclude the testimony of the defendant’s regulatory expert on issues related to the 510(k) clearance process. The plaintiffs argued that: 1) they did not contend that the defendant violated the 510(k) process and regulatory compliance was a question of law an expert could not resolve; 2) the expert’s opinion that the 510(k) process considers safety and effectiveness in addition to “substantial compliance: was contrary to FDA statutory and regulatory authority; and 3) evidence of 510(k) clearance was more prejudicial than probative.   Id. at *5. The court explained the split of authority on the admission of testimony about 510(k) clearance, then held that it would be premature for the court to rule on the admissibility of the expert’s testimony on a litigation-wide basis at the MDL level.   Instead, the court held, resolution of the motion fell into the category of state-law determinations that should be made on remand to transferor courts.

Fourth, the Plaintiffs moved to exclude the testimony of the defendant’s orthopedic surgeon/joint replacement specialist. The defendant offered the expert to testify about, “among other things, the rationale for second generation metal-on-metal devices.” Id. at *8. The plaintiffs moved to exclude the expert’s opinions on tribology, offering that he was unqualified to offer them. The court explained that the expert’s opinions on “allegedly improved tribological characteristics of the second-generation metal-on-metal implants” were admissible to the extent that “they [were] the type on which an orthopedic surgeon would commonly rely.” Id.   But, the court emphasized, the expert couldn’t “take the place of a tribology expert and offer opinions beyond those on which an orthopedic surgeon would commonly rely.” Id. As such, the court granted the motion to the extent that the expert was attempting to testify as a tribology expert and denied it to the extent that an orthopedic surgeon would reasonably rely on the opinions.

Finally, the defendant offered a biomedical engineer to testify about its testing of the hip implant device. The plaintiffs sought to exclude the expert’s conclusion that: 1) the defendant’s postmarket surveillance and use of the information it obtained were appropriate; and 2) the defendant “reviewed information in peer-reviewed journals concerning clinical experience with [its] devices and appropriately applied any new knowledge that was acquired” in assessing the products’ long-term safety and efficacy.   Id. at *9. The plaintiffs argued that the expert lacked the specialized training or experience that would qualify him to offer these opinions, including training or experience with FDA regulatory procedures, that the expert did not employ a sound methodology, and that the defendant did not need an expert to testify to the fact of post-market surveillance. The court disagreed, noting that the expert’s field was hip device wear testing and holding that his qualifications in analyzing data form those tests qualified him to analyze data from post-market testing and reports. The court rejected the “unreliable methodology” argument, holding that the expert’s opinions were admissible because they were “reasoned, use[d] the methods of [his] discipline, and [were] founded on data.”   Id.   The court excluded a single opinion offered by the expert – the opinion that metal-on-metal revision rates might be artificially high because of heightened scrutiny of the devices, finding that the theory was not supported by any of Daubert’s indicia of scientific reliability – the theory was not tested, peer-reviewed, evaluated for error rates, or accepted within the scientific community.

The Defendant’s Motions to Exclude the Plaintiff’s Experts

By this point in the decision, we hoped that the judge’s denial of the vast majority of the plaintiffs’ motions signaled a pro-defense approach that would translate into exclusion of the plaintiffs’ experts. By and large, this was not to be.

The court first considered the defendant’s motion to exclude the plaintiffs’ biomedical engineering expert, who offered the opinions that: 1) the defendant’s products were defective; 2) metal-on-polyethylene implants were a safer, feasible alternative design; 3) the defendant’s testing of its devices was inadequate; 4) the defendant’s warnings were inadequate; 5) the defendant downplayed the risks of the devices; and 6) excessive metal ions produced by metal-on-metal devices cause clinical effects in patients.   The defendant moved to exclude all of the opinions.

First, the defendant argued that the expert was not qualified to offer the opinion that all metal-on-metal devices are defectively designed. The court denied the motion, holding that the expert’s experience as an engineer qualified her to opine on the design issues even though her degrees were in mechanical engineering and not tribology. Next, the court held that the expert could testify to her proposed “alternative design,” and that omissions in the information she considered were appropriately reserved for cross-examination. The court found that the expert was qualified to opine about the adequacy of the defendant’s testing, notwithstanding her lack of training in tribology, and that she employed a reliable methodology in formulating those opinions when she “examined the testing [the defendant] conducted and pointed to other testing employed in peer-reviewed studies.”

