What follows is the second part of our extensive 50-state of cases precluding plaintiffs from proceeding with claims in the absence of admissible expert support.  Part One was last week.  In most states such rulings originated in medical malpractice and workers’ compensation actions, with the relevant principles broadening to encompass product liability and toxic torts.  We were also pleasantly surprised to see how many of the early decisions establishing the expert support requirement for prescription medical product cases arose from the Bone Screw litigation.  That’s one more gift we left for plaintiffs.  Anyway, here is Part Two, covering from Maryland through Rhode Island.

Maryland

The Maryland Court of Appeals has held that, “lay jurors would not be permitted to draw an inference of negligence without the aid of expert testimony” where a case presents an “issue” of a “complex and technical nature.”  Holzhauer v. Saks & Co., 697 A.2d 89, 96 (Md. 1997).

This is not an “obvious injury” case.  Resolution of the issues of negligence and causation involved in a case of this kind necessarily requires knowledge of complicated matters, including human anatomy, medical science, operative procedures, areas of patient responsibility, and standards of care.  Complex issues of the type generated by a case of this kind should not be resolved by laymen without expert assistance.

Orkin v. Holy Cross Hospital, Inc., 569 A.2d 207, 209 (1990).  “[W]here the cause of an [injury] claimed to have resulted from a negligent act is a complicated medical question involving fact finding which properly falls within the province of medical experts. . ., proof of the cause must be made by such witnesses.”  Wilhelm v. State Traffic Safety Commission, 185 A.2d 715, 719 (Md. 1962) (citations omitted).  See Levitas v. Christian, 164 A.3d 228, 230 (Md. 2017) (“the complex issues of causation in lead paint cases generally require expert testimony”); Aventis Pasteur, Inc. v. Skevofilax, 914 A.2d 113, 135 (Md. 2007) (“a medical expert on specific causation was necessary” because whether vaccines cause autism is “a complex medical question”); Miller v. Mandrin Homes, Ltd., 305 F. Appx. 976, 980 (4th Cir. 2009) (plaintiffs “produced no evidence of medical causation. . . .  The district court properly granted summary judgment.”) (applying Maryland law).

In product liability cases, it is also “well settled that expert testimony is required when the subject of the inference is so particularly related to some science or profession that it is beyond the ken of the average layman.”  Wood v. Toyota Motor Corp., 760 A.2d 315, 319 (Md. Spec. App. 2000) (citations and quotation marks omitted).  “Maryland courts have adopted the general rule that expert testimony is required when the subject of the inference that a product is defective is particularly related to some science or profession that it is beyond the ken of the average layman.”  Jones v. Reichert Jung, Inc., 211 F. Supp.2d 661, 667 (D. Md. 2002) (citing Wood).

[E]xpert testimony is usually necessary since the evidence relating to causation involves technical medical questions beyond the common knowledge of laypersons, and the interaction of a [medical device] with the human body raises technical questions requiring expert testimony.  Thus, if the plaintiff has failed to identify admissible evidence with respect to establishing that the [devices] were defective, and that such defect caused her injuries, then [defendant] is entitled to summary judgment, because each of the tort claims . . . depends upon plaintiff proving both defect, and causation.

