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

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

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

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

  • First, the early bird discount for ACI ends September 27, making now a great time to register if you haven’t done so already as prices will increase.
  • Second, the good people at ACI asked the blog to be a media sponsor this year – and are offering a special registration discount for the conference for the blog’s readers. Make sure to use the code D10-710-710DX01 when you register. You’ll save 10 percent.

If you want to register, you can do so here. We look forward to seeing you in New York!

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

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

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

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

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

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

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

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

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

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

This appeared on September 3, 2019, on the Missouri Supreme Court’s list of “Writs and Other Original Proceedings”:

SC98009         State ex rel. Monsanto Company, Relator, vs. The Honorable Michael K. Mullen, Respondent.

Petition for writ of prohibition sustained.  Preliminary writ ordered to issue returnable to Court en banc within fifteen days.

(Emphasis original)

We understand, from inside sources, that this notation means that Monsanto has won its mandamus appeal from an order by St. Louis City Judge Mullen’s allowing a consolidated multi-plaintiff trial based on the now-discredited (see State ex rel. Johnson & Johnson v. Burlison, 567 S.W.3d 168 (Mo. 2019)) venue theory that the presence of any plaintiff residing in the city of St. Louis allows a trial there that includes multiple plaintiffs who do not live in St. Louis.  Given the notorious predilection that St. Louis City judges have shown towards such consolidated trials, this ruling could well impact a number of other cases and appeals.

There’s apparently no opinion yet, but this occurrence bears watching.

Last week, we found ourselves focusing on spoliation issues in two different cases, one at the front-end (an early case assessment) and one at the back-end (haggling over jury instructions). The Actos spoliation saga has made any sentient defendant antsy about these things. Thus, it is worthwhile to discuss Moore v. Abiomed, Inc., 20 U.S. Dist. LEXIS 147191 (C.D. Illinois Aug. 29, 2019), for its potentially helpful spoliation ruling, even if the rest of the opinion is forgettable.

The plaintiff had undergone open heart surgery, and the pump used during that surgery malfunctioned. The pump could not be removed at the end of the surgery, though it was designed to release and thereby facilitate such removal. Instead, a follow-up surgery was required for removal. The plaintiff alleged that the failed initial removal of the pump caused him to suffer from ischemia in extremities, resulting in the loss of three fingers in his dominant hand. The plaintiff filed claims against the pump manufacturer for strict product liability, res ipsa loquitur, negligence, breach of warranty, and spoliation. The spoliation claim was premised on the fact that the pump manufacturer sales representative present during the second operation did not retain the allegedly defective pump.

The defendant manufacturer moved to dismiss the strict liability claim based on a failure to specify the alleged defect. The court gave that argument the back of its hand. Failure of the release mechanism seems to be the claimed defect, and the egregious Bausch Seventh Circuit case stands as a formidable obstacle to insisting on much more detail. The defendant challenged the warranty claim for lack of privity, but the medical records showed that the plaintiff was charged over $60k for the pump, so he looked enough like a buyer. The defendant contended that the res ipsa claim was flawed because it was not in exclusive control of the pump – what about the hospital staff? – but the court concluded that the manufacturer had exclusive control when the pump was defectively manufactured, even if it did not during the surgery. All of those rulings could have gone the other way, but they didn’t, they are not totally shocking, they turn on factual peculiarities, and we don’t see them as precedents that will cause too much mischief going forward. (Unlike, say, the Bausch case, which is like a low-hanging beam in the basement that bangs us in the noggin every month or so.)

The spoliation claim lives or dies solely on the presence of a manufacturer’s sales representative at the explant surgery. But the representative never had possession of the pump, which was disposed of by one of the health care providers after it was removed. Illinois law controls the case, and Illinois imposes three requirements to support a claim of spoliation: (1) the defendant owes the plaintiff a duty to preserve the evidence, (2) the defendant breached that duty by losing or destroying the evidence, (3) the loss or destruction of the evidence prevented the plaintiff from proving up the lawsuit, and (4) the plaintiff suffered actual damages. Note that foreseeability of potential importance in later litigation isn’t, by itself, enough to support spoliation. There must be a special relationship, or, failing that, some sort of statutory duty or actual undertaking to create a duty to preserve evidence. Hence, even though the Moore court assumed that the plaintiff furnished enough facts to permit an inference that the sales rep should have foreseen that the pump might be material to a lawsuit, it held that the plaintiff still fell short of establishing potential spoliation:

“Missing from Plaintiff’s complaint, however, are any allegations of an agreement, contract, statute, special circumstances, or voluntary undertaking that gave rise to a duty to preserve evidence. Because Plaintiff has not alleged facts supporting both the relationship prong and the foreseeability prong, Plaintiff has failed to support a claim for spoliation.”

Moore, 2019 U.S. Dist. LEXIS 147191 AT *11.

We have written before about legal issues that arise when a company’s sales reps are present during surgeries. (It remains one of our more popular posts.). Spoliation is, obviously, one of those issues. The Moore case supplies some ammo for our clients to use when plaintiffs play the spoliation gambit.

Somebody asked Bexis the other day whether he thought that the increasing reliance on “telemedicine” – physician consultations taking place online, perhaps followed by the prescription of a drug or medical device – posed any risks to the learned intermediary rule.

Bexis said, “no.”  Would you expect other answer?

That response was based largely on gut reaction.  There is literally no caselaw.  The number of cases containing both “learned intermediary” and “telemedicine” is precisely zero.  Nor was substituting “telephone” any more illuminating.

This means that any legal analysis will have to be by analogy.  So, the first thing to do when analyzing this problem is to make sure exactly what we’re talking about.  Defining the term “telemedicine,” we mean legitimate consultations within an established physician-patient relationship.

What we don’t mean is some unknown, unnamed, “doctor” “prescribing” some drug through a fly-by-night Internet “pharmacy” after a 60-second consultation that never produces a medical record that makes it into the so-called “patient’s” files.  That’s illegal in the United States and, as for that category of patient, the most relevant legal principle is the in pari delicto rule, not the learned intermediary rule.  Yeah, people can cut corners that way to get drugs cheaper and maybe more easily, but they know it’s illegal, so if they are injured, it’s their own damn fault.

One place to look for a more formal definition of “telemedicine” is the Code of Federal Regulations.  For instance, to qualify for federal reimbursement by the Center for Medicare Services, providers of telemedicine:

must be composed of doctors of medicine or osteopathy.  In accordance with State law . . ., the medical staff may also include other categories of physicians . . . and non-physician practitioners who are determined to be eligible for appointment by the governing body.

(1) The medical staff must periodically conduct appraisals of its members.

(2) The medical staff must examine the credentials of all eligible candidates for medical staff membership and make recommendations to the governing body on the appointment of these candidates in accordance with State law. . . .  A candidate who has been recommended by the medical staff and who has been appointed by the governing body is subject to all medical staff bylaws, rules, and regulations, in addition to the requirements contained in this section.

(3) When telemedicine services are furnished . . ., the governing body of the hospital whose patients are receiving the telemedicine services may choose, in lieu of the requirements in paragraphs (a)(1) and (a)(2) of this section, to have its medical staff rely upon the credentialing and privileging decisions made by the [provider] . . . [so long as] all of the following provisions are met:

(i) The [provider] providing the telemedicine services is a Medicare-participating hospital.

(ii) The individual distant-site physician or practitioner is privileged at the [provider], which provides a current list of the distant-site physician’s or practitioner’s privileges. . . .

(iii) The individual distant-site physician or practitioner holds a license issued or recognized by the State in which the . . . patients are receiving the telemedicine services is located.

(iv) . . . [A]n internal review of the distant-site physician’s or practitioner’s performance of these privileges . . . [including] all adverse events that result from the telemedicine services provided by the distant-site physician or practitioner to the hospital’s patients and all complaints the hospital has received about the distant-site physician or practitioner.

42 C.F.R. §482.22(a)(3).  See also 42 C.F.R. §§482.12 and 485.616.

There are also a bunch of state laws specifying that “telemedicine” is more than a brief phone call or internet survey.  A statute in Massachusetts, for  instance, defines “telemedicine” as the “use of interactive audio, video or other electronic media for the purpose of diagnosis, consultation or treatment” but excludes “audio-only telephone, facsimile machines or email.”  Mass. Gen. Laws ch. 175, §47BB(a).  Other state telemedicine definitional statutes or regulations are:  Cal. Bus. & Prof. Code §2290.5(g)(3); Colo. Rev. Stat. §12-36-102.5(8); Ga. Code §33-24-56.4(b)(3); Haw. Rev. Stat. §453-1.(b); Ky. Rev. Stat. §205.510(15); La. Rev. Stat. §37:1262(4); Me. Rev. Stat. tit. 24-A, §4316(1); Md. Code, Health §19-319(e)(I)(ii); Mich. Comp. Laws §500.3476(2); N.H. Rev. Stat. §415-J:2(II); N.M. Stat. §13-7-14(H)(6); Okla. Stat. tit. 36, §6802; Or. Rev. Stat. §442.015(25); Tex. Gov. Code §531.001(8); Vt. Stat. tit. 8, §4100k(g)(4); Va. Code §38.2-3418.16(B)

Finally, the American Telemedicine Association describes “telehealth” on its website:

Services Provided by Telehealth

Sometimes tele is best understood in terms of the services provided and the mechanisms used to provide those services.  Here are some examples:

Live videoconferencing (synchronous) – the delivery of a live, interactive consultation between Primary care and specialist health services.  This may involve a primary care or allied health professional providing a consultation with a patient, or a specialist assisting the primary care physician in rendering a diagnosis.

Store and forward (asynchronous) – the use of store and forward transmission of diagnostic images, vital signs and/or video clips along with patient data for later review that enables a primary care or allied health professional providing a consultation the ability to render a diagnosis.

Remote patient monitoring (RPM) – including home telehealth, uses devices to remotely collect and send data to a home health agency or a remote diagnostic testing facility (RDTF) for interpretation.  Such applications might include a specific vital sign, such as blood glucose or heart ECG or a variety of indicators for homebound consumers. Such services can be used to supplement the use of visiting nurses.

Mobile health (mHealth) – Consumer medical and health information includes the use of the internet and wireless devices for consumers to obtain specialized health information and online discussion groups to provide peer-to-peer support.

For any formal definition of “telemedicine,” the requirement of real consultations within a true physician-patient relationship is pretty clear.  Thus, so is the analogy to existing learned intermediary rule.  Actually, this kind of debate has happened before – back in the 1960s and 1970s when governmental units across the country sponsored “mass vaccinations.”  Those vaccines were prescription medical products and like all such products, had inherent risks.  That led to a line of cases that created the “mass vaccination” exception to the learned intermediary rule, the only exception formally enshrined in Restatement (Third) of Torts, Products Liability §6(c).

The mass vaccination cases are collected in Bexis’ book §2.03[3][b].  This exception is applicable:

Where there is no physician to make an individualized balancing of the risks . . ., the very justification for the [learned intermediary rule] evaporates.  Thus, as in the case of patent drugs sold over the counter without prescription, the manufacturer of a prescription drug who knows or has reason to know that it will not be dispensed as such a drug must provide the consumer with adequate information.

Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1276 (5th Cir. 1974) (applying Texas law).  If the dispensing of a prescription medical product happens between an “anonymous member of the public and an equally anonymous dispenser of the medicine,” the learned intermediary rule loses its justification.  Stanback v. Parke, Davis & Co., 657 F.2d 642, 647 (4th Cir. 1981) (applying Virginia law).  See Samuels v. American Cyanamid Co., 495 N.Y.S.2d 1006, 1013 (N.Y. Sup. 1985) (learned intermediary rule inapplicable to vaccines dispensed through a company clinic “without any meaningful appraisal by an ‘informed intermediary’”).

However, attempts to extend what is really a “no real prescriber” exception beyond its rather limited set of facts have failed.  This “exception to the informed intermediary doctrine will apply only if an in-depth analysis of the benefits and risks to the individual of the [drug’s] administration appears to be unlikely.”  Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281, 292 (6th Cir. 2015) (quoting Samuels) (applying New York law).  The oral contraceptives in Yates were not prescribed is such an informal fashion:

[Plaintiff] was counseled meaningfully by her prescribing medical provider, such that no exception to the informed intermediary doctrine applies here. . . .  [The clinic physician] adequately counseled [plaintiff’s] regarding her different birth control options.  [the physician] was aware of several personal matters that affected [plaintiff’s] birth control selection. . . .  [The clinic] is not a clinic designed to quickly process patients; rather, [the physician] testified that it is her custom to use her independent medical judgment when prescribing birth control products to patients, and she specifically testified that she discussed the risks and benefits of several different forms of birth control with [plaintiff].

Id. at 293.  See DiBartolo v. Abbott Laboratories, 914 F. Supp.2d 601, 614 (S.D.N.Y. 2012) (“This is not a case when the manufacturer knows or has reason to know that health-care providers will not be in a position to reduce the risks of harm in accordance with the instructions or warnings”; the prescriber “met with [plaintiff] individually prior to prescribing her [the drug]”).

Several other cases have likewise held the exception inapplicable where a doctor is in position to exercise independent medical judgment.  See Hexum v. Eli Lilly & Co., 2015 WL 4943959, at *8 (C.D. Cal. Aug. 18, 2015) (“This is not a case where a drug was dispensed en masse without any individualized assessment by a physician); In re Zyprexa Products Liability Litigation, 2010 WL 4052913, at *4 (E.D.N.Y. Oct. 12, 2010) (“no basis for” exception where the prescriber “considered [plaintiff’s] specific symptoms and condition and made an individualized determination that treatment with [the drug] was appropriate”) (applying North Carolina law); Porter v. Eli Lilly & Co., 2008 WL 544739, at *8 (N.D. Ga. Feb. 25, 2008) (exception “inapplicable to the instant case where [plaintiff] met individually with [the prescriber] who considered [plaintiff’s] history and then decided to prescribe [the drug]”), aff’d mem., 291 F. Appx. 963 (11th Cir. 2008).

Indeed, the exception has been found inapplicable in vaccine cases where an individualized physician/patient relationship existed.

[B]ecause the physician-patient relationship existed, and because the doctor had thus assumed the role of learned intermediary, the fact that he had made no individualized judgment did not bar the application of the learned intermediary doctrine.

Hurley v. Lederle Laboratories, 863 F.2d 1173, 1179 (5th Cir. 1988) (applying Texas law).  See Niemiera v. Schneider, 555 A.2d 1112, 1118 (N.J. 1989) (learned intermediary rule applies because this “vaccine is administered in a doctor’s office on a case-by-case basis”); Stanback v. Parke, Davis & Co., 657 F.2d 642, 647 (4th Cir. 1981) (“The encounter in this case . . ., was between a patient and a physician whom she had previously visited on three occasions”); Dunn v. Lederle Laboratories, 328 N.W.2d 576, 580 n.11 (Mich. App. 1983) (“this case involves a single immunization to a single patient, administered by a physician, [so] . . . [defendant’s] duty to warn . . . extends only to the doctor”); Snawder v. Cohen, 749 F. Supp. 1473, 1480 (W.D. Ky. 1990) (defendant’s “duty extended no further than to provide a warning to Plaintiff’s physician . . ., since the administration of the vaccine . . ., apparently took place in a physician’s office”); Percival v. American Cyanamid Co., 689 F. Supp. 1060, 1062 (W.D. Okla. 1987) (“Nor do the facts give rise to the mass immunization exception.  [The prescriber] was the treating physician and had treated [plaintiff] numerous times”) (applying Oklahoma law); Williams v. Lederle Laboratories, Division of American Cyanamid Co., 591 F. Supp. 381, 389 (S.D. Ohio 1984) (“appropriate test . . . is whether the drug is commonly administered without individualized balancing by a physician of the risks involved and the individual’s needs and circumstances”) (applying Ohio law).