With respect to the expert’s “inadequate warnings” opinions, the court held that the expert’s experience “developing and reviewing warnings for orthopedic products” qualified her to offer the opinions, notwithstanding the fact that she was not an orthopedic surgeon and had no medical training. The court also held that the expert employed a reliable methodology when she “compared [the defendant’s] warnings with relevant research on the alleged risks associated with metal-on-metal devices and opined on what additional warnings were necessary based on the deficiencies she found,” even though she did not “explain whether and how additional warnings would have affected a surgeon’s decisions” and did not “test her theories through studies or other mechanisms.” Id. at *13.

Finally, the court held that the expert could not testify “as an expert on the clinical effects of metal ions” but could “permissibly rely on other experts’ opinions that metal ions cause clinical effects to support her opinion that metal-on-metal devices [were] unreasonably dangerous.” Id. at *15.

The plaintiffs’ second expert was an orthopedic surgeon specializing in joint replacement. Like the first expert, he offered opinions that the defendant’s devices, and metal-on-metal devices generally, were defectively designed and that the defendant’s testing and instructions for use were inadequate.

The defendant argued that the expert was not qualified to offer his design opinions because he had no training in tribology. The court rejected this argument, explaining, “While [the expert] discusses issues that arguably fall within the field of tribology, . . . Rule 703 allows an orthopedic surgeon to reasonably rely on the opinions of other experts.” Id. at *16. The court held that the expert permissibly relied on the expertise of others when his opinions required knowledge outside of his own field of expertise, and that that he employed reliable methodology in arriving at his general opinions about metal-on-metal devices. The court did exclude the expert’s specific opinions about the design of the defendant’s devices, holding that he had not considered sufficient device-specific data in developing these opinions. The court also excluded the expert’s opinion that the defendant’s testing of its devices was inadequate because he had not conducted a sufficient review of the relevant testing data.   But the expert was permitted to testify about the adequacy of the defendant’s instructions for use because he “compared the facts in evidence with the content shown” in the instructions for use.   Id. at *18.

So while the judge excluded an opinion here and there, he admitted most of the plaintiffs’ experts’ opinions.  Call us biased, but we thought that the judge’s analysis of the defendant’s experts’ opinions was mostly quite strong but that he stretched too far in allowing the plaintiffs’ experts to testify far outside of their fields of expertise and to offer opinions that were the products of questionable methodologies.  No great surprise there.  But hope springs eternal, and we will continue to watch for the “good” while we report on the “bad” and the “ugly.”

We have always thought that regulatory approval or clearance of a drug or medical device should weigh heavily against punitive damages, or even preclude punitive damages altogether.  An Arizona statute says exactly that, and now a trial court in Phoenix has applied that statute to dismiss punitive damages in a case involving a medical device cleared through the 510k Premarket Notification process.  This is a significant ruling because the majority of implanted medical devices reach the market under section 510k rather than the more extensive Premarket Approval process.

The case is McMahill v. C.R. Bard, Inc., No. CV 2017-000927, slip op. (Ariz. Super. Ct. July 23, 2019), and while the order is a mixed bag overall, the holding on punitive damages is very helpful.  The plaintiff was treated with the defendant manufacturer’s inferior vena cava filter and experienced filter fracture, which is a known and warned-of risk for all venous filtration devices.  Slip op. at 2.  The defendant’s motion for summary judgment was only partly successful.  The court declined to find that the filter was “unavoidably unsafe” as a matter of law under comment k to section 402A of the Restatement (Second) of Torts and denied summary judgment on the design defect claim.  Id. at 2-3.

The court also denied summary judgment on the failure-to-warn claim, even though it was undisputed that the implanting physician did not read the device’s instructions for use.  Id. at 4-5.  On the warnings claim, the court just missed the point.  The court reasoned that it was disputed whether the physician would have used the defendant’s device had he received additional information about filter fracture.  But it would not have made a difference had the defendant provided additional information in the instructions for use because the physician did not read them.  That is a failure of warnings causation.  It seems as though the court lost sight of the fact that the plaintiff bears the burden of proof.