Miskin v. Baxter Healthcare Corp., 107 F. Supp.2d 669, 672 (D. Md. 1999) (citations omitted), aff’d, 213 F.3d 632 (4th Cir. 2000) (affirmed “on the reasoning” of the court below).  See John Crane, Inc. v. Linkus, 988 A.2d 511, 522 (Md. App. 2010) (following Wood on causation); American Strategic Insurance Corp. v. Scope Services, Inc., 2017 WL 4098722, at *2 (D. Md. Sept. 15, 2017) (“It is well established under Maryland law that expert testimony is required when the subject of the inference is so particularly related to some science or profession that it is beyond the ken of the average laymen.”) (citation and quotation marks omitted); Osunde v. Lewis, 281 F.R.D. 250, 261 (D. Md. 2012) (“the notion that complicated issues of medical causation require expert testimony is well established in Maryland law”); Selective Insurance Co. v. Empire Comfort Systems, 2007 WL 7681251, at *4 (D. Md. March 21, 2007) (in claims “alleg[ing] the malfunction of complex machinery, expert testimony is required to establish negligence and causation”); Giddings v. Bristol-Myers Squibb Co., 192 F. Supp.2d 421, 423 (D. Md. 2002) (following Miskin); Markey v. Centocor, Inc., 2008 WL 6087370, at *8 (Md. Cir. April 29, 2008) (“Because this case involves numerous drug companies and a drug study . . ., whatever Plaintiffs theory of liability, it necessarily involves a complicated medical question. . . .  Without expert testimony, Plaintiff cannot proceed with her case and the entry of summary judgment in favor of [defendant] would be appropriate.”).

Massachusetts

Massachusetts recognizes that “[m]edical causation has two components, both of which require expert opinion evidence . . . general causation, i.e., that the drug can cause the injury, and specific causation, i.e., that the drug did cause the injury in this case.”  Reckis v. Johnson & Johnson, 28 N.E.3d 445, 461 n.33 (Mass. 2015).  Recognition that medical causation is “a matter beyond the common knowledge of the ordinary layman and proof of it must rest upon expert medical testimony” goes back decades.  Hachadourian’s Case, 162 N.E.2d 663, 666 (Mass. 1959).

The presence of such a defect cannot be inferred in the absence of expert testimony.  The opinion of the nonexperts who testified at trial cannot substitute for this absence of expert testimony.  Lacking expert testimony, other possible causes of the [accident] were not sufficiently eliminated.

Enrich v. Windmere Corp., 616 N.E.2d 1081, 1084 (Mass. 1993) (citations omitted).  “Because understanding medical causation is beyond the . . . knowledge of the ordinary layman . . . proof of it must rest upon expert medical testimony.”  Case of Canavan, 733 N.E.2d 1042, 1051 (Mass. 2000).  Summary judgment is “appropriate” where “[w]ithout the aid of an expert in the field, jurors would also be left to speculate about whether alternatively engineered designs might have prevented the accident.”  Esturban v. Massachusetts Bay Transportation Authority, 865 N.E.2d 834, 836 (Mass. App. 2007).  “[I]f the causation question involves questions of medical science or technology, the jury requires the assistance of expert testimony.”  Held v. Bail, 547 N.E.2d 336, 338 (Mass. App. 1989) (citations omitted).

In product liability cases:

It is also well-settled under Massachusetts law that understanding medical causation is a matter beyond the common knowledge of the ordinary layman and proof of it must rest upon expert medical testimony.  This applies to the requisite showings for both general and specific causation.  Without such expert testimony, a fact finder would have no basis other than conjecture, surmise, or speculation upon which to conclude that the injuries of which a plaintiff complains were caused by the impact of the Defendants’ product.