The lesson of the “mass vaccination” exception is thus that the learned intermediary rule is ousted only “when the manufacturer knows or should know that the advisory role of the health care provider will be greatly diminished.”  Larkin v. Pfizer, Inc., 153 S.W.3d 758, 765 (Ky. 2004).  The only basis for the exception is the attenuation of the physician-patient relationship.  But that is exactly the opposite of the purpose of telemedicine, described at length above, which is precisely to bring the benefits of individualized medical diagnosis and treatment to those who live too far from a physician (or for any other reason) to be able to receive medical treatment face to face.  Thus, our conclusion remains that, as long as “telemedicine” is what it claims be – “a primary care or allied health professional providing a consultation with a patient, or a specialist assisting the primary care physician in rendering a diagnosis” – there is no logical basis to challenge the applicability of the learned intermediary rule simply because that physician was not in the same room as the patient.

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

It’s not a long decision – but there’s still a lot to it.  Maybe that’s because there wasn’t a lot to plaintiff’s complaint. Regardless, Sharp v. St. Jude Medical, S.C., Inc., 2019 WL 3821895 (N.D.GA Aug. 14, 2019) makes some key defense rulings.

The case involves an implantable cardiac defibrillator (“ICD”) that plaintiff alleges malfunctioned and did not deliver the necessary shock when plaintiff’s husband went into cardiac arrest.  Plaintiff alleges the reason for the failure was friction between the insulation and the wires.  Id. at *1.  Plaintiff brought claims for manufacturing defect, failure to warn, and negligence per se.  Defendant raised by both preemption and TwIqbal grounds for dismissal.

In deciding the motion to dismiss, the court first held that plaintiff cannot state a viable manufacturing defect claim premised solely on allegations that the device malfunctioned.  Id. at *4.  A malfunction is not the equivalent of a defect and the latter cannot be inferred from the former.  Plaintiff also tried to rely on Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) to argue that she needed discovery of defendant’s PMAs before she could plead a parallel violation claim.  But Georgia is in the Eleventh Circuit where Wolicki-Gables v. Arrow Int’l, Inc., 634 F.3d 1296 (11th Cir. 2011) controls which requires the complaint “point to specific PMA requirement[s] that have been violated and not wait for discovery on such matters.”  Sharp at *4.

On failure to warn, the court starts by applying Georgia’s learned intermediary doctrine.  So any duty to warn extended to plaintiff’s husband’s physician.  Id. at *5.  In this case, the court also applied the sophisticated user doctrine which provides that a manufacturer need not warn a physician of risks from prescription medical devices that are “generally known” to physicians.  Id.  Having pointed to multiple public sources of information concerning the ICD leads at issue, the court was able to conclude that the risk was well-known in the medical community which barred plaintiff’s failure to warn claim.

Turning to preemption, plaintiff appears to allege different causes for the failure of the ICD but doesn’t link them to any specific PMA requirement that was allegedly violated.  Id. at *7.  Without a causal connection between the ICD implanted in plaintiff’s husband and a PMA violation, plaintiff’s claim is preempted.  The court didn’t even have to go that far on failure to warn, agreeing with defendant that “Plaintiff’s claim that Defendants should have provided additional or different warnings is preempted, no matter how the arguments are construed.”  Id.  Failure to warn premised on a failure to file a report with the FDA is the equivalent of “fraud-on-the-FDA” and therefore preempted.  Id.  The fact that the product was recalled does not change the preemption analysis.  Id.  And to the extent plaintiff tried to bring a claim for failure to provide adverse event reports directly to patients and physicians – that would be a state duty that exceeds federal requirements and is likewise preempted.  Id. at *8.

Finally, plaintiff’s negligence per se claim is impliedly preempted as an attempt at private FDCA enforcement.  Id.

Sometimes good things do come in small packages.  We’ll take a short, sweet, and solid defense win any day.

A little knowledge is a dangerous thing. A jack of all trades is a master of none. These cutesy little phrases throw some derision toward one who possesses some knowledge in a bunch of areas. Representing drug and device companies in litigation can make a lawyer reject the negative interpretation of these phrases. We have learned a bit here and there on a wide range of topics, some of which we have actually retained through the fog of time. When a decision touches on a number of areas where we know something, whether from litigation or the real world, we hubristically expect to be able to make sense of it. Spedale v. Constellation Pharms., No. CV-17-00109-PHX-JJT, 2019 U.S. Dist. LEXIS 139010 (D. Ariz. Aug. 16, 2019), was like that. It involved rulings on the defendant’s Daubert motion on plaintiff’s liability and causation expert and summary judgment motion in a case brought by a participant in a clinical trial for a cancer drug against the sponsor under principally product liability theories. We know something about those issues in general and the specific allegations about what animal studies showed, how that allegedly should have affected the clinical trial documents and enrollment, and the plaintiff’s alleged psychiatric injuries hit at least within the neighborhood of our bailiwick. Yet, the decision in Spedale did not make much sense to us, even focusing solely on the summary judgment ruling.

The basic facts are that plaintiff had been treated for multiple myeloma for six years at a prominent research institution. Early on in her care, she was diagnosed with mania related to one of the drugs in her treatment regimen, which resolved by adding another medication. Six years later, with her cancer worsening, she was offered the chance to participate in a clinical trial at the institution instead of switching to another marketed cancer drug. The clinical trial was a Phase 1 study proceeding under a sponsor-submitted IND, so it was relatively small, did not only include patients with multiple myeloma, and was set up to make clear to potential participants that little was known about how the experimental drug would work in humans. After a thorough informed consent process, the plaintiff was enrolled in the trial and began the study drug. Within three weeks, she was diagnosed with mania, which worsened and allegedly persisted for years after discontinuing the study drug. She and her husband—whose facts and claim we will ignore here—sued the sponsor of the clinical trial claiming that Arizona law provided relief for negligent misrepresentation, negligent drafting of the informed consent form, lack of informed consent, and strict liability in manufacture, design, and warnings for the drug. Plaintiff found an expert to say that the preclinical studies suggested a risk of mania not properly studied by the sponsor or disclosed in the informed consent document, that the sponsor inadequately warned the investigators, and that the study drug caused plaintiff’s mania. The sponsor offered fact and expert evidence about its compliance with FDA requirements, the appropriateness of the study design, the completeness of the consent documents, and plaintiff’s enrollment in and consent for the clinical trial by her treating physician and other investigators.

The challenges to the plaintiff’s expert excluded some of his opinions, but left intact his core opinions about the sponsor’s approved informed consent documents, its disclosures of risks to the investigators, and the causation of plaintiff’s (recurrent) mania. This is where we get a bit confused by the things the court did not consider and the order in which it considered the things it did. It seems to us that a predicate question, especially for a court sitting in diversity and paying due attention to Erie restraint, should be “Does established Arizona law permit tort claims by a clinical trial participant against the sponsor of a clinical trial?” Another important question to ask might be “In the case of a study under an IND, can a plaintiff recover under state law based on the contention that documents approved by FDA were inadequate without running afoul of preemption?” One could also ask “For analysis of proximate cause for the informational claims for this prescription drug, what did the prescribing physician say about the impact of additional information on his treatment of this plaintiff?” Sadly and somewhat surprisingly, the court did not really ask any of these questions in ruling on summary judgment.

Instead, the court walked through the claims in order and it was a mixed bag, allowing more of the case to go forward than we think made sense. First up were plaintiff’s purported negligence claims, framed as a whether the defendant provided the investigators with enough evidence about the risks and benefits of the study drug to allow for adequate informed consent. The court ruled, in a footnote, that factual allegation of an affirmative misrepresentation was unsupported because the approved informed consent documents did not claim the study drug was a treatment for multiple myeloma. The court characterized the claim not based on an affirmative representation as “negligent drafting.” Rather than examine whether Arizona law imposed such a duty, the court looked to whether federal law imposed duties that relate to the safety of study participants—they do—and what certain federal courts had said about those duties. Neither of the two cases the court cited concerned Arizona law. One, from the District of Massachusetts in 2014 has already drawn our ire for making up a new duty. Without saying it was predicting Arizona law or considering appellate decisions (like the cases cited here), the court followed that case and concluded a breach of a duty to the investigator could breach a duty to the study participant. That put the cart before the horse, but it also made it easy to conclude that there was a genuine issue whether the sponsor had breached a duty to plaintiff because her expert opined that it “failed to ‘monitor the site’s activities and documents.’” Thus, a novel duty of “negligent drafting” could be satisfied with expert evidence of failure to monitor. This was almost as befuddling as the ruling that there was a genuine issue on proximate causes solely based on plaintiff’s expert evidence of medical causation. If the breach was drafting consent documents or monitoring the site’s activities, then proximate cause would require some evidence about how the investigators would not have enrolled plaintiff and/or given her the study drug. It does not seem that plaintiff had any of that evidence.

On plaintiff’s claim for informed consent, the court again skipped the step of determining if Arizona recognized such a claim against a clinical trial sponsor, as opposed to a medical provider. Although not considered on the first claim, the court did consider the role of the learned intermediary doctrine, because this was a prescription drug and plaintiff’s self-serving testimony that different warnings to her would have affected her decision to participate in the trial should not matter on a warnings claim. The court’s reasoning for blowing past the learned intermediary doctrine and the lack of supporting evidence from the prescribing physician was as follows:

[I]f Defendant breached its duty of care to Ms. Spedale by failing to perform due diligence in the preclinical testing phase, the [informed consent documents] could also be deemed deficient for lack of material information. Because the fate of Plaintiffs’ informed consent claim rises and falls with their negligent drafting claim, the Court denies summary judgment with respect to Plaintiffs’ informed consent claim.

Given that the “negligent drafting claim” hinged on information provided to the learned intermediary, this hardly seems like a rationale for avoiding a consideration of the law and evidence.

Next up were strict liability claims for manufacturing defect and design defect. Here, the court actually considered Arizona law specific to the issues in the case. It quote an Arizona appellate decision that strict liability for sellers can “apply to those who manufacture and [s]upply products to consumers on an investigational basis.” It also analyzed Arizona cases on the two potential tests for design defect and determined that the lower bar “consumer expectation test” would not apply “[b]ecause experimental drugs are beyond the ordinary consumer’s knowledge and experience.” With the standards set, the analysis was fairly easy because plaintiff did not have evidence that the drug she took was not what it was supposed to be or that its risks exceeded its benefits. Thus, the defendant was granted partial summary judgment on these claims.

The consideration of the strict liability failure to warn claim, however, reverted to form without addressing the issues missing in the denial of summary judgment on the negligent drafting and informed consent claims. Even though the court hypothesized that additional preclinical testing might have detected something, it leapt to “if that knowledge would have removed someone with Ms. Spedale’s medical history from the participant population, Defendant is liable for the resulting informational defect” without evidence from the investigators supporting such a change.

Because this was Arizona, however, the defendant left with the prize of partial summary judgment on punitive damages. Arizona requires “clear and convincing evidence that the defendant engaged in aggravated and outrageous conduct with an evil mind.” The conduct of which plaintiff complained was not outrageous. That part made sense to us.

We have blogged several times about mass tort plaintiffs who failed to list their tort claims in prior bankruptcy proceedings, thereby stiffing their creditors. See here, for example. Do they get away with it? Usually not. Courts have routinely sent those tort plaintiffs packing, and two different theories call for that result: (1) lack of standing, and (2) judicial estoppel. See, e.g., In re Taxotere (Docetaxel) Prod. Liab. Litig., 2018 WL 5016219, at *6-7 (E.D. La. Oct. 16, 2018) (granting summary judgment and holding that plaintiff is estopped from pursuing her claims against defendant because “the Chapter 7 Trustee is the real party in interest in this litigation”).

Recently, we ran into a tort plaintiff who tried to escape this outcome by arguing that: (1) as a Chapter 13 bankruptcy debtor, she had standing, and (2) judicial estoppel should not apply because her failure to disclose the tort claim in bankruptcy was an innocent mistake – – all the more understandable because the tort claim did not arise until after she filed for bankruptcy and after her reorganization plan was confirmed.

It occurs to us that these issues might not be so rare, so we thought we’d share some quick and dirty learning with you.


Lack of standing is clear in Chapter 7 cases. See 11 U.S.C. § 541(a)(1) (upon commencement of a bankruptcy proceeding, “all legal or equitable interests of the debtor in property” become property of the bankruptcy estate); see also Newman v. Enriquez, 869 N.E.2d 735, 741 (Ohio Ct. App. 2007) (“Upon the commencement of a bankruptcy case, all of a debtor’s property becomes property of the estate … includ[ing] any unliquidated legal claims.”) (internal citations omitted).

Chapter 13 is a bit messier. But wait a minute, you ask, what is the difference between Chapter 7 and Chapter 13? Chapter 7 is a liquidation bankruptcy as opposed to Chapter 13, which is a rehabilitation bankruptcy. (In the corporate context, the juxtaposition is liquidation vs. a Chapter 11 reorganization.) In a Chapter 7 bankruptcy, all nonexempt property becomes the property of the trustee, who must liquidate that property to satisfy secured creditors. So as of the time of filing a Chapter 7 bankruptcy petition, a debtor’s interest in any pending civil action immediately becomes the property of the debtor’s bankruptcy estate. See, e.g., Northland Ins. Co. v. The Illuminating Co., 2004 WL 612889, at *2-4 (Ohio Ct. App. March 29, 2004) (dismissing claims on grounds that plaintiff lacked standing because civil claims are the property of the bankruptcy estate). But in a Chapter 13 bankruptcy, the debtor maintains ownership in the property that is not included in the repayment plan, although the debtor is required to repay secured creditors in full and unsecured creditors in an amount equal to the value of nonexempt assets pursuant to a rehabilitation plan. See 11 U.S.C. § 1306(b) (“Except as provided in a confirmed plan or order confirming a plan, the debtor shall remain in possession of all property of the estate.”).

What did we mean when we said that standing is messier under Chapter 13? There are some cases suggesting that Chapter 13 debtors lack standing outright. See, e.g., Richardson v. United Parcel Service, 195 B.R. 737, 739 (E.D. Mo. 1996) (“only the trustee is authorized to pursue a cause of action”); In re Bryer, 216 B.R. 755 (E.D. Pa. 1998). But there are also cases suggesting that a debtor has standing to pursue claims. Olick v. Parker & Parsley Petroleum Co., 145 F§ .3d 513, 515-16 (2d Cir. 1998); Ponton v. AFSCME, 395 F. App’x 867, 871 (3d Cir. 2010).

The standing of a Chapter 13 debtor seemingly rests upon the distinction between the debtor pursuing the claims for the benefit of the estate or for his or her own benefit. Thus, even Chapter 13 cases talk about standing to bring action on behalf of the estate. See, e.g., Autos, Inc. v. Gowin, 244 F. App’x 885, 889 (10th Cir. 2007) (unpublished) (the “case for standing [was] particularly compelling” because the debtor was “pursuing a claim ostensibly for the benefit of estate with the knowledge and consent of the trustee”); see also Ponton, 395 F. App’x at 871, n.1 (citing Smith v. Rockett, 522 F.3d 1080, 1081 (10th Cir. 2008) (Chapter 13 debtors held to have standing “to bring claims in their own name on behalf of the bankruptcy estate”)). Notably though, the dissent by Judge O’Brien in Rockett pointed out that there is no language in the bankruptcy code granting Chapter 13 debtors capacity to sue in their own name, even on behalf of the estate, and declared the decision “unwarranted and unwise.” It is a very good dissent. But it is a dissent. In any event, are the mass tort plaintiffs trying to sue on behalf of the estate? No, they are not. The beneficiaries of the tort claims are the plaintiffs – and their lawyers.