The express warranty claim went by the boards because there was no evidence that the plaintiff received any representations about the filter before it was implanted and also for lack of privity.  Id. at 5-6.

The order’s highlight is the grant of summary judgment on punitive damages.  Arizona law provides that a manufacturer or seller of a product is not liable for exemplary or punitive damages if:

The product alleged to have caused the harm was designed, manufactured, packaged, labeled, sold or represented in relevant and material respects according to the terms of an approval, conditional approval, clearance, license or similar determination of a government agency.

Ariz. Rev. Stat. § 12-689 (emphasis added).  This is pretty broad protection, and it expressly includes the term “clearance.”  That takes care of the main argument that plaintiffs level in cases involving devices “cleared” under the 510k process, rather than “approved” under the Premarket Approval process.  That overblown distinction has had an outsized impact ever since the Supreme Court’s outdated opinion in Medtronic v. Lohr, 518 U.S. 470 (1996), including with regard to federal preemption and more lately in connection with the admissibility of evidence of the section 510k regulatory pathway.

The Arizona statute does not provide any leeway:  “Here, undisputed evidence shows that the [defendant’s] filter received clearance from the FDA.  As a result, the statute bars plaintiff claim for punitive damages.”  McMahill, at 6.

The plaintiff tried three attacks on the statute, none of them successful.  First, the plaintiff argued that the statute was enacted after the plaintiff’s filter was implanted.  But that was not true, and the plaintiff’s right of action did not vest until he filed his lawsuit in any event.  Id.

Second, the plaintiff argued that the statute violated multiple provisions of the Arizona Constitution.  But one of the cited constitutional provisions applied only to the right “to recover damages for injuries,” and punitive damages are not awarded to compensate for injuries.  Id.  They are awarded “to punish the wrongdoer and deter others.”  Id.  The statute is also not an impermissible “special law,” nor does it unconstitutionally grant protection to a certain class of defendants.  This last point appears to address equal protection under the laws, as the court couched its ruling in terms of the legislature’s basis for enacting the law:  “Here, the legislature has made a determination intended to encourage the development of medical devices in Arizona.”  Id.

Finally, the plaintiff argued that the statute did not apply because the manufacturer “knowingly violated a material and relevant reporting requirement.”  Id at 7.  This sounds to us like a “fraud on the FDA” claim that is preempted under Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001).  But the court did not even need to get to preemption because the Arizona statute expressly addresses this situation:  Withholding information from the government or violating reporting requirements avoid Arizona’s statutory protection against punitive damages only if the government has found a violation.  Id.  There was no evidence that the FDA ever “found” that “material information related to the [defendant’s] filter was knowingly unreported.”  Id.

Many thanks to the attorneys at Nelson Mullins who brought this order to our attention.

Offhand, we cannot think of opinions we have blogged on that pleased us more than today’s cases, Jacob v. Mentor Worldwide, LLC, et al., 2019 WL 3500325 (C.D. Cal. Aug. 1, 2019) and Vieira v. Mentor Worldwide, LLC, et al., 2019 WL 3500331 (Aug. 1, 2019). The two decisions are virtually identical and come out the right way on issues important to drug and device defendants, such as snap removals, fraudulent joinder, and preemption. The decisions are well-reasoned, well-organized, and well-written All of that is encouraging and important. But the additional fact that delights us is that the author of the opinions is Judge Andre Birotte.

We have been an admirer of Andre Birotte for almost a quarter of a century. We were in the United States Attorney’s Office in Los Angeles back in 1995, when Birotte came on board. He had formerly served as a deputy public defender, so he brought a useful perspective to the task. Right from the start, Birotte was a superstar AUSA. He was brilliant, hard-working, and had a marvelous sense of humor. It was evident that he was destined for higher things. It did not take long. Birotte was appointed by President Obama as the United States Attorney. Later, he became a federal judge. His accomplishments are impressive. Birotte was born to Haitian immigrants in Newark , New Jersey, not far from where we grew up. The last time we saw Birotte was at a dinner in honor of an AUSA colleague who died of ALS. It was an evening filled with stories, tears, and laughter. Not to put too fine a point on it, we think the world of Birotte. So, in addition to our defense-hackiness, please take into account our veneration of the Judge as we take a look at the Jacob and Vieira opinions.