Jackson v. Johnson & Johnson, 330 F. Supp.3d 616, 625 (D. Mass. 2018) (citations and quotation marks omitted).  See Goffredo v. Mercedes-Benz Truck Co., 520 N.E.2d 1315, 1319 (Mass. 1988) (“[w]ithout the testimony of an expert . . ., the evidence was insufficient to establish that the design of the [product] was defective and that the defect caused” plaintiff’s injuries); Milward v. Rust-Oleum Corp., 820 F.3d 469, 476 (1st Cir. 2016) (“expert testimony is required to establish medical causation”; “This applies to both general and specific causation.”) (applying Massachusetts law); Hochen v. Bobst Group, Inc., 290 F.3d 446, 451 (1st Cir. 2002) (“here the nature of the defect or breach of warranty and its causal relation to the accident were complex and thus appropriately the subject of expert testimony”) (applying Massachusetts law); Carrozza v. CVS Pharmacy, Inc., ___ F. Supp.3d ___, 2019 WL 2913987, at *6 (D. Mass. July 8, 2019) (“in Massachusetts expert testimony is required on highly technical medical issues, including injury causation”) (citation and quotation marks omitted); Williams v. Techtronic Industries North America, Inc., 2014 WL 2865874, at *5 (D. Mass. June 23, 2014), (“In products liability cases, where the causal link between the alleged defect and the accident are beyond the ken of the jury, expert testimony is necessary to defeat summary judgment.”), aff’d, 600 F. Appx. 1 (1st Cir. 2015); Calisi v. Abbott Laboratories, 2013 WL 5441355, at *15 (D. Mass. Sept. 27, 2013) (“Under Massachusetts law, when the nature of the defect or breach of warranty and its causal relation to the [injury is] complex, a plaintiff must introduce expert testimony.”) (citations and quotation marks omitted); Carlucci v. CNH America LLC, 2012 WL 4094347, at *10 (D. Mass. Sept. 14, 2012) (“a plaintiff generally must provide expert testimony when the product is complex or technical such that it is beyond the common knowledge of the jury”); Kerlinsky v. Sandoz Inc., 783 F. Supp.2d 236, 242 (D. Mass. 2011) (“the issue of medical causation requires expert analysis”); Langadinos v. Hosokawa Micron International, Inc., 2011 WL 1213079, at *1 (D. Mass. March 31, 2011) (“given the nature of the injury and complexity of the relevant machinery, expert testimony is necessary to support plaintiff’s claims”); Pritchard v. Stanley Access Technologies, LLC, 2011 WL 309662, at *5 (D. Mass. Jan. 27, 2011) (“a jury could not reasonably conclude, on the basis of the evidence of record and in the absence of expert testimony, that Defendants’ negligence was more likely than not the cause of [plaintiff’s] alleged injuries”) (emphasis original); In re Neurontin Marketing & Sales Practices & Products Litigation, 2010 WL 3169485, at *2 (D. Mass. Aug. 10, 2010) (summary judgment granted where “plaintiff does not have an expert who will testify that [the drug] specifically caused her symptoms”); Morse v. Ford Motor Co., 2010 WL 2773527, at *1 (D. Mass. July 13, 2010) (“In cases involving claims of product defect (such as this case), expert testimony is required because the answers to the highly technical and specialized questions raised by such claims lie outside the knowledge of most lay jurors.”); Alves v. Mazda Motor of America, Inc., 448 F. Supp.2d 285, 301 (D. Mass. 2006) (“As expert evidence is essential to [plaintiff’s] case, the defendants are clearly entitled to prevail now that their evidence is being excluded.”); Polaino v. Bayer Corp., 122 F. Supp.2d 63, 71 (D. Mass. 2000) (“without such [expert] testimony, plaintiff can prove neither a design defect nor causation”).

Michigan

Michigan law has “long recognized the importance of expert testimony . . . to educate the jury and the court regarding matters not within their common purview.”  Locke v. Pachtman, 521 N.W.2d 786, 790 (Mich. 1994).  See Woodard v. Custer, 702 N.W.2d 522, 525 (Mich. 2005) (quoting and following Locke).  Likewise, determining causation in toxic tort cases is “scientific in nature . . . [so] it is to the scientific community that the law must look for the answer.  For this reason, expert witnesses are indispensable.”  Nelson v American Sterilizer Co., 566 N.W.2d 671 (Mich. App. 1996).  “[I]n toxic tort cases involving complex chemicals and their effects on human health, expert testimony is often required because the alleged injuries are not immediately obvious and the connection between exposure and injury is not a matter of common sense or everyday experience.”  Hendrian v. Safety-Kleen Systems, Inc., 2015 WL 4770966, at *4 (E.D. Mich. Aug. 13, 2015) (citation and quotation marks omitted).  See also Lowery v. Enbridge Energy Ltd. Partnership, 898 N.W.2d 906, 917-18 (Mich. 2017) (“expert testimony on causation is necessary in a toxic tort case when the legal proposition is beyond the common knowledge of an ordinary juror”) (Markman, C.J., concurring).