Under Chapter 13 there is also the issue of timing. If the tort claim is never disclosed, then when does it become property of the bankruptcy estate? What if the tort claim ripens after the initial bankruptcy petition? Plan confirmation is certainly a measuring point in a Chapter 13 case where full disclosure has been made, and it is not unusual for plans to be modified or amended. So, what about a claim that arises after a plan is confirmed, but then amended? That claim must be disclosed so that the bankruptcy trustee may determine how it should be allocated, and whether the claim reverts back to the debtor. Undisclosed assets remain property of the bankruptcy estate – it’s that simple. In re Waldron, 536 F.3d 1239, 1242 (11th Cir. 2008); see also Rainey v. United Parcel Serv., Inc., 466 F. App’x 542, 544 (7th Cir. 2012) (“A Chapter 13 estate encompasses all property, including legal claims, acquired after the petition is filed and before the case is closed.”); Barbosa v. Solomon, 235 F.3d 31, 36–37 (1st Cir. 2000) (“[P]roperty of the estate at the time of confirmation vests in the debtors free of any claims from the creditors. The estate does not cease to exist however, and it continues to be funded by the Debtors’ regular income and post petition assets as specified in section 1306(a).”); In re Gonzales, 587 B.R. 363, 370 (Bankr. D.N.M. 2018). Those assets can be pre- or post-petition.

    Judicial Estoppel

Even if your jurisdiction deems a Chapter 13 debtor to have standing to pursue claims on behalf of the bankruptcy estate, judicial estoppel may operate to bar those claims. For instance, though the court in Autos, Inc. held that the debtor had standing to pursue undisclosed claims, it also held that failure to disclose compelled dismissal of the case. 244 F. App’x at 889 (judicial estoppel applies against a Chapter 13 debtor who failed to list a lawsuit as an asset in prior bankruptcy case).

Let’s go back to basics for a moment. For estoppel to apply, the plaintiff must have (i) taken inconsistent positions in two different courts, and (ii) the former position must have been accepted by the first court. See, e.g., Browning v. Levy, 283 F.3d 761 (6th Cir. 2002). Plaintiffs who did not disclose their tort lawsuits, and who have had their plans confirmed or bankruptcies discharged, clearly meet this standard. The only way for a plaintiff in this instance to avoid dismissal is to allege “inadvertence.” A legal term of art in the judicial estoppel context, inadvertence is shown only when either (i) the debtor lacks knowledge of the factual basis of the undisclosed claims, or (ii) where the debtor has no motive for concealment. Id. at 776. Motive for concealment will always be clear in the bankruptcy context (the financial motive to avoid paying your creditors part of any potential award). Thus, the question really becomes: when does the plaintiff “lack knowledge of the factual basis of the undisclosed claims”? The factors that help answer that question will vary by jurisdiction, but it is certainly the case that once a tort lawsuit has been filed, no plaintiff can claim inadvertence under a theory of lack of knowledge.

But what about the tort plaintiff’s argument that this was all too complicated and that she did not mean to stiff her creditors – even if that is the happy, unintentional result? The burden to prove “inadvertence” is on the plaintiff. In re Taxotere, 2018 WL 5016219, at *4 (“[T]o establish a defense of inadvertence, a party has to prove (1) that he or she did not know about the inconsistency or (2) that he or she lacked a motive for concealment.”). Just saying “I did not mean it” does not get you off the hook. Mind you, there are some cases where plaintiffs were able to come forth with good reasons for their omission. See Hanley v. Trizetto Corp., 2014 WL 4212719 (D. Colo. 2014) (the debtor was misled by her lawyer who advised her that her legal claim should not be disclosed in bankruptcy; plus, she sought to reopen her bankruptcy and list the claim before the discrepancy was raised by the defendant; plus, she agreed to pay the estate a lump sum plus a percentage of any recovery). Byrd v. Wyeth, Inc., 907 F. Supp. 2d 803 (S.D. Mississippi 2012). But if the debtor-tort claimants do not have that something like that extraordinary concatenation of hardships/equities, they are in the soup, which means that your client might get out of the soup for that particular case.


In our case, the plaintiff argued that the nondisclosure of her tort lawsuit was all much ado about nothing, because the bankruptcy laws of her home state shielded her personal injury claims from the grasping hands of her creditors. It is true, to be sure, that such state law exemptions are applied – but take a careful look at the scope of such exemptions. Personal injury damages are not the same thing as punitive damages. We told the plaintiff lawyers we’d drop our standing/estoppel arguments if they’d drop their claim for punitive damages. Guess what their response was? They actually never did respond. We’d call that nonresponse rather telling.

Bexis is updating the preemption chapter of his prescription medical product liability treatise, and with Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (U.S. 2019), being so new, he collected a bunch of law firm blogs/client updates about the case to see what potential issues other lawyers out there might have spotted.  Bexis didn’t limit himself to the defense side.  Indeed, one of the most intriguing comments came from Motley Rice:

I read this to mean that where the “facts” concerning clear evidence are in dispute, the Court must essentially apply a summary judgment test and hold the claims preempted only where, on the undisputed evidence, it is clear that the FDA rejected the warning that state law requires with full knowledge of all material information concerning the proposed warning.

Evaluating what the Supreme Court had just declared to be “a legal question for judges” 139 S. Ct. at 1680, by a “summary judgment test” seemed odd to us.  We’ve always considered the summary judgment standard – that facts, and factual inferences, must be viewed in “the light most favorable” to the non-moving party (almost always the plaintiff in preemption cases) – exists because ultimately the evidence is being evaluated with an eye towards factual disputes being determined by juries.

That’s most emphatically not what is supposed to happen with preemption after Albrecht, since the Court held:

We understand that sometimes contested brute facts will prove relevant to a court’s legal determination about the meaning and effect of an agency decision. . . .  But we consider these factual questions to be subsumed within an already tightly circumscribed legal analysis.  And we do not believe that they warrant submission alone or together with the larger pre-emption question to a jury.  Rather, in those contexts where we have determined that the question is for the judge and not the jury, we have also held that courts may have to resolve subsidiary factual disputes that are part and parcel of the broader legal question.

139 S. Ct. at 1680 (citation and quotation marks omitted) (emphasis added).  Indeed, Albrecht specified how judges are to arrive at preemption rulings – rejecting any thumbs being put on the scales of justice.  “[T]he judge must simply ask himself or herself whether the relevant federal and state laws irreconcilably conflict.”  Id. at 1679.

The Albrecht Court also found preemption analogous to the construction of patents, relying on a 1996 patent decision in Markman v. Westview Instruments, Inc., 517 U. S. 370 (1996), which had found evaluation of patent terms to be a legal issue.  139 S. Ct. at 1680.  That means that over 20 years of patent precedent exists that would have addressed whether or not a summary judgment standard applies to such “subsumed” factual issues.

So we took a look.

We were right – meaning that the Motley blogpost was largely wishful thinking.  With the patent construction issue solely for the court, not a jury, the pool of evidence relevant to that legal determination has consistently been weighed in patent cases without courts invoking any “most favorable” summary judgment standard applicable to the patent issue.  Indeed, it is often a striking difference, since patent construction is often discussed in close proximity to the ultimate issue of whether infringement has occurred, the latter being a jury question to which the “most favorable” review standard still applies.

After Markman, a two-step process that has developed in patent cases – first a judicial construction of the patent itself (sometimes involving a so-called “Markman hearing” to address factual questions), followed by, second, a jury deciding whether the patent (as construed by the court) was infringed by whatever the defendant had done.  Critically, the “most favorable” summary judgment standard only applies to the infringement question – not the court’s prior construction of the patent.

A court determines patent infringement by construing the claims and then applying that construction to the accused process or product.  This court reviews claim construction without deference.  In the context of summary judgment, this court reviews the second determination for genuine disputes of material facts that would preclude a grant of summary judgment.  Thus, [the moving defendant] is entitled to summary judgment of no infringement only if the facts and inferences, when viewed in the light most favorable to [plaintiff], would not persuade a reasonable jury to return a verdict in favor of [plaintiff], the non-moving party.

Business Objects, S.A. v. Microstrategy, Inc., 393 F.3d 1366, 1371-72 (Fed. Cir. 2005) (emphasis added).  For additional appellate patent decisions making essentially the same holding – whether or not the defendant was ultimately entitled to summary judgment – see, e.g., Searfoss v. Pioneer Consolidated Corp., 374 F.3d 1142, 1148 (Fed. Cir. 2004); Advanced Cardiovascular Systems, Inc. v. Scimed Life Systems, Inc., 261 F.3d 1329, 1336 (Fed. Cir. 2001); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1304 (Fed.Cir. 1999).

Indeed, for present purposes, patent cases that defendants lose are more significant than those they win.  For example take, Advanced Cardiovascular.  The Federal Circuit reversed because it concluded that “summary judgment was based on an erroneous construction of [several patent] terms.”  Id. at 1331.  The Federal Circuit spent several pages (id. at 1332-36, 1341-44) critiquing the district court’s patent construction, including “extrinsic evidence.”  Not once did the Federal Circuit in Advanced Cardiovascular state that anything was to be construed in a “light most favorable” to the non-movant.  That standard was irrelevant.  “The parties’ arguments present a question of claim construction.”  Id. at 1343.

Thus, based on:  (1) the Albrecht Court’s description of how judges should approach the legal issue of preemption – “simply” deciding whether or not a preemptive conflict exists; and (2) how patent construction issues have been treated after Markman, we believe that it’s time to end the summary judgment practice of viewing facts “most favorably” to the non-moving party in preemption cases.  With nothing for a jury to decide, preemption is a straight up legal issue, like patent construction, to which plaintiff-friendly standards of review “simply” don’t apply.

Here is the third and final part of our 50-state opus on precedent supporting the principle that plaintiffs asserting claims dependent on propositions that ordinary people aren’t expected to know must come forward with expert opinions for those propositions.  As mentioned previously, this project arose from something we read about in the Mirena litigation – but it metastasized.  Part three covers from Pennsylvania through Wyoming.  Because we didn’t want to split Pennsylvania, this part is a little longer, and part two a little shorter, than average.

What we intend to do now, once our readers have had a chance to digest this, is consolidate the entire 50-state post in what is now part one of this survey.  That way, going forward, those of you who wish to consult this research will only have to look in one place.


Pennsylvania precedent is explicit that “[e]xpert testimony in support of the plaintiff’s claim is an indispensable requirement in establishing a plaintiff’s right of action” whenever “the treatment and injury typically involved are such that the common knowledge or experience of a layperson is insufficient to form the basis for passing judgment.”  Mitchell v. Shikora, 209 A.3d 307, 315 (Pa. 2019).  “[C]ausation is also a matter generally requiring expert testimony.”  Toogood v. Rogal, 824 A.2d 1140, 1145 (Pa. 2003).  Where “the complexities of the human body place questions as to the cause of pain or injury beyond the knowledge of the average layperson,” Pennsylvania requires expert testimony “that the injury in question did, with a reasonable degree of medical certainty, stem from” the act alleged.  Hamil v. Bashline, 392 A.2d 1280, 1285 (Pa. 1978).

Where, however, the ultimate determinations lie beyond the knowledge or expertise of the average layperson, expert testimony is permitted (and sometimes required) to aid the jury in its understanding of the factors involved and the teaching of the pertinent discipline with respect thereto. . . .   For a plaintiff to make out his cause of action in such a case, therefore, the law requires that expert medical testimony be employed.

Id. (citations omitted).  Accord, e.g., Smith v. German, 253 A.2d 107, 109 (Pa. 1969) (“plaintiff was required to offer expert testimony in order to establish the medical connection” to the accident); Dornon v. Johnston, 218 A.2d 808, 809 (Pa. 1966) (“expert guidance is necessary” whenever an issue is “sufficiently obscure that laymen are unable to make a reasonable determination as to its existence”); Grossman v. Barke, 868 A.2d 561, 567 (Pa. Super. 2005) (“causation is also a matter generally requiring expert testimony” because “a jury of laypersons generally lacks the knowledge to determine the factual issues”) (citation and quotation marks omitted); McMunn v. Babcock & Wilcox Power Generation Group., Inc., 869 F.3d 246, 267 (3d Cir. 2017) (“Expert evidence is generally required when an issue is beyond the ken of a lay jury.”) (applying Pennsylvania law); Cabrera v. Ross Stores, LP, 646 F. Appx. 209, 211 (3d Cir. 2016) (“expert testimony was necessary to establish the causation element of [plaintiff’s] suit”) (applying Pennsylvania law); Furlan v. Schindler Elevator Corp., 516 F. Appx. 201, 207 (3d Cir. 2013) (“[plaintiffs] were unable to meet their burden to establish a claim of negligent maintenance . . . with the exclusion of [their] expert testimony”) (applying Pennsylvania law); Gates v. Rohm & Haas Co., 655 F.3d 255, 265 (3d Cir. 2011) (“[e]xpert testimony is required to prove” the elements of medical monitoring) (quoting Sheridan v. NGK Metals Corp., 609 F.3d 239, 251 (3d Cir. 2010)) (applying Pennsylvania law); Estate of Aptekman v. City of Philadelphia, 127 F. Appx. 619, 622 (3d Cir. 2005) (“Where the causal nexus is not patently obvious, and there is no expert opinion, a factfinder could not simply infer a causal connection.”) (applying Pennsylvania law); In re TMI Litigation, 193 F.3d 613, 723 (3d Cir. 1999) (affirming summary judgment after affirming exclusion of plaintiffs’ experts) (applying Pennsylvania law); Redland Soccer Club, Inc. v. Dept. of Army, 55 F.3d 827, 852 (3d Cir. 1995) (quoting and following Hamil) (applying Pennsylvania law); N’Jai v. Bentz, 2016 WL 7404550, at *3 (W.D. Pa. Dec. 22, 2016) (“Pennsylvania and Federal courts have consistently rejected a plaintiff’s attempt to establish causation in a toxic tort case without supplying expert testimony.”), aff’d, 705 F. Appx. 126 (3d Cir. 2017); Ely v. Cabot Oil & Gas Corp., 2014 WL 12479991, at *10 (Mag. M.D. Pa. March 28, 2014) (“The law is well-established that claims for physical injury based upon alleged pollution or other torts generally require probative medical evidence.”), adopted, 2014 WL 12489767 (M.D. Pa. July 29, 2014); Kemmerer v. State Farm Insurance Co., 2004 WL 87017, at *3 (E.D. Pa. Jan. 19, 2004) (“In a case involving complex issues of causation not readily apparent to the fact finder, plaintiff must present admissible expert testimony to carry her burden.”); Fritz v Grossinger, 2009 WL 7039662 (Pa. C.P. Sept. 5, 2009) (“complex medical issues appertain to the determination of whether it was the remnant of the [medical device] . . . or some other cause that resulted in the alleged pain” and other injuries).

The same is true in Pennsylvania product liability litigation.  A “total lack of causation evidence absent the expert testimony . . . is a proper ground for summary judgment.”  Heller v. Shaw Industries, Inc., 167 F.3d 146, 165 (3d Cir. 1999) (applying Pennsylvania law).  “[E]xpert opinion on the effectiveness of the alternative design . . . [i]s required.”  Dunlap v. Federal Signal Corp., 194 A.3d 1067, 1073 (Pa. Super. 2018).

Pennsylvania law recognizes that proving the elements of these claims in complex tort cases often requires presentation of expert testimony. . . .  In other complex tort actions, such as product liability cases, courts have also opined that expert witnesses are often necessary to establish liability.  Further, courts recognize that there are consequences which flow from a failure to provide such proof.  Where a tort action turns on allegations of a technical nature relating to some alleged defect in a product, and the Plaintiff has failed to provide expert proof identifying the defect in the product or drawing a causal connection between that allegedly defective product and the Plaintiff’s injuries, courts have held that product liability and related negligence claims fail as a matter of law and must be dismissed.