The Jacob and Vieira cases were both filed in California state court on behalf of multiple plaintiffs alleging injuries from ruptured silicone breast implants. The plaintiffs sued multiple defendants, including the manufacturer, the raw material supplier, and a holding company. The holding company, like some of the plaintiffs, was a citizen of California. The causes of action included negligence, failure to warn, and manufacturing defect. The defendants removed the case to federal court and then moved to dismiss the complaints for failure to state a claim. The plaintiffs moved to remand the cases to state court.


The Jacob case involved a snap removal (that is, prior to service) by one of the defendants. As usual, the plaintiff resisted a literal interpretation of 28 U.S.C. section 1441(b)(2), which provides that a civil action “may not be removed if any of the parties in interest properly joined and served as defendants is a citizen of the State in which such action is brought.” The Jacob case had been removed before any California defendant had been served, so the forum defendant rule of section 1441(b)(2) did not warrant remand. To be sure, there is some C.D. Cal. authority that waters down the availability of snap removals if there are “absurd or bizarre results.” For example, in one prior case the defendants filed a notice of removal on diversity grounds before the Superior Court made the summons available to the plaintiff. In that case, it was impossible for the plaintiff to serve the defendants before removal. But nothing like that unusual situation existed in Jacob. It had not been impossible for the plaintiff in Jacob to serve the defendants. Thus, the Jacob court followed C.D. Cal. precedent, followed the plain text of section 1441(b)(2), and refused to remand the case on the basis of the forum defendant rule. (You can find our magnum opus on pre-service removal here.)

That did not end the subject of subject matter jurisdiction. In both the Jacob and Vieira cases, the court could not retain federal jurisdiction without deciding whether the California holding company had been fraudulently joined. If the holding company was legitimately in the case, there was no diversity jurisdiction, at least not with the California plaintiffs. (The court decided that the various plaintiffs had been properly joined. That is the one part of these decisions we do not adore.) Most of you reading this blog know that it is not easy for defendants to show fraudulent joinder. Nevertheless, demonstrating fraudulent joinder did turn out to be pretty easy in Jacob and Vieira. In a product liability action, the plaintiff must establish that the defendant produced, manufactured, sold, or was in some way responsible for the allegedly defective product. (Is that “some way responsible for” the basis for innovator liability in The Golden State? Grrrr. Do not get us started.) The holding company did not produce, manufacturer, or sell. It merely … held. And it what it held was investments, not silicone breast implants. The holding company was not a proper defendant in these lawsuits. It was dismissed, and the cases stayed in front of an article III federal judge – and a very good one, at that.


The breast implants were class III medical devices that went through the rigorous pre-market approval (PMA) process. As such, they are covered by the express preemption provisions of the Medical Device Amendments (MDA). The plaintiffs, predictably, invoked the specious presumption against preemption. But Judge Birotte had read the SCOTUS Puerto Rico v. Franklin Cal. Tax-Free Trust case, and correctly ruled that there is no presumption against express preemption. The plain language of the MDA preempts state requirements that are “different from, or in addition to,” federal requirements. One does not need a presumption to interpret that statement of Congressional intent; one needs only literacy. The plaintiff desperately argued that it was “difficult to believe that Congress would remove all means of judicial recourse for consumers injured by FDA approved devices.” Judge Birotte’s riposte was definitive: “Contrary to Plaintiffs’ position, ‘this is exactly what a pre-emption cause for medical devices does by its terms.” (quoting Riegel). (We presumed to hold forth against the presumption against preemption here.)

Judge Birotte also ruled that the plaintiffs had not managed to thread the needle and state the dreaded parallel claim purportedly authorized by Riegel. As with many other circuits, the Ninth Circuit has recognized that there is a “narrow gap” through which a state-law claim must fit to escape preemption. The plaintiff must be suing for conduct that violates the federal Food, Drug, and Cosmetic Act (or else the claim would be preempted) but the plaintiff must not be suing because the conduct violates the FDCA (or else it would be preempted by Buckman). The plaintiffs in Jacob and Vieira claimed that the defendants violated federal and state law by failing to report adverse events to the FDA, but they cited no specific adverse events. The plaintiffs also claimed poor performance on post approval studies – but that results in a big so what. That is no violation of law. Finally, the plaintiffs claimed defective manufacturing that contravened federal regulations and state law, but the never identified the precise standards. In sum, the parallel violations were based on mere incantations, not allegations