The same is true in product liability.

Plaintiffs have failed to proffer expert evidence . . . to support their contention that [the medical device] . . . caused [the] injuries in this case.  This requires the Court to grant Defendant’s motion for summary judgment. . . .  [E]xpert testimony is indispensable to prove causation where it is to the scientific community that the law must look for the answer.”

Avendt v. Covidien, Inc., 262 F. Supp.3d 493, 532 (E.D. Mich. 2017) (citations and quotation marks omitted).  See Swartz v. Procter & Gamble Manufacturing Co., 2018 WL 2239558, at *5 (E.D. Mich. May 16, 2018) (“expert testimony is required to demonstrate the existence of a reasonable alternative design that would satisfy the elements of a plaintiff’s claim”); In re Dow Corning Corp., 541 B.R. 643, 654 (E.D. Mich. 2015) (“Both causation inquiries − general and specific − involve scientific assessments that must be established through the testimony of a medical expert.”), aff’d, 667 F. Appx. 538 (6th Cir. 2016); Eiben v. Gorilla Ladder Co., 2013 WL 1721677, at *16 (E.D. Mich. April 22, 2013 (“Because the expert’s testimony is inadmissible, . . . Plaintiff’s claim of design defect cannot survive summary judgment.”); Dow v. Rheem Manufacturing Co., 2011 WL 4484001, at *22 (E.D. Mich. Sept. 26, 2011) (“expert testimony on causation is necessary, where the claim presents technical issues that are beyond the common experience and understanding of the common juror.”) (citations and quotation marks omitted), aff’d, 527 F. Appx. 434 (6th Cir. 2013); Gillett v. Sofamor, S.N.C., 2001 WL 1135304, at *6 (E.D. Mich. Sept. 13, 2001) (without expert testimony “Plaintiff has not presented sufficient evidence to establish a prima facie case that an alternative design was available”); Berry v. Crown Equipment Corp., 108 F. Supp.2d 743, 756 (E.D. Mich. 2000) (“In the absence of expert testimony concerning reasonableness of the plaintiff’s proposed alternative design, a manufacturer is entitled to entry of judgment as a matter of law.”).

Minnesota

In Minnesota, “[e]xpert opinion is required to prove causation if the issue is outside the realm of common knowledge.”  Walton v. Jones, 286 N.W.2d 710, 715 (Minn. 1979).

It is well-settled law . . . that the need for positive expert testimony to establish a causal connection between the defendant’s negligent act and the plaintiff’s injury or condition depends upon the nature of the question.  Where the question involves obscure and abstruse medical factors such that the ordinary layman cannot reasonably possess well-founded knowledge of the matter and could only indulge in speculation in making a finding, there must be expert testimony, based on an adequate factual foundation, that the thing alleged to have caused the result not only might have done so, but in fact did cause it.

Stahlberg v. Moe, 166 N.W.2d 340, 345 (Minn. 1969) (citations omitted).  “Where a question involves obscure and abstruse medical factors such that the ordinary [lay person] cannot reasonably possess well-founded knowledge in the matter and could only indulge in speculation . . . there must be expert testimony.”  Gross v. Victoria Station Farms, Inc., 578 N.W.2d 757, 762 (Minn. 1998) (citation and quotation marks omitted).  Thus, “[e]xpert testimony is generally required” in cases that “involve complex scientific or technological issues.”  Mercer v. Andersen, 715 N.W.2d 114, 122 (Minn. App. 2006).