Ruehl v. S.N.M. Enterprises, Inc., 2017 WL 5749560, at *1 (M.D. Pa. Nov. 28, 2017) (quoting American Power, LLC., v. Speedco Inc., 2017 WL 4084060, at *6 (M.D. Pa. Jan. 17, 2017) (citations omitted)).  See Nobles v. Staples, Inc., 150 A.3d 110, 120 (Pa. Super. 2016) (“exclusion of [plaintiff’s] expert made it impossible for [plaintiff] to prove” product liability even under a malfunction theory); Brandon v. Ryder Truck Rental, Inc., 34 A.3d 104, 110 (Pa. Super. 2011) (“an expert is necessary for [plaintiff] to prove his negligence claim against [defendant], and absent the testimony of a qualified expert, a jury’s verdict would be nothing more than conjecture”); Goldstein v. Phillip Morris, Inc., 854 A.2d 585, 589 (Pa. Super. 2004) (once plaintiff’s expert was “properly struck by the trial court . . . [plaintiff] had no means of establishing alleged specific defects in the [product]”); McCracken v. Ford Motor Co., 392 F. Appx. 1, 3 (3d Cir. 2010) (plaintiff “was required to support his claims of strict products liability and defective design with expert testimony”) (applying Pennsylvania law); Cabrera v. Ross Stores, LP, 646 F. Appx. 209 (3d Cir. 2016) (“expert testimony was necessary to establish the causation element of [plaintiff’s] suit”) (applying Pennsylvania law); Oddi v. Ford Motor Co., 234 F.3d 136, 159 (3d Cir. 2000) (“Inasmuch as [plaintiff’s] ‘defect expert’ does not survive Daubert scrutiny, the district court properly granted summary judgment to [defendants]”) (applying Pennsylvania law); Koplove v. Ford Motor Co., 795 F.2d 15, 18 (3d Cir. 1986) (“a rational jury could not find the defendant liable without some expert analysis of the available information which implicated it”) (applying Pennsylvania law); Bibbs v. SEPTA, 2012 WL 8704635, at *3 (Pa. Commw. April 13, 2012) (“Plaintiff was required to present expert testimony to establish that [product’s] defect . . . was the legal cause of Plaintiff’s injuries”); Hook v. Whiting Door Manufacturing Corp., 2019 WL 630324, at *6 (W.D. Pa. Feb. 14, 2019) (“where the issues in a products liability case are highly technical, expert testimony is necessary to assist the jury in understanding the claims”); White v. Home Depot, Inc., 2018 WL 2173960, at *4 (E.D. Pa. May 10, 2018) (summary judgment granted after defect expert excluded); McCracken v. R.J. Reynolds Tobacco Co., 2019 WL 635430, at *7 (E.D. Pa. Feb. 14, 2019) (quoting Lamar); Metil v. Core Distribution, Inc., 2018 WL 3707421, at *8 (W.D. Pa. Aug. 3, 2018) (“Absent [plaintiff’s] expert testimony relating to the cause of the accident and whether a design defect existed . . ., Plaintiff cannot support his theory of the case”); Bailey v. B.S. Quarries, Inc., 2017 WL 4366987, at *3 (M.D. Pa. Sept. 29, 2017) (“a product liability claim must be supported by expert witness testimony”); Hatcher v. SCM Group, Inc., 167 F. Supp.3d 719, 730 (E.D. Pa. 2016) (“without the expert report, there is no genuine dispute of material fact”); Inman v. General Electric Co., 2016 WL 5106939, at *9 (W.D. Pa. Sept. 20, 2016) (courts “routinely require plaintiffs to support their claims with expert testimony when the subject matter is highly technical and beyond the jury’s understanding”); Rabadi v. Great Wolf Lodge of the Poconos LLC, 2016 WL 4238638, at *5 (M.D. Pa. Aug. 9, 2016) (“Where, as here, a plaintiff fails to proffer the required expert evidence in response to a properly supported motion for summary judgment, summary judgment is appropriate.”) (citation and quotation marks omitted); Harris v. Oz Directional Drilling, Inc., 2016 WL 4578150, at *4 (Mag. M.D. Pa. June 30, 2016) (same as Ruehl), adopted, 2016 WL 4698635 (M.D. Pa. July 19, 2016); Webb v. Tahsin Industrial Corp., 2016 WL 454821, at *7 (M.D. Pa. Feb. 5, 2016) (“Lacking this expert evidence, Plaintiff’s claims must fail, and Defendant is entitled to an entry of summary judgment in its favor.”); Yoder v. Sportsman’s Guide, Inc., 2015 WL 7009547, at *12 (W.D. Pa. Nov. 12, 2015) (“the Court will enter summary judgment in Defendants’ favor as Plaintiffs do not present admissible expert evidence”); Rupert v. Ford Motor Co., 2015 WL 757402, at *9 (W.D. Pa. Feb. 23, 2015) (summary judgment granted after exclusion of plaintiff’s expert), aff’d, 640 F. Appx. 205 (3d Cir. 2016); Curry v. Royal Oak Enterprises, LLC, 2013 WL 3196390, at *7 (E.D. Pa. June 25, 2013) (“in a products liability case . . ., plaintiff must provide expert evidence to establish liability”) (citing Oddi); Ellis v. Beemiller, Inc., 910 F. Supp.2d 768, 774 (W.D. Pa. 2012) (“Expert testimony is required . . . if the subject matter is beyond the comprehension of the average juror”); Lamar v. Saks Fifth Ave., Inc., 2012 WL 12897909, at *2 (E.D. Pa. Oct. 23, 2012) (“under Pennsylvania law, in a case regarding the cause of pain or physical injury, a plaintiff must produce medical testimony”) (citing Hamil); Shecktor v. Louisville Ladder, Inc., 2012 WL 5052577, at *5 (M.D. Pa. Oct. 18, 2012) (“In the absence of that expert causation testimony . . . the Court is compelled to enter judgment in the Defendant’s favor.”); Westfield Insurance v. Detroit Diesel Corp., 2012 WL 1611311, at *4 (W.D. Pa. May 8, 2012) (“expert testimony is generally required in products liability cases where a defect is alleged, unless the issues are ‘simple’ and ‘within the range of comprehension of the average juror.’”); Mendoza v. Gribetz International, Inc., 2011 WL 2117610, at *3 (E.D. Pa. May 27, 2011) (“Expert testimony is generally required to sustain a products liability case.”) (citing Oddi); Maldonado v. Walmart Store No. 2141, 2011 WL 1790840, at *14 (E.D. Pa. May 10, 2011) (“Without the evidence of Plaintiff’s experts, Plaintiff has failed to offer sufficient evidence of causation”); Shannon v. Hobart, 2011 WL 442119, at *6 (E.D. Pa. Feb. 8, 2011) (“without expert testimony, a reasonable jury could not find from this evidence that the [product] contained a manufacturing or design defect that caused [plaintiff’s] injuries”); State Farm Fire & Casualty Co. v. Gopher Baroque Enterprises, Ltd., 2010 WL 5464767, at *6 (E.D. Pa. Dec. 29, 2010) (“Where the cause of an injury is arguably complex, a party must produce expert testimony on causation to survive a motion for summary judgment.”); Chubb v. On-Time Wildlife Feeders, 578 F. Supp.2d 737, 740 (M.D. Pa. 2008) (“Because a reasonable juror could not make a reasonable determination on [plaintiff’s] theory of liability without an expert witness, and [plaintiff’s] expert witness was precluded from testifying, there is no genuine issue of material fact to go to a jury.”); Thomas v. Hamilton Beach/Proctor-Silex, Inc., 2007 WL 2080485, at *7 (W.D. Pa. July 13, 2007) (“expert medical testimony is required to establish the requisite causal connection”); Marino v. Maytag Corp., 2005 WL 2403638, at *4 (W.D. Pa. Sept. 29, 2005) (“a juror could not look at the [plaintiff’s] evidence] without expert testimony to explain it”); Fabrizi v. Rexall Sundown, Inc., 2004 WL 1202984, at *12 (Mag. W.D. Pa. June 2, 2004) (“Where a plaintiff fails to present admissible expert testimony regarding causation, courts routinely have granted summary judgment in favor of the defendant.”) (citations omitted), adopted (W.D. Pa. June 24, 2004); Jones v. Toyota Motor Sales, USA, Inc., 282 F. Supp.2d 274, 277 (E.D. Pa. 2003) (“engineering, medical, and biomechanical analysis is not within the know-how of the ordinary layperson, and thus requires expert evidence”), aff’d, 94 F. Appx. 879 (3d Cir. 2004); Gower v. Savage Arms, Inc., 2002 WL 1833344, at *2 (E.D. Pa. June 12, 2002) (“Without expert testimony that the [product] was defective . . ., the plaintiffs cannot make out a design defect claim.”) (citations omitted); Booth v. Black & Decker, Inc., 166 F. Supp.2d 215, 223 (E.D. Pa. 2001) (“Without expert testimony, a reasonable jury could not find from this evidence that the [product] contained a manufacturing or design defect that defect caused the [accident].”); Rapp v. Singh, 152 F. Supp.2d 694, 707 (E.D. Pa. 2001) (“Absent such expert testimony, plaintiff cannot establish that the [product] was defective, or that [there is] a safer design.”); Chester Valley Coach Works, Inc. v. Fisher-Price, Inc., 2001 WL 1160012, at *13 (E.D. Pa. Aug. 29, 2001) (“Without his expert testimony, Plaintiffs lack sufficient evidence to establish the cause of the [accident].”); Pappas v. Sony Electonics, Inc., 136 F. Supp.2d 413, 427 (W.D. Pa. 2000) (“Absent [their expert’s] testimony, plaintiffs’ claims under Pennsylvania law cannot survive . . . summary judgment.”); Hodge v. Caterpillar, Inc., 1992 WL 98415, at *2 (E.D. Pa. April 30, 1992) (“expert opinion or analysis is a prerequisite to proof of a defective product”); Niklaus v. Vivadent, Inc., 767 F. Supp. 94, 96 (M.D. Pa. 1991) (“Pennsylvania law is clear that in a personal injury case when there is no obvious causal relationship between the accident and the injury, unequivocal medical testimony is necessary to establish the causal connection.”) (citation and quotation marks omitted); Blase v. Allied Signal, Inc., 36 Pa. D. & C.4th 491, 500 (Pa. C.P. 1996) (“complexities coupled with the intricacies of asbestos exposure require the presentation of expert medical testimony”).

The requirement for expert testimony is strongly enforced in Pennsylvania prescription medical product liability litigation.  In a medical device case, “the cause of [plaintiff’s] injury was something that could only be determined by the jury through expert medical testimony.”  Polett v. Public Communications, Inc., 126 A.3d 895, 931 (Pa. 2015).  “When the complexities of the human body place questions as to the cause of pain or injury beyond the knowledge of the average layperson, Pennsylvania requires expert testimony.”  Singer v. Eli Lilly & Co., 396 F. Appx. 715, 716 (2d Cir. 2010)) (applying Pennsylvania law).

In a case such as this one involving complex issues of causation not readily apparent to the finder of fact, plaintiff must present admissible expert testimony to carry her burden.  If [plaintiff’s] expert testimony cannot support both general and specific causation, summary judgment for the defendant must be granted.

Soldo v. Sandoz Pharmaceuticals Corp., 244 F. Supp.2d 434, 525 (W.D. Pa. 2003) (citing Heller).  Expert support is also mandatory in warning claims.

Expert testimony is admissible when it involves explanations and inferences not within the ordinary training, knowledge and experience of the jury. . . .  Certain questions cannot be determined intelligently merely from the deductions made and inferences drawn from practical experience and common sense.  On such issues, the testimony of one possessing special knowledge or skill is required in order to arrive at an intelligent conclusion.  In these matters, where laymen have no knowledge or training, the court and jury are dependent on the explanations and opinions of experts. . . .

Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect.  The terms and applications of a warning on such a drug, in order to have meaning, must be explained to the jury.  This is a subject so distinctively related to some science, profession, business or occupation as to be beyond the ken of the average layman.  Thus, we hold that in a complex products liability action such as this, expert testimony is required to determine whether the drug manufacturer’s warning to the medical community is adequate.

Dion v. Graduate Hospital, 520 A.2d 876, 881 (Pa. Super. 1987) (citations and quotation marks omitted).  See Demmler v. SmithKline Beecham Corp., 671 A.2d 1151, 1154 (Pa. Super. 1996) (“expert medical testimony is required to determine whether the drug manufacturer’s warning to the medical community is adequate”); Atkinson v. Ethicon, Inc., 2019 WL 3037304, at *4 (W.D. Pa. July 11, 2019) (“Plaintiffs’ claims fail because the claims require an expert report to establish causation”); In re Zoloft (Sertraline hydrochloride) Products Liability Litigation, 176 F. Supp.3d 483, 498 (E.D. Pa. 2016) (summary judgment granted; “Without admissible expert testimony . . ., Plaintiffs instead have cobbled together . . . biological plausibility, specific causation opinions based on an assumption that general causation has been established, and anecdotal evidence”) (footnote omitted), aff’d, 858 F.3d 787 (3d Cir. 2017); Young v. Pfizer, Inc., 2016 WL 1569472, at *3 (E.D. Pa. April 19, 2016) (Pennsylvania law “require[s] expert testimony when medical causation is at issue”); Kline v. Zimmer Holdings, Inc., 2015 WL 4077495, at *26 (W.D. Pa. July 6, 2015) (summary judgment granted; “the adequacy of a warning in prescription medical device cases generally must be proven by expert testimony”), aff’d, 662 F. Appx. 121 (3d Cir. 2016); Williams v. Wyeth, Inc., 2013 WL 3761107, at *2 (E.D. Pa. July 18, 2013) (“Plaintiff must provide expert medical testimony demonstrating that . . . Defendants’ products were a substantial factor in causing Plaintiff’s [injury]”); Fenelon v. Pfizer, Inc., 2012 WL 13173126, at *3 (S.D.N.Y. May 7, 2012) (“[w]ithout an expert, [plaintiff] cannot prove that [the drug] was the cause of [the] death”) (applying Pennsylvania law); Pusey v. Becton Dickinson & Co., 794 F. Supp.2d 551, 565 (E.D. Pa. 2011) (granting summary judgment after excluding plaintiff’s expert); Aaron v. Wyeth, 2010 WL 653984, at *9 (W.D. Pa. Feb. 19, 2010) (“the adequacy of a warning in prescription drug cases must be proven by expert testimony”); Mracek v. Bryn Mawr Hospital, 610 F. Supp.2d 401, 406 (E.D. Pa. 2009) (“without an expert report, [plaintiff] cannot establish that the [medical device] had a defect”), aff’d, 363 F. Appx. 925 (3d Cir. 2010); Dick v. American Home Products Corp., 2009 WL 1542773, at *4 (M.D. Pa. June 2, 2009) (“a plaintiff must produce expert medical testimony in order to prove that an allegedly defective product caused medical injury”); (lack of expert testimony was a “complete failure of proof as to this essential [causation] element of all of [plaintiff’s] claims [and] mandates the entry of summary judgment”); Perry v. Novartis Pharmaceuticals Corp., 564 F. Supp.2d 452, 473 (E.D. Pa. 2008) (“Because we have judged [plaintiff’s expert] evidence inadmissible . . ., we must also grant defendant’s motion for summary judgment.”); Soufflas v. Zimmer, Inc., 474 F. Supp.2d 737, 751 (E.D. Pa. 2007) (“Generally, the adequacy of a warning in prescription medical device cases must be proven by expert testimony.  This case is no different.”) (citing Demmler); Schmerling v. Danek Medical, Inc., 1999 WL 712591, at *10 (E.D. Pa. Sept. 10, 1999) (after experts excluded, “complete failure of proof as to [causation] of all of her claims mandates the entry of summary judgment”); O’Brien v. Sofamor, S.N.C., 1999 WL 239414, at *6 (E.D. Pa. March 30, 1999) (summary judgment granted after excluding plaintiff’s experts); Burton v. Danek Medical, Inc., 1999 WL 118020, at *5 (E.D. Pa. March 1, 1999) (“Absent admissible expert testimony that the [medical] device caused [their] injuries, Plaintiffs are unable to prevail on any of their claims.”); In re Risperdal Litigation, 2017 WL 3496520, at *5 (Pa. C.P. July 26, 2017) (“In the absence of expert testimony, Plaintiff cannot establish the warnings are inadequate.”) (citing Dion); Commonwealth v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 13 Pa. D. & C. 5th 187, 203 (Pa. C.P. 2010) (“expert medical testimony is required to determine whether the drug manufacturer’s warning to the medical community is adequate”); Lawrence v. Synthes, Inc., 2002 WL 32747667, at *24 (Pa. C.P. July 25, 2002) (“there can be no doubt that the medical cause of a complex condition such as is here presented requires expert evidence”), aff’d mem., 860 A.2d 1142 (Pa. Super. 2004).