    Failure to Report

Cases from and within the Ninth Circuit suggest that the failure to warn claim’s only hope for survival depended on a showing that if the defendants had properly reported adverse events to the FDA as required under federal law, that information would have reached the plaintiffs’ doctors and thereby prevented the plaintiffs’ injuries. Mind you, we think the theory is hogwash and should be preempted, but it doesn’t much matter in the Jacob and Vieira cases, because the plaintiffs’ allegations could not pass muster. The plaintiffs “have not explained how any purported failure to report the unspecified adverse events caused [their] injuries.” Moreover, the plaintiffs did not “allege facts showing that the FDA would have exercised its discretion to include additional adverse events in its publicly-accessible adverse- event database.” Nor did they allege that any of “their treating physicians even relied on information in the adverse event database making decisions.”

    Manufacturing Defect

Manufacturing defect claims are usually stinkers and that proved to be the case in Jacob and Vieira. The plaintiffs alleged that the implants “differed in some undefined way from the manufacturing and design specifications mandated by the FDA as part of the PMA.” The plaintiffs merely alleged that the defendants violated unspecified “laws and regulations” or produced a “nonconforming” device. Such bloviations do not adequately establish violation of a federal requirement. They also do not establish that the alleged violations actually caused the alleged injuries. As Judge Birotte concluded, “[m]ore is needed.”

Because the plaintiffs did not supply the more that was needed, and because it was clear that such “more” was not forthcoming, Judge Birotte dismissed the plaintiffs’ claims with prejudice, “[a]s amendment would be futile.”


We knew when we were in the U.S. Attorney’s Office in the mid-90s that we were surrounded by a remarkable group of men and women. When we read opinions such as Judge Birotte’s, or learn of Dan Collins’s ascendancy to the Ninth Circuit, or see Representative Schiff on the cable news at night, or are treated to accounts in Law360 of former colleagues triumphing in front of juries and appellate panels, we count ourselves singularly blessed to have worked alongside such superb lawyers.

Bexis attended the recent Rolling Stones concert in Philadelphia – the first time he’d seen them live since 1975.  The highlights:  while they’re really old (Jagger just turned 76), they still rock.  Whoever supplied Mick Jagger’s heart valve implant should pay whatever it takes to get a public endorsement.  Defying expectations, Keith Richards is still alive.  Charlie Watts looks like a retired accountant rather than a rock drummer.  The biggest highlight, though, is of course the music.  Here’s a link to the Philadelphia setlist.  The Stones playlist so exceeds any other still-touring group, that they could stage a concert matching the Who, Billy Joel or Fleetwood Mac (Bexis knows) and still not play a single song from the Philadelphia setlist.

Speaking of highlights, in 2006 the FDA overhauled drug labeling and created a new section called “highlights.”  See 21 C.F.R. §201.57(a) (specifying highlights section requirements).  For one thing the highlights must include “[a] concise summary of any boxed warning.”  §201.57(a)(4).  With respect to all other warnings, contraindications, and adverse reactions, the highlights regulation provides:

(9) Contraindications.  A concise statement of each of the product’s contraindications, as required under paragraph (c)(5) of this section, with any appropriate subheadings.

(10) Warnings and precautions.  A concise summary of the most clinically significant information required under paragraph (c)(6) of this section, with any appropriate subheadings, including information that would affect decisions about whether to prescribe a drug, recommendations for patient monitoring that are critical to safe use of the drug, and measures that can be taken to prevent or mitigate harm.

(11) Adverse reactions.

(i) A list of the most frequently occurring adverse reactions, as described in paragraph (c)(7) of this section, along with the criteria used to determine inclusion (e.g., incidence rate).  Adverse reactions important for other reasons . . . must not be repeated under this heading in Highlights if they are included elsewhere in Highlights. . . .

21 C.F.R. §201.57(a)(9-11) (emphasis added).

As the Stones might say, “It’s all right now, in fact, it’s a gas. . . .”

The FDA’s final rule adopting the regulation described the “highlights” section:

[T]he final rule requires that the labeling for new and more recently approved products include introductory information entitled “Highlights of Prescribing Information” (Highlights) (§§201.56(d)(1) and 201.57(a)).