The rule in product liability is the same.  “[P]ersonal injury cases involving pharmaceuticals, toxins or medical devices involve complex questions of medical causation beyond the understanding of a lay person.”  In re Baycol Products Litigation, 321 F. Supp.2d 1118, 1126 (D. Minn. 2004).  “Under Minnesota law, expert testimony is required to prove causation in cases involving complex medical issues with which a jury is unlikely to have experience.”  In re Viagra Products Liability Litigation, 658 F. Supp.2d 950, 968 (D. Minn. 2009) (quoting Johnson v. Zimmer, Inc., 2004 WL 742038, at *6 (D. Minn. March 31, 2004)).  See Fireman’s Fund Insurance Co. v. Canon U.S.A., Inc., 394 F.3d 1054, 1060-61 (8th Cir. 2005) (“Absent the excluded opinions of the . . . experts, [plaintiff] presented no evidence of any defect in the [product].”) (applying Minnesota law); Polski v. Quigley Corp., 2007 WL 2580550, at *11 (D. Minn. Sept. 5, 2007) (“Because the Court will not permit [plaintiffs’ expert] to testify that [the product] caused [their] injuries, [plaintiffs] will not be able to establish causation at trial.”), aff’d, 538 F.3d 836 (8th Cir. 2008); Rye v. Matrixx Initiatives, Inc., 2007 WL 2475960, at *4 (D. Minn. Aug. 24, 2007) (also quoting Johnson); Willert v. Ortho Pharmaceutical Corp., 995 F. Supp. 979, 983 (D. Minn. 1998) (“the present case involves such obscure and abstruse medical questions requiring competent expert testimony”).

Mississippi

In Mississippi litigation, “[e]xpert testimony is required unless the matter in issue is within the common knowledge of laymen.”  Denham v. Holmes, 60 So.3d 773, 789 (Miss. 2011) (quoting Palmer v. Biloxi Regional Medical Center, Inc., 564 So.2d 1346, 1355 (Miss. 1990)). “ In all but the simple and routine cases, it is necessary to establish medical causation by expert testimony.”  Short v. Wilson Meat House, LLC, 36 So.3d 1247, 1253 (Miss. 2010) (citation and quotation marks omitted).  Thus, “Mississippi law requires expert medical testimony where causation is an issue in a complicated case because such determinations are generally outside the scope of the average experiences and qualifications of most lay jurors.”  Brown v. Eli Lilly & Co., 654 F.3d 347, 358 (2d Cir. 2011) (applying Mississippi law).

Similar holdings under Mississippi law have occurred in product liability and toxic tort cases.  See Savage v. Pilot Travel Centers, L.L.C., 464 F. Appx. 288, 290 (5th Cir. 2012) (“Under Mississippi law, actions involving ‘medically complicated’ injuries require expert testimony on causation.”) (applying Mississippi law); Hill v. Koppers, Inc., 2009 WL 4908836, at *7-8 (N.D. Miss. Dec. 11, 2009 (Daubert exclusion of plaintiff’s experts created a “complete failure of proof . . . on general and specific causation”); Berry v. Southwest Airlines Co., 2008 WL 3874368, at *3 (S.D. Miss. Aug. 15, 2008) (“with injuries that are medically complicated, as is the case here, expert testimony is required to prove causation”); Jackson v. Bayer Corp., 2007 WL 2580379, at *4 (S.D. Miss. Sept. 4, 2007) (applying Mississippi law) (plaintiffs “have not offered any expert proof at all . . . that [the drug] caused or contributed to the plaintiffs’ alleged injuries and damages.  Failure to offer evidence on a critical matter upon which they bear the burden is fatal to their case”).

Missouri

Under the law of Missouri, “[m]edical causation, which is not within common knowledge or experience, must be established by scientific or medical evidence showing the relationship between the complained of condition and the asserted cause.”  Malam v. State, Dept. of Corrections, 492 S.W.3d 926, 929 (Mo. 2016) (quoting Gordon v. City of Ellisville, 268 S.W.3d 454, 461 (Mo. App. 2008)).

When a fact at issue is so technical or complex that no fact finder could resolve the issue without expert testimony, expert testimony is necessary and, therefore, required.  For example, expert testimony has been required to explain the results of medical tests and blood work . . . or to establish causation when there is a sophisticated injury that involves a highly scientific technique for diagnosis.