Puerto Rico

The law in Puerto Rico holds that “a factfinder normally cannot find causation without the assistance of expert testimony to clarify complex medical and scientific issues that are more prevalent in medical malpractice cases than in standard negligence cases.”  Marcano Rivera v. Turabo Medical Center Partnership, 415 F.3d 162, 168 (1st Cir. 2005) (quoting Rojas-Ithier v. Sociedad Española de Auxilio Mutuo y Beneficiencia, 394 F.3d 40, 43 (1st Cir. 2005)) (applying Puerto Rico law).  “[T]he 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.”  Collazo-Santiago v. Toyota Motor Corp., 937 F. Supp. 134, 140 (D.P.R. 1996) (citation and quotation marks omitted), aff’d, 149 F.3d 23 (1st Cir. 1998).  See Velazquez v. Abbott Laboratories, 901 F. Supp.2d 279, 293 (D.P.R. 2012) (entering summary judgment on product liability claims because “plaintiffs have failed to introduce any expert testimony . . . to support their claims”).

The same rule applies to prescription medical products.  “[D]etermining when or if a given medication caused injuries when it was prescribed is the typical complex medical and scientific issue that . . . requires the assistance of a medical or scientific expert.”  Mercado-Velilla v. Asociacion Hospital del Maestro, 902 F. Supp.2d 217, 239 (D.P.R. 2012) (citation and quotation marks omitted).  See In re Bausch & Lomb Inc. Contacts Lens Solution Products Liability Litigation, 693 F. Supp.2d 515, 520 (D.S.C. 2010) (“this case involves complex medical causation questions . . . that are outside the realm of ‘common experience.’  Therefore, expert testimony is required under Puerto Rico law.”), aff’d, 429 F. Appx. 249 (4th Cir. 2011) (applying Puerto Rico law).

Rhode Island

Rhode Island precedent “is well settled that expert testimony is required to establish any matter that is not obvious to a lay person and thus lies beyond common knowledge.”  Rhode Island Resource. Recovery Corp. v. Restivo Monacelli LLP, 189 A.3d 539, 547 (R.I. 2018) (quoting Jessup & Conroy, P.C. v. Seguin, 46 A.3d 835, 839 (R.I. 2012)).  See Almonte v. Kurl, 46 A.3d 1, 18 (R.I. 2012) (same).  “[M]atters concerning [diseases] and [drug] therapy are not so obvious that the need for expert testimony is obviated.”  Young v. Park, 417 A.2d 889, 893 (R.I. 1980).

Thus, in product liability cases, the “we do not hesitate to conclude that the existence of a causal relationship between a particular toxin and its effect on the human body would have to be established through expert testimony.”  Mills v. State Sales, Inc., 824 A.2d 461, 468 (R.I. 2003).  Even as to products that “average lay persons use . . . every day, . . . only an expert who understands the[ir] mechanics . . . could understand and explain the [product] and whether a defect proximately caused an injury.”  Olshansky v. Rehrig International, 872 A.2d 282, 287 (R.I. 2005) (abrogated on other grounds, Cruz v. DaimlerChrysler Motors Corp., 66 A.3d 446 (R.I. 2013)).  See Hartford Insurance Co. v. General Electric Co., 526 F. Supp.2d 250, 260 (D.R.I. 2007) (“In the absence of such expert evidence . . ., Plaintiffs have not otherwise identified competent evidence upon which a reasonable jury could find that the alleged defect in the [product] was the proximate cause”).

South Carolina

“The general rule in South Carolina is that where a subject is beyond the common knowledge of the jury, expert testimony is required.”  Babb v. Lee County Landfill SC, LLC, 747 S.E.2d 468, 481 (S.C. 2013).  “[W]hen the medical question is a complicated one and likely to carry the fact-finding body into realms which are more properly within the province of medical experts,” “the subject is one for experts or skilled witnesses alone.”  Herndon v. Morgan Mills, Inc., 143 S.E.2d 376, 384 (1965).  “If [a plaintiff] is attempting to establish causation of a medically complex condition, however, expert medical testimony is required.”  Smith v. Michelin Tire Co., 465 S.E.2d 96, 97 (S.C. App. 1995).

Likewise, in South Carolina product liability cases, “expert evidence is required where a factual issue must be resolved with scientific, technical, or any other specialized knowledge.”  Watson v. Ford Motor Co., 699 S.E.2d 169, 175 (S.C. 2010).

Whether expert testimony is required is a question of law.  We have little trouble concluding as a matter of law that the [plaintiffs’] claim is one such case because it involves complex issues of computer science. . . .  [T]the design and structure of the software . . . is beyond the ordinary understanding and experience of laymen.  Hence, [plaintiffs] must support their allegations with expert testimony, and without it, their claims are subject to dismissal.

Graves v. CAS Medical Systems, Inc., 735 S.E.2d 650, 659 (S.C. 2012) (citations omitted).  See Oglesby v. General Motors Corp., 190 F.3d 244, 251 (4th Cir. 1999) (“Without [expert] testimony, [plaintiff] failed to meet his burden of proof.”) (applying South Carolina law); Green v. Bradley Co., 2017 WL 4012298, at *7 (D.S.C. Sept. 12, 2017) (“Absent the now-excluded testimony of [her expert], Plaintiff is unable to establish either the existence of a defect in the [product] at issue, or that a defect was the proximate cause of her injury − both essential elements of her claim.”), aff’d, 771 F. Appx. 184 (4th Cir. 2019); Morris v. Dorma Automatics Inc., 2013 WL 212587, at *6 (D.S.C. Jan. 18, 2013) (summary judgment granted where plaintiff “did not offer expert testimony”), aff’d, 537 F. Appx. 254 (4th Cir. 2013); Hickerson v. Yamaha Motor Corp., U.S.A., 2016 WL 4367141, at *4 (D.S.C. Aug. 16, 2016) (“without such expert testimony here to support Plaintiff’s claims of inadequate warnings, it would be difficult for this court to accept that a jury could find that the warnings . . . inadequate”), aff’d, 882 F.3d 476 (4th Cir. 2018); Stewart v. AT & T Mobility LLC, 2011 WL 3626654, at *5 (Mag. D.S.C. July 21, 2011) (“Without such admissible expert testimony to support a plaintiff’s theory of causation, the defendant is entitled to summary judgment.”), adopted, 2011 WL 3626641 (D.S.C. Aug. 17, 2011); Owens v. Hertz Equipment Rental Corp., 2010 WL 11534370, at *2 (D.S.C. Dec. 23, 2010) (“the use, operation, and maintenance of the [product] are technical matters which go beyond the scope of a lay person’s knowledge.  Therefore, Plaintiff must bring forth expert testimony to establish his burden of proof.”); Morehouse v. Louisville Ladder Group LLC, 2004 WL 2431796, at *9 (D.S.C. June 28, 2004) (“In the absence of [expert] testimony, Plaintiff is unable to establish that Defendant’s [product] was defective or that such defect caused Plaintiff’s accident.”).

Specifically, “[u]nder South Carolina law, in a [prescription medical product liability] case where a medical causation issue is not one within the common knowledge of the layman, the plaintiff must present medical expert testimony in order to establish causation.  Jones v. American Cyanamid Co., 139 F.3d 890, 1998 WL 116171, at *3 (4th Cir. 1998) (citation and quotation marks omitted) (applying South Carolina law).  “To establish defect and unreasonable danger in a medically complex [product liability] case, plaintiff must come forward with relevant and reliable expert testimony on these issues.”  King v. Stryker Corp., 2012 WL 12981763, at *4 (D.S.C. April 3, 2012) (citation and quotation marks omitted).  “Where a medical causal relation issue is not one within the common knowledge of the layman, proximate cause cannot be determined without expert medical testimony.”  In re Bausch & Lomb Inc. Contacts Lens Solution Products Liability Litigation, 693 F. Supp.2d 515, 518 (D.S.C. 2010), aff’d, 429 F. Appx. 249 (4th Cir. 2011).

[A] plaintiff [who] has not come forward with any proposed expert to offer biomechanical testimony . . . has no means of establishing how any proposed, theoretical modifications to the design of the [device] would function once implanted in the human body.  Without testimony necessary to fill this evidentiary gap, plaintiff cannot, as a matter of law, establish that the [device] was defective or unreasonably dangerous.

Disher v. Synthes (U.S.A.), 371 F. Supp.2d 764, 770 (D.S.C. 2005).  “Expert testimony is required where the claimant is ‘attempting to establish causation of a medically complex condition.’”  Jones v. Danek Medical, Inc., , 1999 WL 1133272, at *4 (D.S.C. Oct. 12, 1999) (emphasis original) (quoting Smith v. Michelin).  See Phelan v. Synthes (U.S.A.), 35 F. Appx. 102, 108-10 (4th Cir. 2002) (affirming summary judgment and exclusion of plaintiff’s expert); McClure v. Wyeth, 2012 WL 952856, at *1 (D.S.C. March 20, 2012) (“Under South Carolina law, expert testimony is necessary to establish causation for cases involving a complex medical condition”) (citing Smith); Jones v. Danek Medical, Inc., 1999 WL 1133272, at *4–5 (D.S.C. Oct. 12., 1999) (“granting summary judgment” when plaintiff failed to produce qualified expert to show causation in defective medical device case).

South Dakota

In South Dakota, “expert testimony is required when the issue falls outside the common experience of a jury.”  Burley v. Kytec Innovative Sports Equipment, Inc., 737 N.W.2d 397, 407 (S.D. 2007) (citing Caldwell v. John Morrell & Co., 489 N.W.2d 353 (S.D. 1992)).  “[A]bsent expert testimony, there is no basis for the jury to evaluate the actions of an ordinary prudent person.”  Id. at 408-09 (citation omitted).

Medical opinion on causation of physical injury is unnecessary only if the cause and effect are so immediate, direct and natural to common experience as to obviate any need for an expert medical opinion.  On the other hand, when symptoms are more separated in time from the accident, the causal relationship becomes more tenuous, necessitating expert testimony to prove causation.

Hanson v. Big Stone Therapies, Inc., 916 N.W.2d 151, 162 (S.D. 2018) (citations and quotation marks omitted).

Further, “in attempting to establish the elements of products liability, . . . [e]xpert testimony is generally necessary to establish elements of negligence and strict liability.”  Nationwide Mutual Insurance Co. v. Barton Solvents, Inc., 855 N.W.2d 145, 151 (S.D. 2014) (citation omitted).  “Plaintiff bore the burden to prove both liability and causation in a products liability action and expert testimony was necessary to provide ‘an evidentiary basis’ to successfully resist summary judgment.”  Cooper v. Brownell, 923 N.W.2d 821, 825 (S.D. 2019) (quoting Barton Solvents).  See Lindholm v. BMW of North America, LLC, 202 F. Supp.3d 1082, 1094 (D.S.D. 2016) (“it is not patently obvious that the accident would not have happened in the absence of a defect, and thus expert testimony is necessary to support Plaintiffs’ claims”), aff’d, 862 F.3d 648 (8th Cir. 2017); O’Neal v. Remington Arms Co., L.L.C., 2016 WL 1465351, at *3 (D.S.D. April 14, 2016) (Whether a plaintiff’s theory is based on strict liability or negligence, expert testimony is generally necessary to establish that a product is defective and that the defect proximately caused the plaintiff’s injury.”); Donat v. Trek Bicycle Corp., 2016 WL 297436, at *5 (D.S.D. Jan. 22, 2016) (“expert testimony is required when there is a complicated causation issue in a products liability case”); Jensen v. Hy-Vee, Corp., 2011 WL 1832997, at *4, 9 (D.S.D. May 13, 2011) (“expert testimony is required to help the jury determine whether . . . the alleged design defect caused [plaintiff’s] injuries” (citing Burley); “expert testimony establishing a causal connection between the lack of warning and [plaintiff’s] injuries is needed”).


Tennessee precedent requires that “[m]edical causation and permanency of an injury must be established in most cases by expert medical testimony.”  Thomas v. Aetna Life & Casualty Co., 812 S.W.2d 278, 283 (Tenn. 1991) (citations omitted).  “Typically, causation is established through expert medical testimony.”  Conner Brothers Excavating Co. v. Long, 98 S.W.3d 656, 660 (Tenn. 2003) (citing Thomas).

[W]hen the cause of an injury is not within the common knowledge of lay persons, expert medical evidence . . . is required.  Where an injury is complex or closely related to a pre-existing condition, expert evidence is critically important.  In these circumstances, the fact-finder cannot make a rational determination regarding whether the [defendant’s actions] caused the injury.

Austin v. Sneed, 2007 WL 3375335, at *11 (Tenn. App. Nov. 13, 2007) (citations omitted).  See Jones v. Firestone Tire & Rubber, 2001 WL 432528, at *3 (Tenn. April 27, 2001) (holding, in an asbestos exposure case, that “in all but the most obvious cases . . ., expert testimony is required to establish causation.  Proof of causation in this case must be shown by expert testimony.”) (citing Thomas).

In product liability cases, “[m]odern case law requires expert medical testimony to establish causation in cases where the plaintiff has suffered a complex injury.”  Smith v. General Motors Corp., 376 F. Supp.2d 664, 667 (W.D. Va. 2005), aff’d, 179 F. Appx. 890 (4th Cir. 2006) (for reasons stated by trial court) (applying Tennessee law).  To “establish[] the unreasonable dangerousness of a complex product about which an ordinary consumer has no reasonable expectation . . ., [t]he plaintiff must offer expert testimony.”  Brown v. Raymond Corp., 432 F.3d 640, 644 (6th Cir. 2005) (citation and quotation marks omitted).  With respect to a complex product, “without admissible expert testimony on causation and product defect, no reasonable jury could find for [plaintiff] because, under Tennessee law, expert testimony is required to establish liability in cases alleging manufacturing and design defects.”  Pride v. BIC Corp., 218 F.3d 566, 580 (6th Cir. 2000) (applying Tennessee law).  “Under Tennessee law, a plaintiff must provide admissible expert testimony as to both causation and product defect in order to prove liability in a products action. . . .  Moreover, under Tennessee law, medical causation must be established by expert testimony.”  Tomazin v. Lincare, Inc., 2015 WL 4545658, at *12 (M.D. Tenn. July 27, 2015) (citations omitted).  Thus, “[i]t is settled law that plaintiffs in a toxic tort case must present competent expert testimony . . . that links the individual plaintiff’s harm to the toxic substance allegedly causing the plaintiff’s injury.”  Spencer v. Synair Corp., 2005 WL 1719904, at *6 (E.D. Tenn. July 22, 2005) (quoting Nelson v. Tennessee Gas Pipeline Co., 2002 WL 1397253, at *2 (W.D. Tenn. June 11, 2002)).  See Whaley v. Rheem Manufacturing Co., 900 S.W.2d 296, 301 (Tenn. App. 1995) (plaintiff required expert testimony to demonstrate defect because the “workings of [the product] are beyond the common knowledge of laymen.”); Johnson v. Manitowoc Boom Trucks, Inc., 484 F.3d 426, 429 (6th Cir. 2007) (“expert testimony about the prudence of the decision to market becomes essential to [the] plaintiff’s case in chief” “because it involves establishing the unreasonable dangerousness of a complex product”) (citation and quotation marks omitted) (applying Tennessee law); Downs v. Perstorp Components, Inc., 26 F. Appx. 472, 477 (6th Cir. 2002) (“without admissible expert testimony on causation, no reasonable jury could find for plaintiffs because Tennessee law requires proof of causation for both strict liability and negligence actions”) (applying Tennessee law); Sanford v. L’Oreal USA S/D, Inc., 2017 WL 2376922, at *2 (M.D. Tenn. June 1, 2017) (where plaintiff “has failed to submit any testimony from a medical expert . . . there exists no material factual dispute regarding the cause of” her injuries); Coffey v. Dowley Manufacturing, Inc., 187 F. Supp.2d 958, 972 (M.D. Tenn. 2002) (“Plaintiffs will be unable to make out a claim for products liability without the use of an expert.  This product is simply too complex and too unfamiliar to ordinary consumers.”), aff’d, 89 F. Appx. 927 (6th Cir. 2003).