The final rule requires the same headings for Highlights as proposed, except that, in response to comments, FDA moved “Most Common Adverse Reactions” from “Warnings and Precautions” (proposed §201.57(a)(10)) to a new heading entitled “Adverse Reactions” (§§201.56(d)(1) and 201.57(a)(11)).  Like the proposed rule, the final rule requires that Highlights, except for the boxed warning, be limited in length to one-half of the page (§ 201.57(d)(8)) (see comment 104).

The agency is also revising its regulations on supplements and other changes to an approved application in §§314.70 and 601.12 (21 CFR 314.70 and 601.12) to require applicants to obtain prior approval of any labeling changes to Highlights, except for identified minor changes (see comment 5).

“Requirements on Content & Format of Labeling for Human Prescription Drug and Biological Products, 71 Fed. Reg. 3299, 3925 (FDA Jan. 24, 2006) (emphasis added).

“Things are different today. . . .”

Now for preemption.  The Supreme Court just reaffirmed that limits to the preemption of labeling claims for prescription drugs are grounded in the availability of FDA’s changes being effected (“CBE”) regulation, which defeats implied impossibility preemption by allowing certain unilateral label modifications:

[A]n FDA regulation called the “changes being effected” or “CBE” regulation permits drug manufacturers to change a label without prior FDA approval if the change is designed to “add or strengthen a . . . warning” where there is “newly acquired information” about the “evidence of a causal association” between the drug and a risk of harm.  21 C.F.R. §314.70(c)(6)(iii)(A).

Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1673 (2019).

[F]ederal law − the FDA’s CBE regulation − permits drug manufacturers to change a label to “reflect newly acquired information” if the changes “add or strengthen a . . . warning” for which there is “evidence of a causal association,” without prior approval from the FDA. 21 C.F.R. §314.70(c)(6)(iii)(A).  Of course, the FDA . . . can reject label changes even after the manufacturer has made them. See §§ 314.70(c)(6), (7). . . .  But in the interim, the CBE regulation permits changes, so a drug manufacturer will not ordinarily be able to show that there is an actual conflict between state and federal law such that it was impossible to comply with both.

Id. at 1679.

“War, children, is just a shot away. . . .”

This CBE regulation relied on in Albrecht − 21 C.F.R. §314.70 − is precisely the same regulation that the FDA stated it was “revising” in 2006 “to require applicants to obtain prior approval of any labeling changes to Highlights.”  71 Fed. Reg. at 3925 (listing “§314.70”).  The CBE regulation thus has excepted all aspects of the “highlights” section from its scope since 2006.

(6) The agency may designate a category of changes for the purpose of providing that, in the case of a change in such category, the holder of an approved NDA may commence distribution of the drug product involved upon receipt by the agency of a supplement for the change. These changes include. . . .

(iii) Changes in the labeling to reflect newly acquired information, except for changes to the information required in §201.57(a) of this chapter (which must be made under paragraph (b)(2)(v)(C) of this section), to accomplish any of the following:

(A) To add or strengthen a contraindication, warning, precaution, or adverse reaction for which the evidence of a causal association satisfies the standard for inclusion in the labeling under §201.57(c) of this chapter. . . .

21 C.F.R. §314.70(c)(6)(iii)(A) (emphasis added).  This is the Albrecht FDA CBE regulation – right down to the last subsection.

“This could be the last time. . . .”

The FDA imposed this limitation on changes to “highlights” information deliberately – through notice and comment rulemaking.  See Albrecht, 139 S. Ct. 1680 (endorsing the preemptive power of “notice-and-comment rulemaking setting forth labeling standards”).  Nor was this some nefarious scheme to benefit manufacturers.  To the contrary, as the FDA pointed out, “[m]anufacturers, with some exceptions, were opposed, or strongly opposed, to the inclusion of Highlights.”  71 Fed. Reg. at 3930.

In response to “comment 5,” the FDA stated, in 2006:

[B]ecause Highlights is a summary of the most important information for prescribing decisions and some comments expressed concerns about the difficulty involved in summarizing the complex and often lengthy information in the FPI, the agency believes that it is essential for FDA to review and approve most proposed changes to the information in Highlights.  Accordingly, the agency is revising its regulations on supplements and other changes to an approved application.  Under §§314.70(b)(2)(v)(C) and (c)(6)(iii) . . ., applicants are required to obtain prior approval of any labeling changes to Highlights, except for editorial or similar minor changes. . . .