Stone v. Missouri Dept. of Health & Senior Services, 350 S.W.3d 14, 21 (Mo. 2011) (citations and quotation marks omitted).  “Proof of causation generally requires expert testimony to establish the causal connection between the accident and the injury.”  Host v. BNSF Railway Co., 460 S.W.3d 87, 104 (Mo. App. 2015).

This rule is applied in toxic tort and product liability litigation.  “[C]ausation in cases involving exposure to a toxic substance typically requires a certain degree of scientific expertise.”  Brown v. Seven Trails Investors, LLC, 456 S.W.3d 864, 869 (Mo. App. 2014).  “The nature of [a] medication’s side effects, the doses necessary to manifest those effects, and the biomedical interaction of [different] medications are all matters beyond that of a layperson’s common knowledge and experience.”  Love v. Waring, 560 S.W.3d 614, 620 (Mo. App. 2018).  “[E]xpert testimony is necessary” in product liability cases where “the lay jury [does] not possess the experience or knowledge of the subject matter sufficient to enable them to reach an intelligent opinion without help.”  Pro Service Automotive, L.L.C. v. Lenan Corp., 469 F.3d 1210, 1214 (8th Cir. 2006) (applying Missouri law) (quoting Wright v. Barr, 62 S.W.3d 509, 524 (Mo. App. 2001)).  See Redd v. DePuy Orthopaedics, Inc., 700 F. Appx. 551, 555 (8th Cir. 2017) (summary judgment affirmed because “the fracture of [plaintiff’s] . . . implant was a sophisticated injury, and [plaintiff] lacked any admissible expert testimony on the cause of that fracture”) (applying Missouri law); Menz v. New Holland North America, Inc., 507 F.3d 1107, 1112 (8th Cir. 2007) (“The district court did not abuse its discretion in concluding a lay jury would lack the experience and knowledge necessary to determine causation on [plaintiff’s] warnings claim without the aid of expert testimony.”) (applying Missouri law); Turner v. Iowa Fire Equipment Co., 229 F.3d 1202, 1210 (8th Cir. 2000) (“Without [an expert] opinion that the [product] exposure caused the . . . injuries, [plaintiffs] cannot prove causation.”) (applying Missouri law); Howard v. Bosch Thermotechnology Corp., 2018 WL 2087259, at *3 (E.D. Mo. May 4, 2018) (expert testimony “is necessary if determining a relevant factual issue involves information that is so complex or technical that no fact finder could resolve the issue without help”); Hoover v. Bayer Healthcare Pharmaceuticals, Inc., 2017 WL 2313177, at *4 (W.D. Mo. Jan. 11, 2017) (“Without reliable expert testimony concerning specific causation . . ., the Court concludes Plaintiff is unable to establish the necessary element of causation.”); Martin v. Crown Equipment Corp., 2008 WL 11337826, at *3 (W.D. Mo. Jan. 16, 2008) (“[w]hen a failure-to-warn claim involves technical and complex machinery not commonly utilized by typical lay jurors, it is appropriate for the Court to require expert testimony”); Hilton v. Ethicon, Inc., 2007 WL 541603, at *3 (W.D. Mo. Feb. 16, 2007) (“Without such expert testimony, Plaintiff cannot establish causation.”); Looney v. Zimmer, Inc., 2004 WL 1918720, at *5 (W.D. Mo. Aug. 19, 2004) (“When an injury is sophisticated, proof of causation generally must be established by expert testimony.”); Shaffer v. Amada America, Inc., 335 F. Supp.2d 992, 998 (E.D. Mo. 2003) (plaintiff “needs competent expert testimony to establish that this [product] is defective and unreasonably dangerous”); Glastetter v. Novartis Pharmaceuticals Corp., 107 F. Supp.2d 1015, 1045 (E.D. Mo. 2000) (Daubert exclusion of plaintiff’s experts created “the absence of any scientifically valid evidence supporting plaintiffs’ theory of causation,” requiring summary judgment), aff’d, 252 F.3d 986 (8th Cir. 2001);  Eppler v. Ciba-Geigy Corp., 860 F. Supp. 1391, 1395 (W.D. Mo. 1994) (in “a product liability action of a highly technical and scientific nature, expert testimony is essential to establish causation”).