Prescription medical products are “complex products” under Tennessee law, requiring expert testimony.  In Jastrebski v. Smith & Nephew Richards, Inc., 1999 WL 144935 (Tenn. App. March 18, 1999), the court held:

Plaintiff’s testimony cannot substitute for the expert testimony required to establish a causal connection between an alleged defect in the product and a specific injury.  The product in dispute is a technically complex prescription medical device, and expert testimony is required to establish the causal connection between the alleged defect in the device and Plaintiff’s claimed injuries.

Id. at *6.  Jastrebski cited Fulton v. Pfizer Hospital Products Group, Inc., 872 S.W.2d 908, 912 (Tenn. App. 1993), which rejected use of res ipsa loquitur, holding that, where “the product in dispute is a technically complex medical device . . . expert testimony is required.”  Id. at 912.  See King v. Danek Medical, Inc., 37 S.W.3d 429, 449, 450, 461 (Tenn. App. 2000) (affirming summary judgment after concluding that plaintiff’s experts “failed to establish” either that “the defendants’ devices were unreasonably dangerous” or any “defective condition of the [medical device] implanted into the plaintiffs or causation”); Ward v. Cook, Inc., 2015 WL 3556060, at *2 (S.D.W. Va. June 4, 2015) (“medical causation must be established by testimony from a medical expert”) (applying Tennessee law); Shannon v. Apria Healthcare, Inc., 2011 WL 873458, at *5 (M.D. Tenn. March 4, 2011) (medical device case; “[w]ithout expert medical proof . . ., the factual allegations made by Plaintiff . . . cannot be sustained as a matter of law”); In re Aredia & Zometa Products Liability Litigation, 2009 WL 8638121, at *1 (M.D. Tenn. Aug. 13, 2009) (“Whether the warnings were adequate to warn a physician of the possibility that the drug might be causing the condition experienced must be presented through the testimony of an expert.”) (citations omitted);


“The general rule” in Texas “has long been that expert testimony is necessary to establish causation as to medical conditions outside the common knowledge and experience of jurors.”  Guevara v. Ferrer, 247 S.W.3d 662, 665 (Tex. 2007).  “[W]hen the causal link is beyond the jury’s common understanding, expert testimony is necessary.”  Alexander v. Turtur & Associates., Inc., 146 S.W.3d 113, 119-20 (Tex. 2004).  “The determination whether expert testimony is necessary is . . . a question of law.”  FFE Transportation Services, Inc. v. Fulgham, 154 S.W.3d 84, 89 (Tex. 2004).  Summing up:

Expert testimony is required when an issue involves matters beyond jurors’ common understanding.  Proof other than expert testimony will support a jury finding only when the jurors’ common understanding and experience will allow them to make that finding with reasonable probability.  . . .  The plaintiffs’ causation theory in this case is complex . . . [and] [w]e therefore hold that the plaintiffs must have supported their causation theory with expert testimony and objective proof.

Gharda USA, Inc. v. Control Solutions, Inc., 464 S.W.3d 338, 348 (Tex. 2015) (citations and quotation marks omitted).  See Bright v. Simpson, 2019 WL 1941885, at *4 (Tex. App. April 30, 2019) (“Without expert medical testimony, the evidence is legally insufficient to support a finding that the collision caused all of [plaintiff’s] damages.”); Zamora v. Champion Cooler Corp., 2018 WL 507362, at *2 (Tex. App. Jan. 23, 2018) (“expert testimony is necessary to establish causation regarding medical conditions outside the common knowledge and experience of jurors”); Cerny v. Marathon Oil Corp., 480 S.W.3d 612, 620 (Tex. App. 2015) (“The requirement of expert testimony is equally obvious in this case where [plaintiffs’] claims arise out of the alleged emissions and migration of hazardous substances”); Oncor Electric Delivery Co., LLC v. Southern Foods Group, LLC, 444 S.W.3d 699, 705 (Tex. App. 2014) (“Expert testimony is required when an issue involves matters beyond jurors’ common understanding.”) (citing Tamez); Dickerson v. State Farm Lloyd’s Inc., 2011 WL 3334964, at *14 (Tex. App. Aug. 3, 2011) (affirming both expert exclusions and summary judgment); Plunkett v. Connecticut General Life Insurance Co., 285 S.W.3d 106, 121 (Tex. App. 2009) (affirming summary judgment in toxic exposure case after affirming exclusion of plaintiffs’ experts); Brookshire Brothers, Inc. v. Smith, 176 S.W.3d 30, 36 (Tex. App. 2004) (“When a lay person’s general experience and common sense will not enable that person to determine causation, expert testimony is required.”); Feria v. Dynagraphics Co., 2004 WL 500869, at *9 (Tex. App. March 15, 2004) (“Because we find that the court did not abuse his discretion in excluding the expert witnesses tendered by [plaintiff], there was no evidence of causation presented to the court to defeat the defendants’ motions for summary judgment.”); Smith v. Southwest Bell Telephone Co., 101 S.W.3d 698, 702 (Tex. App. 2003) (“Proof that an injury to a specific body part extends to and affects the body generally must be supported by expert medical testimony and is not within the general experience of the jury.”).

Likewise, “[w]e have consistently required expert testimony and objective proof to support a jury finding that a product defect caused the plaintiff’s condition.”  Gharda, 464 S.W.3d at 348 (citations and quotation marks omitted).  In product liability cases, “[w]hether expert testimony is required depends on whether the issue involves matters beyond the general experience and common understanding of laypersons.”  Mack Trucks, Inc. v. Tamez, 206 S.W.3d 572, 583 (Tex. 2006).  “If juries were generally free to infer a product defect and injury causation from an accident or product failure alone, without any proof of the specific deviation from design that caused the accident, expert testimony would hardly seem essential.  Yet we have repeatedly said otherwise.”  Ford Motor Co. v. Ledesma, 242 S.W.3d 32, 42-43 (Tex. 2007) (citations omitted).  Texas law has “consistently required competent expert testimony and objective proof that a defect caused the [accident].”  Nissan Motor Co. Ltd. v. Armstrong, 145 S.W.3d 131, 137 (Tex. 2004).  Thus, “expert testimony is crucial in establishing that the alleged design defect caused the injury.”  Sims v. Kia Motors, Inc., 839 F.3d 393, 409 (5th Cir. 2016) (footnote omitted) (applying Texas law).

This case illustrates the type of complex causation theory that requires expert testimony and objective proof. . . .  Without such an expert, the plaintiffs have not met their burden of production under Texas law.  The plaintiffs’ failure to produce a fire expert who can identify the cause of the fire is therefore fatal to their success.

Smith v. Chrysler Group, L.L.C., 909 F.3d 744, 751-52 (5th Cir. 2018) (citations and footnotes omitted) (applying Texas law).  See BIC Pen Corp. v. Carter, 346 S.W.3d 533, 542 (Tex. 2011) (“Expert testimony is generally required in manufacturing defect cases to prove that the specific defect caused the accident.”); PHI, Inc. v. LeBlanc, 2016 WL 747930, at *8 (Tex. App. Feb. 25, 2016) (“whether [the product’s] design was defective involves a matter beyond the jurors’ common understanding, [so] we conclude that as a matter of law expert testimony was required”); Starr v. A.J. Struss & Co., 2015 WL 4139028, at *6 (Tex. App. July 9, 2015) (“Expert testimony is particularly necessary in toxic-tort and chemical-exposure cases, in which medically complex diseases and causal ambiguities compound the need for expert testimony.”) (citations omitted); iLight Technologies, Inc. v. Clutch City Sports & Entertainment, L.P., 414 S.W.3d 842, 851 (Tex. App. 2013) (“Expert testimony is generally required in manufacturing defect cases to prove that the specific defect caused the accident.”); Mata v. Energy Absorption Systems, LLC, 2011 WL 1233584, at *4 (Tex. App. March 31, 2011) (“competent expert testimony and objective proof that a defect caused the harm is required”); Lyon v. ATICO International USA, Inc., 2009 WL 1800820, at *2 (Tex. App. June 24, 2009) (“causation is not within a layperson’s general experience and common understanding; thus, expert testimony was required to establish a manufacturing defect”); Driskill v. Ford Motor Co., 269 S.W.3d 199, 205 (Tex. App. 2008) (“Because [plaintiffs] presented no expert testimony on causation . . ., there is less than a scintilla of evidence that the [product] was the cause-in-fact of the [incident] in this case.”); Poteet v. Kaiser, 2007 WL 4371359, at *3 (Tex. App. Dec. 13, 2007) (“a determination of causation in this case requires expert testimony”); Brown v. Rreef Management Co., 2007 WL 1829725, at *1 (Tex. App. June 27, 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 omitted); Hair v. Church & Dwight Co., 2004 WL 1615833, at *2 (Tex. App. July 20, 2004) (“Because [plaintiff] did not direct the trial court to any expert testimony that [defendant’s] product caused his injury, he did not raise a fact question on proximate cause.”); Sweeney v. Geon Co., 2002 WL 58223, at *4 (Tex. App. Jan. 17, 2002) (affirming summary judgment; “proving causation [here] requires expert testimony” because “causation of injuries from exposure to toxic chemicals is not readily ascertainable from general experience and common sense”); City of Dallas v. Furgason, 2007 WL 2703134, at *2 (Tex. App. Sept. 18, 2007) (“the record does not contain any expert testimony regarding either general or specific causation.  Thus, we conclude the evidence is legally insufficient to show the causal connection”); Norman v. Grove Cranes U.S., L.L.C., 750 F. Appx. 269, 273 (5th Cir. 2018) (“numerous intermediate Texas courts and federal district courts have granted judgments in favor of defendants where no admissible expert testimony was offered to prove the existence of a safer alternative design”) (citations omitted) (applying Texas law); Velasquez v. EAN Holdings, LLC, 2018 WL 5924037, at *9 (N.D. Tex. Nov. 13, 2018) (“Without expert testimony, Plaintiff has provided no evidence supporting his claim that the alleged condition of the [product], . . . proximately caused his injury.”); Carter v. Southstar Management, LLC, 2018 WL 5281791, at *5 (S.D. Tex. Oct. 24, 2018) (summary judgment granted “[b]ecause toxic tort cases require expert evidence of both general and specific causation, and there is no expert evidence on causation”); Deeds v. Whirlpool Corp., 2017 WL 3437772, at *13 (S.D. Tex. Aug. 10, 2017) (“Plaintiffs must have an expert witness for the defective product claims.”), aff’d, 764 F. Appx. 407 (5th Cir. 2019); Samuell v. Toyota Motor Corp., 2015 WL 1925902, at *5 (W.D. Tex. April 27, 2015) (“expert testimony is essential to both the existence of the defect and to its causation of injury”); Sedgwick v. BP Products North America, Inc., 2014 WL 6911543, at *3 (S.D. Tex. Nov. 4, 2014) (“Plaintiff’s claim is beyond the general experience of laypersons, and therefore requires expert testimony to establish both general and specific causation.”) (citation omitted); Romo v. Ford Motor Co., 798 F. Supp.2d 798, 809 (S.D. Tex. 2011) (“Courts applying Texas law in products liability actions have frequently required expert testimony for both defect and causation.”); In re Ford Motor Co. Speed Control Deactivation Switch Products Liability Litigation, 2011 WL 2518776, at *3 (E.D. Mich. March 29, 2011) (plaintiff’s expert’s “testimony is stricken, [and] Plaintiff does not have any evidence to support her burden of proving that a defective [product] caused the [incident]”) (applying Texas law); Kallassy v. Cirrus Design Corp., 2006 WL 1489248, at *4 (N.D. Tex. May 30, 2006) (“Without expert testimony, [plaintiff] cannot prove the existence of defect, an element essential to his strict product liability claims.”), aff’d, 265 F. Appx. 165 (5th Cir. 2008); Sigurdson v. Ford Motor Co., 2006 WL 417502, at *3 (S.D. Tex. Feb. 21, 2006) (“In light of the complete absence of expert testimony . . ., Defendant is entitled to summary judgment.”); Robinson v. Proctor & Gamble Distributing Co., 2004 WL 3019092, at *2 (N.D. Tex. Dec. 30, 2004) (“Because this Court struck Plaintiff’s expert on causation, she is left without any expert testimony”; “to the extent Plaintiff seeks damages for her [condition], she will be barred from recovery”).

In particular, “expert testimony is needed to satisfy the reasonable medical probability standard for establishing a causal link” in Texas prescription medical product cases.  Anderson v. Siemens Corp., 335 F.3d 466, 475 (5th Cir. 2003) (applying Texas law).  “Evidence of general causation in a drug case must be established through expert testimony.”  Wells v. SmithKline Beecham Corp., 2009 WL 564303, at *5 (W.D. Tex. Feb. 18, 2009), aff’d, 601 F.3d 375 (5th Cir. 2010).  “Texas courts have regarded expert testimony on causation as particularly vital in cases involving complex medical devices and medical diagnoses.”  Lewis v. Johnson & Johnson, 601 F. Appx. 205, 211 (4th Cir. 2015) (applying Texas law).

[E]xpert testimony is necessary to establish that Defendant’s alleged negligence in designing, assembling, inspecting, and maintaining the [medical device] (as well as failing to warn Plaintiff) proximately caused Plaintiff’s injuries.  Therefore, Plaintiff cannot escape his burden of offering expert testimony to support his causation theory merely by pleading that this is a case of simple negligence, rather than strict products liability.  In sum, Plaintiff’s failure to designate an expert to testify concerning proximate causation of his injuries is fatal to his case.