71 Fed. Reg. at 3922 (emphasis added).  See Id. at 3922 (“a sponsor may not use a CBE supplement to make most changes to Highlights.”).

“No excuses offered anyway. . . .”

The Federal Register cross-reference for modifications of highlights, 21 C.F.R. §314.70(b)(2)(v)(C), is to “Changes requiring supplement submission and approval prior to distribution of the product made using the change (major changes).”  See also FDA, Guidance for Industry:  Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content & Format Requirements (Feb. 2013) (containing detailed information about how changes to “highlights” should be made).  Thus, any modification of the language of highlights is a “major change” – and tort actions demanding “major changes” are preempted.

Major changes require approval from the FDA prior to implementation, while moderate and minor changes do not.  Controlling case law is clear − and plaintiffs here concede − that if the change they contend state law requires qualifies as “major,” then federal law preempts plaintiffs’ cause of action because defendants cannot lawfully make such a change without prior FDA approval. Our inquiry thus appears, at first glance, straightforward:  Does the change urged by plaintiffs qualify as “major”?  If so, our work is done.

Gustavsen v. Alcon Laboratories, Inc., 903 F.3d 1, 10 (1st Cir. 2018) (citations omitted).  See Yates v. Ortho-McNeil Pharmaceuticals, Inc., 808 F.3d 281, 298 (6th Cir. 2015) (“[Plaintiff’s] post-approval design defect claim is clearly preempt-ed by federal law.  FDA regulations provide that once a drug . . ., is approved, the manufacturer is prohibited from making any major changes.”); Batoh v. McNeil-PPC, Inc., 167 F. Supp.3d 296, 320-22 (D. Conn. 2016) (“chang[ing] the active ingredient” would have been a “major change” requiring prior FDA approval).

“As heads is tails. . . .”

Preemption cases specifically involving demands to modify “highlights” have been uncommon, but have uniformly resulted in preemption.

In In re Zofran (Ondansetron) Products Liability Litigation, 368 F. Supp.3d 94, 127 (D. Mass. 2019), plaintiffs conceded preemption of any warning claim involving highlights.  The issue was fully litigated in Blackburn v. Shire US, Inc., 2017 WL 1833524, at *5-6 (N.D. Ala. May 8, 2017):

[W]hen sufficient newly acquired information exists in order to support a label change under the CBE process, as has been plausibly pled here, the claim is not preempted.  However, the same cannot be said with respect to Plaintiff’s assertion that a change to the Highlights section would be permitted here.  Where a private party seeks a label change which requires FDA approval, such as a change to the Highlights section, impossibility preemption exists. . . .  The “impossibility” inquiry turns on a private party’s ability to act independently.  It is of no consequence that the FDA may have allowed a change to the Highlights section of [the drug].  Because Defendants could not have independently changed the Highlights section of [the drug] in order to conform to state law, any argument that begins with the theory that Defendants could (or should) have changed the Highlights section of [the drug’s] label ends in preemption.

Id. at *5-6 (citations omitted).

Preemption can “take you places that you’ve never, never seen. . . .”

The same result was reached in Patton v. Forest Laboratories, LLC, 2018 WL 5270476 (C.D. Cal. May 10, 2018), with a Buckman wrinkle:

[Defendant] also argues that Plaintiffs’ failure-to-warn claim against it is preempted because: (1) [it] could not have “unilaterally or independently change[d] the Highlights section; all changes to that section require FDA’s pre-approval”. . . .

In their Opposition, Plaintiffs do not address [defendant’s] arguments concerning the permissible scope of label changes made by a NDA holder under the CBE process.  Instead, Plaintiffs argue that their failure-to-warn claim is not preempted because “Plaintiffs’ contentions are that the Defendants did not comply with their obligations under Federal law regarding the labeling of [the drug]. . . .’

While it is obvious that the FDA, in approving the relevant [drug’s] labeling, disagreed with Plaintiffs’ contention that the labeling violates “federal law” at the time it approved that labeling, even if the FDA were wrong, only the government (i.e., not Plaintiffs) may bring a lawsuit to enforce the FDCA and the FDA’s regulations.  Accordingly, Plaintiffs’ failure-to-warn claim, as presently constituted, is preempted.