Montana

In Montana, matters “not readily apparent to a layman” “obligate[ the plaintiff] to present expert testimony.”  Dubiel v. Montana Dep’t of Transportation, 272 P.3d 66, 70 (Mont. 2012).  “[E]xpert testimony is required when the issue presented is sufficiently beyond the common experience of the trier of fact and the expert testimony will assist the trier of fact in determining the issue or understanding the evidence.”  Hinkle v. Shepherd School Dist. No. 37, 93 P.3d 1239, 1246 (Mont. 2004).  Accord Dayberry v. City of East Helena, 80 P.3d 1218, 1220-21 (Mont. 2003) (same language).

A Plaintiff’s testimony alone is not sufficient “to establish causation of the injury where the nature of the injury is such that laymen can neither plainly see, nor infer from the injury. . . .  Rather, qualified medical testimony from an expert witness is necessary to prove the cause … of such injuries.”

Green v. Montana Dep’t of Public Health & Human Services, 2014 WL 12591834, at *6 (D. Mont. Jan. 3, 2014) (quoting Bleek v. Supervalu, Inc., 95 F. Supp.2d 1118, 1121 (D. Mont. 2000)).  See Horob v. McCone County, 2010 WL 5441961, at *1 (D. Mont. Dec. 28, 2010) (“evidence of causation must be proved with expert medical testimony unless the cause of injury is obvious”), aff’d, 507 F. Appx. 679 (9th Cir. 2013); Wilderness Development, LLC v. Hash, 606 F. Supp.2d 1275, 1281 (D. Mont. 2009) (“the causation issue will require the trier of fact to resolve issues beyond the common experience and knowledge of lay people and, thus, expert testimony will be required”).

The same is true in product liability and toxic tort cases.  In a prescription drug case the Montana Supreme Court held:

There are no Montana cases specifically holding that a plaintiff must produce expert testimony to sustain an action against a drug company for failure to warn adequately of side effects of its products.  There are, however, numerous Montana decisions to the effect that, in a malpractice suit . . . , expert evidence is the only proper guide and without it a plaintiff cannot recover.  We hold that the reasoning of these decisions extends to the situation involved here.  In matters with respect to which a layman can have no knowledge at all, the court and jury must be dependent on expert evidence.  The adequacy of a warning directed to physicians is such a matter.

Hill v. E.R. Squibb & Sons, 592 P.2d 1383, 1388 (Mont. 1979) (citations omitted).  Where a product liability “case involves matters beyond the common experience of a lay juror . . ., summary judgment dismissal is warranted if the plaintiff fails to present expert testimony necessary to prove the elements of his negligence claim.”  Stacy v. BNSF Railway Co., 2015 WL 1433679, at *2 (D. Mont. March 27, 2015).  See Wilhelm v. Pfizer, Inc., 2016 WL 5030359, at *4 (D. Nev. Sept. 19, 2016) “the Court finds that expert testimony is required to establish causation as to all of [plaintiff’s] claims”) (applying Montana law); Brumbaugh v. Sandoz Pharmaceutical Corp., 77 F. Supp.2d 1153, 1157 (D. Mont. 1999) (without expert testimony, “plaintiff is unable to generate a genuine issue of material fact with respect to causation, an essential element of her claim”).