Morris v. National Seating & Mobility, Inc., 2019 WL 2343020, at *5 (Mag.W.D. Tex. June 3, 2019) (citations omitted).  See Burroughs Wellcome Co. v. Crye, 907 S.W.2d 497, 499-500 (Tex. 1995) (reversing verdict after excluding plaintiff’s expert); Johnson & Johnson v. Batiste, 2015 WL 6751063, at *4 (Tex. App. Nov. 5, 2015) (“proving the existence of a design defect requires competent expert testimony and objective proof that the defect the plaintiff has identified caused the injury”); Schronk v. Laerdal Medical Corp., 440 S.W.3d 250, 265 (Tex. App. 2013) (given “that the trial court did not err in excluding the testimony of [plaintiff’s experts], we cannot conclude that the trial court erred in granting summary judgment” to medical device manufacturer); Ethicon Endo-Surgery, Inc. v. Gillies, 343 S.W.3d 205, 212 (Tex. App. 2011) (since “the standard of care in marketing a specialized medical device requiring specialized technique for use is not within the experience of laymen, we must also conclude expert testimony was required to prove negligent marketing of such a device”); Minnesota Mining & Manufacturing Co. v. Atterbury, 978 S.W.2d 183, 203 (Tex. App. 1998) (“the plaintiffs’ experts failed to offer any reliable evidence of general causation” and “[i]n the absence of such evidence, the award of actual damages to the plaintiffs must therefore be reversed.”); Emerson v. Johnson & Johnson, 2019 WL 764660, at *3 (S.D. Tex. Jan. 22, 2019) (medical device “allegations involve complex and technical medical issues beyond jurors’ common understanding, knowledge, and experience, and therefore expert testimony on causation is required”); Tsao v. Ferring Pharmaceuticals, Inc., 2018 WL 3589097, at *7 (Mag. S.D. Tex. April 17, 2018) (“the nature, function, and potency of [a drug] . . . and its impact on [a] medically complicated process . . . are beyond the common knowledge and experience of laypersons”), adopted, 2018 WL 3589082 (S.D. Tex. June 13, 2018); Samuel v. Johnson & Johnson, 2015 WL 10793724, at *4 (E.D. Tex. Aug. 14, 2015) (expert testimony required to prove causation because “the nature and function of the prescription drug . . .  are outside the common understanding of a layperson.”); Christian v. Cook Inc., 2015 WL 3557242, at *2 (S.D.W. Va. June 4, 2015) (“the plaintiffs here must offer a medical expert . . . to testify on causation”) (citing Guevara) (applying Texas law); Gutierrez v. Arrow International, Inc., 2011 WL 13324082, at *9 (W.D. Tex. May 17, 2011) (“Absent expert testimony, [plaintiff] cannot raise a genuine issue of material fact that [the device] manufactured by the . . . defendants . . . caused or could cause him harm”); Wells v. SmithKline Beecham Corp., 2009 WL 564303, at *5 (W.D. Tex. Feb. 18, 2009) (“Evidence of general causation in a drug case must be established through expert testimony.”), aff’d, 601 F.3d 375 (5th Cir. 2010); Hohmann v. Shire Pharmaceuticals, 2008 WL 11388683, at *3 (S.D. Tex. July 3, 2008) (“Plaintiffs are required to produce expert testimony to satisfy the element of causation common to all of their claims”); In re Diet Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Products Liability Litigation, 2008 WL 355517, at *2 (E.D. Pa. Feb. 8, 2008) (“Expert testimony regarding causation is therefore required”; without an expert, “Plaintiff has put forth no evidence that her alleged injury was caused by [defendant]s’ diet drugs”) (applying Texas law); Snee v. Zimmer, Inc., 2005 WL 8161446, at *2 (E.D. Tex. Sept. 16, 2005) (medical device case involves “complex issues of causation, undoubtedly requiring expert testimony and scientific analysis”); Kimble v. Danek Medical, Inc., 2000 WL 1468675, at *3 (S.D. Tex. Sept. 7, 2000) (“the effect of the implantation of a [medical] device . . . is not a matter of common knowledge or within the experience of a layperson” so “expert testimony is required on the issues of medical causation”) (citation and quotation marks omitted); Nobles v. Sofamor, S.N.C., 81 F. Supp.2d 735, 740 (S.D. Tex. 1999) (with plaintiff’s expert excluded, there is“no fact issue as to the presence of an instrument defect that caused [plaintiff’s] injury.”); Conger v. Danek Medical, Inc., 1998 WL 1041331, at *7 (N.D. Tex. Dec. 14, 1998) (exclusion of plaintiff’s experts means “Plaintiffs have not raised a genuine fact issue as to causation”); Leigh v. Danek Medical, Inc., 1998 WL 1041329, at *6 (N.D. Tex. Dec. 14, 1998) (with plaintiff’s experts excluded, “it is clear that plaintiff cannot raise a genuine issue of material fact as to causation”); Kelley v. American Heyer-Schulte Corp., 957 F. Supp. 873, 884 (W.D. Tex. 1997)  (“Due to . . . exclusion of expert testimony, the Plaintiff can present no evidence that [defendants’ devices] cause” the alleged injuries).


Utah law requires expert testimony on “scientific matters beyond the capacity of an ordinary juror.”  Graves v. North. Eastern. Services, Inc., 345 P.3d 619, 627 (Utah 2015).

[Where] the standard of care and the causal link between the negligence and the injury are usually not within the common knowledge of the lay juror, testimony from relevant experts is generally required in order to ensure that factfinders have adequate knowledge upon which to base their decisions.

Bowman v. Kalm, 179 P.3d 754, 755–56 (Utah 2008) (citation omitted).  “This is because the average lay juror is ill-equipped to sift through complicated medical evidence.”  Harris v. ShopKo Stores, Inc., 308 P.3d 449, 459 (Utah 2013).

In any type of case, “[i]n the absence of expert assistance, jurors would not likely possess the information or understanding necessary to make such assessments” involving “nuanced analysis of matters beyond the normal experience of the average layperson.”  Jenkins v. Jordan Valley Water Conservancy Dist., 321 P.3d 1049, 1053-54 (Utah 2013).  “[W]here the injury involves obscure medical factors which are beyond an ordinary lay person’s knowledge, necessitating speculation in making a finding, there must be expert testimony that the negligent act probably caused the injury.”  Fox v. Brigham Young University, 176 P.3d 446, 451–52 (Utah App. 2011) (citations and quotation marks omitted).  Moreover, “[i]t is only in the most obvious cases that a plaintiff may be excepted from the requirement of using expert testimony to prove causation.”  Id. (citation and quotation marks omitted).  See Hoopiiaina v. Intermountain Health Care, 740 P.2d 270, 271-72 (Utah App. 1987) (“In the absence of an expert to testify for plaintiff that the [drug] harmed him, . . . the jury would have no evidence upon which to base a finding that the [the drug] caused any harm to plaintiff.”); Pace v. Swerdlow, 519 F.3d 1067, 1073 (10th Cir. 2008) (“Because of the complex issues involved in a determination of proximate cause . . . Plaintiffs had to provide expert testimony.”) (citation and quotation marks omitted) (applying Utah law).

The same principles apply in Utah product liability and toxic tort cases.  “This court has held that medical expert testimony is required to prove proximate cause in a medical injury case.”  Fitz v. Synthes (USA), 990 P.2d 391, 393 (Utah 1999) (citation omitted).  In Fitz:

[Plaintiff] did not present any evidence supporting his medical causation claim, and the trial court would not allow his medical engineering expert to give an opinion on medical causation. . . .  In light of the foregoing, we conclude that . . . [plaintiff] failed to present evidence of medical causation.

Id. at 394.  In Reeves v. Geigy Pharmaceutical, Inc., “[t]he factual element underlying all [plaintiff’s] pleaded theories of liability is that his severe skin injuries were caused by [certain] drugs.”  764 P.2d 636, 640 (Utah App. 1988).  “Because these matters are outside the knowledge and experience of laypeople, expert medical testimony was required to establish causation, the standard of care, and its breach.”  Id.

Likewise, in warning cases, expert testimony is necessary because “[a] lay jury is not able to call on ‘their own life experiences’ to determine the adequacy of a drug label.”  Christison v. Biogen Idec, Inc., 199 F. Supp.3d 1315, 1340 (D. Utah 2016).  See King v. Searle Pharmaceuticals, Inc., 832 P.2d 858, 864 (Utah 1992) (“it cannot be concluded that an inference of [defendant’s] liability can be deduced from common experience and knowledge.  Accordingly, res ipsa loquitur is not sufficient to create a factual issue as to causation.”); Smith v. Terumo Cardiovascular Systems Corp., 2017 WL 2985749, at *4 (D. Utah July 12, 2017) (medical device case; “[m]edical causation (both but-for and proximate) must come from expert testimony (footnote omitted); Shipley v. Forest Laboratories, Inc., 2015 WL 4199739, at *4 (D. Utah July 13, 2015) (“In prescription drug cases, the causation element requires proof, usually in the form of expert testimony, of both general and specific causation.”) (citation omitted); Boucher v. Zimmer, Inc., 2010 WL 3815706, at *3 (D. Utah Sept. 27, 2010) (“because any testimony on the design of the [medical device] will present technically complex issues that are outside of the realm of jurors’ ordinary experience, Plaintiffs must offer admissible expert testimony in order to establish a design defect”); Coburn v. Smithkline Beecham Corp., 174 F. Supp.2d 1235, 1239 (D. Utah 2001) (“unclear . . . how Plaintiffs will establish that [a drug] was a cause of [plaintiff’s injuries] without eliciting expert testimony concerning general causation”).


Under Vermont law, “expert testimony is ordinarily required to prove medical causation.”  Sweet v. St. Pierre, 201 A.3d 978, 987-88 (Vt. 2018) (citation omitted).  “When the facts to be proved are such that any layman of average intelligence would know from his own knowledge and experience that the accident was the cause of the injury, no expert testimony is needed to establish the causal connection; however, where the causal connection is obscure, expert testimony is required.”  Egbert v. Book Press, 477 A.2d 968, 969 (Vt. 1984).  Where failure of an implanted medical device was at issue, “fault and causation are sufficiently complex as to be beyond the scope of common knowledge to a layperson”, so “that expert testimony was required to prove that theory.”  Taylor v. Fletcher Allen Health Care, 60 A.3d 646, 649-50 (Vt. 2012).  “While it is possible that the failure of the apparatus was a direct and proximate result of plaintiff’s fall, there is no way for a jury to intelligently evaluate the evidence without expert testimony.”  Id. at 651.

The same considerations apply to Vermont product liability and toxic tort litigation.  In Blanchard v. Goodyear Tire & Rubber, 30 A.3d at 1271 (Vt. 2011), a toxic tort case, summary judgment was appropriate where “[n]othing in [plaintiff’s expert’s] testimony was sufficient to support a jury finding of specific causation.”  Id. at 1278.  Thus, another Vermont court held:

[P]laintiffs in toxic exposure cases must demonstrate specific causation by submitting evidence concerning the amount, duration, intensity, and frequency of exposure.  In the absence of expert testimony, [plaintiffs] cannot establish these essential elements of their claims.

Dakers v. Bartow, 2018 WL 8415310, at *7 (D. Vt. Sept. 10, 2018) (Blanchard citation omitted).  In a drug case:

Plaintiffs must meet their burden of proving that ingestion of [the drug] caused the [injuries] in this case by offering expert testimony.  That expert testimony has been ruled inadmissible under Daubert.  Without expert testimony . . ., it is not possible to show that any inadequacy in warning about [the drug] was a substantial factor in bringing about the [those injuries].

Blanchard v. Eli Lilly & Co., 207 F. Supp.2d 308, 322 (D. Vt. 2002), see id. at 314 (“expert testimony is required to establish causation in this case”) (citations omitted).


“[E]xpert testimony is required” in Virginia to address any “complicated medical question that is not within the understanding of a lay person.”  Summers v. Syptak, 801 S.E.2d 422, 426 (2017).

Inasmuch as the causes of the injuries . . . are determinable only in the light of scientific knowledge, it has been recognized that expert testimony is usually necessary to support the conclusion as to causation.  The only exception to this requirement of expert testimony is the unusual case where the negligence and harmful results are sufficiently obvious as to lie within common knowledge.

Fitzgerald v. Manning, 679 F.2d 341, 350 (4th Cir. 1982) (citations and quotation marks omitted) (applying Virginia law).  See Williams v. Lowe’s Home Centers, Inc., 2018 WL 4699501, at *2 (Va. App. Oct. 2, 2018) (“when medical issues are complex, as in this case, causation must be determined by a medical expert”); Precision Pipeline, LLC v. Dominion Transmission, Inc., 2018 WL 3744018, at *3 (E.D. Va. Aug. 7, 2018) (“Without any expert testimony on the subject, [cross-plaintiff] cannot ask a lay jury to determine the complicated issue of causation.”); Clark v. Cobb, 2006 WL 6198463, at *4 (E.D. Va. Oct. 20, 2006) (“Plaintiff cannot establish the element of causation, an essential element of his negligence claim, without expert testimony”).

Virginia enforces the same requirements in toxic tort and product liability litigation.  “To prove causation in a toxic tort action, a plaintiff must offer relevant and reliable expert testimony, as the health effects of toxic exposure to chemicals are beyond the knowledge and experience of the average layperson.”  Zellers v. NexTech Northeast, LLC, 533 F. Appx. 192, 200 (4th Cir. 2013) (applying Virginia law).  Zellers affirmed the district court’s holding:

[I]n toxic tort cases, relevant and reliable expert testimony is required to prove (1) “that a particular chemical is harmful to humans generally,” i.e., general causation, and (2) “that exposure to the potentially harmful agent actually caused [the plaintiff’s injury],” i.e., specific causation.

Zellars v. NexTech Northeast, LLC, 895 F. Supp.2d 734, 739 (E.D. Va. 2012).

“Expert testimony is generally necessary to prove proximate causation in a products liability case.”  Schmitt-Doss v. American Regent, Inc., 2014 WL 3853184, at *8 (W.D. Va. Aug. 5, 2014), aff’d, 599 F. Appx. 71 (4th Cir. 2015) (for reasons stated by district court).  “[I]n a products liability action, proof of causation must ordinarily be supported by expert testimony because of the complexity of the causation facts.”  Kennedy v. Joy Technologies, Inc., 455 F. Supp.2d 522, 525 (W.D. Va. 2006), aff’d in pertinent part, 269 F. Appx. 302 (4th Cir. 2008) (applying Virginia law).  See Sanyal v. Toyota Motor North America, Inc., 2015 WL 3650725, at *7 (E.D. Va. June 11, 2015) (identical language); Cavallo v. Star Enterprise, 892 F. Supp. 756, 774 (E.D. Va. 1995) (“expert testimony is required to prove that exposure to a toxic substance caused a certain injury or illness”) (footnote omitted), aff’d in pertinent part, 100 F.3d 1150 (4th Cir. 1996).

For that proposition, both Kennedy and Sanyal quoted a prescription drug case, McCauley v. Purdue Pharma L.P., 331 F. Supp.2d 449, 464 (W.D. Va. 2004), demonstrating that expert testimony is required in prescription medical product liability litigation.  See Ball v. Takeda Pharmaceuticals America, Inc., 963 F. Supp.2d 497, 508, 510 (E.D. Va. 2013) (“plaintiff faces a fatal problem: she has no expert witness”; “[s]he must have expert testimony to meet her burden of proof”); Boysaw v. Purdue Pharma, 2008 WL 4452650, at *4 (W.D. Va. Sept. 30, 2008) (also quoting McCauley), aff’d, 320 F. Appx. 178 (4th Cir. 2009) (for reasons stated by district court); Evans v. Mentor Corp., 2005 WL 1667661, at *1 (E.D. Va. June 28, 2005) (also quoting McCauley); Hartwell v. Danek Medical, Inc., 47 F. Supp.2d 703, 707 (W.D. Va. 1999) (“[p]roof of legal causation in a medical device case must be by expert testimony”).

Virgin Islands

Virgin Islands law also follows “the general requirement of expert testimony on causation in a complex, toxic tort case.”  Henry v. St. Croix Alumina, LLC, 572 F. Appx. 114, 120 (3d Cir. 2014) (applying Virgin Islands law).  “[A] plaintiff is required to supply expert testimony in order to survive summary judgment on a design defect claim.”  Anders v. Puerto Rican Cars, Inc., 409 F. Appx. 539, 542-43 (3d Cir. 2011) (applying Virgin Islands law).  As the District Court explained in Anders:

[P]roving the existence of a defect in a product requires testimony from a qualified expert.  Where the issue concerns a product’s design, it would seem that expert opinion is the only available method to establish defectiveness, at least where the design is not patently defective.  Proving that an alleged defect was the legal cause of an injury requires testimony from a qualified expert who can testify about specific causation. . . .  Expert testimony offered by a competent expert who has an analytical and factual basis for his opinions should be required of plaintiffs in an automotive products liability case.