Id. at *16-17 (citations omitted).  See Id. at *4 (“NDA holders may not make any changes to the Highlights section of a drug’s labeling without prior FDA approval”).  See also Patton v. Forest Laboratories, Inc., 2018 WL 5269239, at *11 (C.D. Cal. Sept. 19, 2018) (plaintiffs conceded preemption of claims affecting highlights).

“But it’s all over now. . . .”

“Highlights summarizes the information from the FPI [full prescribing information] that is most important for prescribing the drug safely and effectively.”  71 Fed. Reg. at 3922.  “[I]t is critical to ensure accuracy and consistency in the information included in Highlights because it contains a summary of the most important information for prescribing the drug safely and effectively.”  Id.  Thus, it would be impossible to maintain “Highlights [as] a concise extract of the most important information,” id., if plaintiffs could demand different or additional warnings in the full labeling that diverge from what is contained in unmodified, FDA-approved highlights.  So plaintiffs should not be able to evade preemption by ignoring “highlights” and demanding only changes to the rest of a drug’s labeling.  There’s an analogy here to the “sameness” that drives preemption in generic drug cases – for highlights to serve their intended function, they must convey the same information (in abbreviated form) as is found in the rest of a drug’s label.

“Now you’ve decided to show me the same. . . .”

Given preemption of warning claims involving all claims affecting “highlights”, defense counsel should consider, when deposing prescribers and treaters, inquiring into whether – assuming they consulted a given drug’s labeling at all – they read the entire package insert, or instead they only read the highlights.  Alternatively, a physician might only review portions of the full package insert based on material that s/he first saw in the highlights section.  Indeed, this is how the FDA anticipated that physicians would use highlights.  71 Fed. Reg. at 3930 (“because Highlights contains pointers to the location of more detailed information in the FPI, the pointers will increase the likelihood that health care practitioners will refer to the FPI”).  Favorable testimony along either of these lines would result in causation principles reinforcing the preemption arguments made above.

Preemption exists “when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency.”  PLIVA, Inc. v. Mensing, 564 U.S. 604, 623-34 (2011).  Thus, the preemptive effect of this “independence principle” extends to any product liability claim demanding a change to a black box warning, contraindication, warning, adverse event (or anything else, for that matter) that would require a corresponding modification to the drug’s highlights section.  As demonstrated above, the FDA’s current regulatory regime concerning highlights meets Albrecht’s requirement that “whatever the means the FDA uses to exercise its authority, those means must lie within the scope of the authority Congress has lawfully delegated.”  139 S. Ct. at 1679.

“I don’t give you a hoot of warning. . . .”

Simply stated, “to state a claim for failure-to-warn that is not preempted by the FDCA, a plaintiff must plead a labeling deficiency that Defendants could have corrected using the CBE regulation.”  Gibbons v. Bristol-Myers Squibb Co., 919 F.3d 699, 708 (2d Cir. 2019) (quoting Celexa, 779 F.3d at 41).  That regulation explicitly excludes any label change to the substance of the highlights section.  Potentially, that’s a lot of preemption, much more than suggested in Wyeth v. Levine, 555 U.S. 555 (2009) – which involved an older drug used in 2000, long before “highlights” existed.  Such older drugs are not subject to the “highlights” requirement at all.  21 C.F.R. §201.56(b) (new “labeling content and format requirements” apply only to post-2006 drugs).  But the amended CBE provision says what it says, and the Supreme Court has put that sort of objection to rest:

We acknowledge the unfortunate hand that federal drug regulation has dealt [these plaintiffs], and others similarly situated.  But it is not this Court’s task to decide whether the statutory scheme established by Congress is unusual or even bizarre. . . .  But different federal statutes and regulations may, as here, lead to different pre-emption results.  We will not distort the Supremacy Clause in order to create similar pre-emption across a dissimilar statutory scheme.  As always, Congress and the FDA retain the authority to change the law and regulations if they so desire.

Mensing, 564 U.S. at 625-26 (citation, quotation, and footnote marks omitted).

“If you try some time, you get what you need. . . .”

Get some Satisfaction – go forth and preempt.