Anders v. Puerto Rican Cars, Inc., 2009 WL 3007367, at *9 (D.V.I. Sept. 15, 2009) (citations and quotation marks omitted), aff’d, 409 F. Appx. 539 (3d Cir. 2011).  See Washington v. HOVENSA, LLC, 2011 WL 6965855, at *1 (D.V.I. Dec. 13, 2011) (“[E]xpert testimony is required to prove causation in cases where the complexities of the human body place questions as to the cause of pain or injury beyond the knowledge of the average layperson.”) (internal quotations omitted).

Virgin Islands law follows the same principles in prescription medical product liability litigation:

Plaintiff’s case requires expert testimony to satisfy her burden with respect to both general causation and specific causation. In this case, “general causation” addresses the question of whether the ingredients of [drug] products are capable of causing [the relevant injury] in humans at therapeutic dose levels, while “specific causation” addresses whether those ingredients actually did cause [plaintiff’s injury].  If plaintiff’s expert opinion evidence regarding causation is inadmissible or insufficient to sustain a jury verdict in her favor, summary judgment is required to be granted to defendant.

Wade-Greaux v. Whitehall Laboratories, Inc., 874 F. Supp. 1441, 1475 (D.V.I. 1994) (citations omitted), aff’d mem, 46 F.3d 1120 (3d Cir. 1994).


Washington law holds that, when “[m]ust a patient present an expert medical opinion,” is a question “of law.”  Bauer v. White, 976 P.2d 664, 666 (Wash. App. 1999).

In general, expert testimony is required when an essential element in the case is best established by an opinion which is beyond the expertise of a layperson.  Expert testimony will generally be necessary to establish . . . most elements of causation. . . .  Medical facts must be proved by expert testimony unless they are observable by laypersons and describable without medical training.

Berger v. Sonneland, 26 P.3d 257, 267 (Wash. 2001) (footnotes omitted).  “Where the injury involves obscure medical factors which are beyond an ordinary lay person’s knowledge, necessitating speculation in making a finding, there must be expert testimony that the negligent act probably caused the injury.”  Riggins v. Bechtel Power Corp., 722 P.2d 819, 824 (Wash. App. 1986).  See Nikolayev v. Oyler, 143 Wash. App. 1012, 2008 WL 458649, at *2 (Wash. App. Feb. 21, 2008) (“The plaintiff must prove the causal relationship between the accident and his injuries.  And that requires expert testimony.”) (citation omitted); Cox v. Keg Restaurants U.S., Inc., 935 P.2d 1377, 1380 (Wash. App. 1997) (“Submitting the issue to the jury without such [expert] testimony is improper because the jury is thus invited to reach a result based on speculation and conjecture.”); Schudel v. General Electric Co., 35 F. Appx. 481, 484 (9th Cir. 2002). (“Because [plaintiff’s] injuries involved obscure medical factors and laypeople could not determine the injuries’ cause without resorting to speculation or conjecture, expert testimony was required to establish causation.”) (citation omitted) (applying Washington law); Bradley v. Wal-Mart Stores, Inc., 544 F. Supp.2d 1167, 1171 (W.D. Wash. 2008) (“A plaintiff must present medical testimony to establish the causal link between the injury and the incident.”).

The same is true in product liability.  “Expert testimony is required to establish causation when an injury involves obscure medical factors that would require an ordinary lay person to speculate or conjecture in making a finding.”  Bruns v. PACCAR, Inc., 890 P.2d 469, 477 (Wash. App. 1995).  See Koehler v. Allstate Insurance Co., 163 Wash. App. 1002, 2011 WL 3433304, at *7 (Wash. App. 2011) (“In the absence of any expert testimony supporting [plaintiff’s] allegations against [the product], the trial court properly granted summary judgment.”); McPhee v. Ford Motor Co., 135 Wash. App. 1017, 2006 WL 2988891, at *4 (Wash. App. Oct. 16, 2006) (summary judgment affirmed where plaintiff failed “to produce an affidavit from a qualified expert witness alleging specific facts that support a medical causation opinion”); Newkirk v. ConAgra Foods, Inc., 727 F. Supp.2d 1006, 1034 (E.D. Wash. 2010) (“in light of the exclusion of Plaintiffs’ [expert] evidence, Plaintiffs have failed to provide sufficient admissible evidence to support their burden of proof on any of their claims”), aff’d, 438 F. Appx. 607, 609 (9th Cir. 2011) (“Without the proffered expert testimony, [plaintiff] cannot show that [defendants] caused his disease.”); Henricksen v. ConocoPhillips Co., 605 F. Supp.2d 1142, 1177 (E.D. Wash. 2009) (“General causation and specific causation are essential elements of Plaintiffs’ prima facie case for each claim asserted in this litigation.  Expert testimony is necessary to make this showing since this is a toxic tort lawsuit.”) (citation omitted); Whisnant v. United States, 2006 WL 8442606, at *2 (W.D. Wash. Oct. 24, 2006) (“Fatal to plaintiffs’ case is the lack of expert testimony demonstrating the contaminants involved are capable of causing the specific ailments from which [she] suffers.”).

In cases involving use of prescription medical products, a plaintiff “ha[s] the burden of presenting expert medical testimony to demonstrate a causal link between the drug dose and the harmful effect.”  Smith v. Multicare Health System, 162 Wash. App. 1024, 2011 WL 2437797, at *2 (Wash. App. June 20, 2011).

[Plaintiff] must employ expert testimony if establishing this element would involve obscure medical facts requiring a lay person to speculate. . . .  [S]he must therefore present expert testimony assisting the jury in determining [the drug’s] impact on her and isolating it as a cause of her [injury]. . . .  Without this expert testimony, she cannot support a prima facie product liability action.

Sams v. Johnson & Johnson, 2015 WL 8213228, at *2 (W.D. Wash. Dec. 8, 2015) (citations omitted).

West Virginia

In West Virginia, “in a product liability case, the expert witness is ordinarily the critical witness.”  Morningstar v. Black & Decker Manufacturing Co., 253 S.E.2d 666, 682 (W.Va. 1979).  West Virginia law requires resort to expert testimony “where the injury is obscure, that is, the effects of which are not readily ascertainable, demonstrable or subject of common knowledge.”  Strahin v. Cleavenger, 603 S.E.2d 197, 211 (W. Va. 2004).

[W]here the exact nature and probable genesis of a particular type of injury involves complicated medical questions far removed from the ordinary experience and knowledge of laymen, only an expert can give competent opinion evidence as to the cause of the injury.

Turner v. Speedway LLC, 2015 WL 4392398, at *8 (S.D.W. Va. July 15, 2015) (citation and quotation marks omitted).

West Virginia “precedent reflects that expert testimony will be necessary to sustain an evidentiary burden when the matters involved are beyond the common knowledge and experience of the average juror.”  J.C. v. Pfizer, Inc., 814 S.E.2d 234, 243 (W. Va. 2018).  J.C., a prescription medical product liability case, held that expert testimony was critical to any evaluation of FDA-approved drug labeling.

[E]xpert testimony is necessary to sustain the burden of proof in complex cases involving matters of science, medicine, engineering, technology and the like. . . .  When the issues are beyond the common knowledge and experience of the average juror, expert testimony shall be required. . . .

[P]rescription drugs are likely to be complex medicines, esoteric in formula and varied in effect.  The terms and applications of a warning on such a drug, in order to have meaning, must be explained to the jury.  This is a subject so distinctively related to some science, profession, business or occupation as to be beyond the ken of the average layman.

*          *          *          *

The development of the [drug’s] label required the rendering of medical judgments as to whether essential information concerning risk is sufficiently conveyed; regulatory considerations; and how language in the label might be interpreted by physicians based upon how health services are provided in a given country.  Accordingly, . . . the subject matter . . . [is] not within the common knowledge and experience of the average juror and . . . [requires] expert testimony on the adequacy of the [drug’s] label.”  To find otherwise . . . would be to invite an unsound, unintelligent, and speculative verdict based upon matters beyond the cognition and experience of the average juror.

Id. at 246-47 (many citations and quotation marks omitted).

Thus, “when a claim involves highly complex matters of science, medicine, engineering, technology and the like, which are beyond the common knowledge and experience of the average juror, expert testimony will be necessary.”  Id. at 249.  See Watson v. Inco Alloys International, Inc., 545 S.E.2d 294, 303 (W. Va. 2001) (“questions involving the design of and appropriate warnings for [the product] are not within the common knowledge and experience of a lay juror” and require expert testimony); Addair v. Island Creek Coal Co., 2013 WL 1687833, at *3 (W. Va. April 17, 2013) (“complex illnesses that allegedly have arisen from exposure to chemicals of which the average person has no knowledge or experience” require expert testimony); Crawford v. General Motors Corp., 2007 WL 1960611, at *3 (N.D.W. Va. July 2, 2007) (“expert testimony is required in this case because the issue of whether [the product] was defectively designed or manufactured is well beyond the understanding of the average layman”).

Other West Virginia prescription medical product cases requiring expert testimony are:  Rohrbough v. Wyeth Laboratories, Inc., 916 F.2d 970, 972 (4th Cir. 1990) (“An essential element of plaintiffs’ cause of action is proof that defendant’s vaccine caused plaintiffs’ injuries, and proof of causation must be by expert testimony.”) (applying West Virginia law); Muzichuck v. Forest Laboratories, Inc., 2015 WL 235226, at *11 (N.D. W.Va. Jan. 16, 2015) (summary judgment granted where plaintiff “submitted no expert testimony supporting her proposed alternative means of warning”); Meade v. Parsley, 2010 WL 4909435, at *7 (S.D. W. Va. Nov. 24, 2010) (summary judgment granted enforcing “the general principle that causation evidence in toxic tort cases must be in the form of expert scientific testimony”).


Under Wisconsin law, “[e]xpert testimony is required to prove causation if the matter does not fall within the realm of ordinary experience and lay comprehension.”  Menick v. City of Menasha, 547 N.W.2d 778, 782 (Wis. 1996).  “Expert testimony is often required when unusually complex or esoteric issues are before the jury because it serves to assist the trier of fact.”  Pinter v. Village of Stetsonville, 929 N.W.2d 547, 558 (Wis. 2019) (citation and quotation marks omitted).  “The lack of expert testimony in cases which are so complex or technical that a jury would be speculating without the assistance of expert testimony constitutes an insufficiency of proof.”  Weiss v. United Fire & Casualty Co., 541 N.W.2d 753, 758 (Wis. 1995).

[T]he lack of expert testimony on the question of causation results in an insufficiency of proof where the issue involves technical, scientific or medical matters which are beyond the common knowledge or experience of jurors and the jury could only speculate as to what inference to draw.

Ollman v. Wisconsin Health Care Liability Insurance Plan, 505 N.W.2d 399 (Wis. App. 1993).

These principles apply in Wisconsin product liability and toxic tort litigation.  “[U]nder Wisconsin law, for Plaintiff to support his claims that chemical exposure caused him permanent injury, he must educe supporting qualified expert testimony.”  Kolesar v. United Agri Products, Inc., 412 F. Supp.2d 686, 696 (W.D. Mich. 2006) (applying Wisconsin law), aff’d, 246 F. Appx. 977, 981 (6th Cir. 2007).  A causation “conclusion without any support is not one based on expert knowledge and is not entitled to the dignity of evidence.  It has no scientific basis whatsoever.”  Smith v. Sofamor S.N.C., 21 F. Supp.2d 918, 921 (W.D. Wis. 1998).

Surgical . . . techniques and the adequacy of warnings from implant manufacturers are specialized medical issues and not within the realm of the ordinary experience of mankind”; expert testimony is required to support a defective-warning claim premised on this theory.

In re Zimmer, NexGen Knee Implant Products Liability Litigation, 884 F.3d 746, 753 (7th Cir. 2018) (citation omitted) (applying Wisconsin law).  See Jandrt v. Jerome Foods, Inc., 597 N.W.2d 744, 761 (Wis. 1999) (toxic tort plaintiff’s counsel properly sanctioned for “the absence of any scientific support for the underlying theory of causation . . . [o]nly an expert could have provided the critical link”); Johnson v. Mylan, Inc., 107 F. Supp.3d 967, 976 (E.D. Wis. 2015) (“The plaintiffs have no expert witness who can testify that [the device] was defective, or that it malfunctioned.  Pharmacology, toxicity, and . . . drug delivery are not matters within common knowledge or ordinary experience.”); Schultz v. Glidden Co., 2012 WL 968005, at *2 (E.D. Wis. March 21, 2012) (“To avoid summary judgment in a toxic tort case, the plaintiff must produce admissible expert testimony on the issue of both general and specific causation.”) (citation omitted), rev’d on other grounds, 721 F.3d 426 (7th Cir. 2013); Lemmermann v. Blue Cross Blue Shield, 713 F. Supp.2d 791, 813 (E.D. Wis. 2010) (“plaintiff has no evidence to support critical elements of her duty to warn or strict liability claims.  The expert testimony proffered by the plaintiff screams of unreliability”); Menges v. Depuy Motech, Inc., 61 F. Supp.2d 817, 824 (N.D. Ind. 1999) (“[p]roof of legal causation in a medical device case must be by expert testimony”) (applying Wisconsin law); Valente v. Sofamor, S.N.C., 48 F. Supp.2d 862, 877 (E.D. Wis. 1999) (summary judgment granted because “the plaintiffs fail to offer admissible expert testimony to show that the [medical] device designed, manufactured, promoted, distributed, and sold by the defendants caused the plaintiffs to sustain injuries”); Cali v. Danek Medical, Inc., 24 F. Supp.2d 941, 950 (W.D. Wis. 1998) (summary judgment granted after plaintiff’s experts excluded; “this is a case which requires medical testimony to establish causation between the device and plaintiff’s injury.”); Ruhland v. Walter Kidde Portable Equipment, Inc., 179 F.R.D. 246, 251 (W.D. Wis. 1998) (summary judgment granted; “this product liability action is sufficiently complex as to require expert testimony”).


Wyoming precedent requires expert testimony “[i]f the origin of the injury is obscure and not readily apparent to a layman, or if there are several equally probable causes of the condition.”  Sayer v. Williams, 962 P.2d 165, 168 (Wyo. 1998).  Thus, “expert testimony is required to establish causation unless the injury is immediately and directly or naturally and probably the result of an accident.”  Bodily v. State, 320 P.3d 240, 250 (Wyo. 2014).  See Harris v. Grizzle, 625 P.2d 747, 752 (Wyo. 1981) (“The rule . . . requiring expert testimony is applicable to the case at hand” involving use of a medical device).  In a product liability action, the Wyoming Supreme Court held:

[Plaintiff’s] case rested entirely on unsupported speculation by [an expert].  [Plaintiff] presented no admissible evidence which would indicate that the [product] was not reasonably safe when designed and manufactured; and, therefore, the court properly granted summary judgment

Campbell v. Studer, Inc., 970 P.2d 389, 394 (Wyo. 1998).

Similarly, Wyoming product liability actions involving prescription medical products require expert testimony.

[P]ersonal injury cases involving pharmaceuticals, toxins or medical devices involve complex questions of medical causation beyond the understanding of a layperson.  Complex causal relationships require expert testimony.  Accordingly, [plaintiff] must put forward expert testimony to survive summary judgment and dismissal of his case.

Ronwin v. Bayer Corp., 2008 WL 11427934, at *2 (D. Wyo. Oct. 1, 2008).  Plaintiff lacked admissible expert testimony, and summary judgment was entered.  Id. at *4 (“Without expert reports and testimony to establish a causal link between his seven month [drug] ingestion and his alleged physical injuries, [plaintiff] has failed to establish the existence of a genuine issue of material fact.”).  Summary judgment was affirmed on appeal.  Prescription medical product cases “involve[] complicated causation issues, [such that] all plaintiffs were required to present expert testimony to prove injury and a causal connection.”  Ronwin v. Bayer Corp., 332 F. Appx. 508, 514 (10th Cir. 2009) (“absent expert testimony on causation, summary judgment was appropriate”) (applying Wyoming law).