Nebraska

Nebraska courts hold that “[e]xpert testimony is almost always required to prove proximate causation.”  Ewers v. Saunders County, 906 N.W.2d 653, 664 (Neb. 2018) (quoting Thone v. Regional West Medical Center, 745 N.W.2d 898, 908 (Neb. 2008)).  Medically complicated questions requir[e] expert testimony” so that “the cause and extent of [plaintiff’s] injuries must be substantiated by expert testimony.”  Doe v. Zedek, 587 N.W.2d 885, 891-92 (Neb. 1999).  “Unless its nature and effect are plainly apparent, an injury is a subjective condition requiring an expert opinion to establish a causal relationship between the incident and the injury or disability.”  Bernhardt v. County of Scotts Bluff, 482 N.W.2d 262, 263 (Neb. 1992) (syllabus).

[W]here the claimed injuries are of such a character as to require skilled and professional persons to determine the cause and extent thereof, the question is one of science.  Such a question must necessarily be determined from testimony of skilled professional persons and cannot be determined from the testimony of unskilled witnesses having no scientific knowledge of such injuries.

Hohnstein v. W.C. Frank, 468 N.W.2d 597, 602 (Neb. 1991).

In product liability cases, “[e]xpert evidence is required to establish the elements of causation and defect.”  Barrett v. Rhodia, Inc., 606 F.3d 975, 984 (8th Cir. 2010) (applying Nebraska law).  Like other “cases involving complex technical, medical, or scientific issues, causation must be established by expert testimony.”  Vallejo v. Amgen, Inc., 274 F. Supp.3d 922, 925 (D. Neb. 2017), aff’d, 902 F.3d 733 (8th Cir. 2018).

Ordinarily, in medical cases, product defect and medical causation must be established by expert testimony.  Similarly, the 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.  Where 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.

Uribe v. Sofamor, S.N.C., 1999 WL 1129703, at *7 (D. Neb. Aug. 16, 1999) (citations, quotation marks, and footnote omitted).  See Schafersman v. Agland Coop, 681 N.W.2d 47, 56 (Neb. 2004) (“the court correctly entered summary judgment” in product liability case after excluding plaintiff’s experts); “whether or not a drug causes an individual to [suffer injury] is a complex factual question”; Grant v. Pharmative, LLC, 452 F. Supp.2d 903, 910 (D. Neb. 2006) (“Without evidence to establish both general and specific causation, plaintiffs cannot survive defendants’ motions for summary judgment.”); Nuzum v. Chlorella, 2006 WL 3825111, at *2 (D. Neb. Dec. 27, 2006) (“the plaintiff cannot establish essential elements of his products liability claim without expert testimony”).

Similarly, “expert testimony was necessary to establish the basis for an inference that [plaintiff’s] injuries were caused by the inhalation of fumes.”  McNeel v. Union Pacific Railroad Co., 753 N.W.2d 321, 329 (Neb. 2008).  “In a toxic tort case, the plaintiff’s expert evidence must show that the toxin was the cause of the plaintiff’s injury.”  Barrett, 606 F.3d at 984 (citation and quotation marks omitted).

Nevada

Under Nevada law, “generally, because an injury is a subjective condition, an expert opinion is required to establish a causal connection between the incident or injury and disability.”  Grover C. Dils Medical Center v. Menditto, 112 P.3d 1093, 1100 (Nev. 2005).  “[I]f the plaintiff’s medical expert cannot form an opinion . . ., there is nothing on the record with which a jury can make a decision.”  Morsicato v. Sav-On Drug Stores, Inc., 111 P.3d 1112, 1116 (Nev. 2005) (citation and quotation marks omitted).  “Causation in toxic tort litigation is generally proven by expert testimony.”  Jernee v. Kennametal, Inc., 2015 WL 134767, at *1 (Nev. Jan. 8, 2015) (unpublished).  “When, as here, the cause of injuries is not immediately apparent, the opinion as to the cause should be given by one qualified as a medical expert.”  Lord v. State, 806 P.2d 548, 551 (Nev. 1991).

[Plaintiff] failed to timely disclose any expert witness or treating physician to testify regarding causation. . . .  Since [plaintiff] could not show causation, he failed to establish each element of his negligence claims.  Thus, summary judgment was appropriate.

Elliott v. City Center Veer Towers Development, LLC, 2018 WL 2041490, at *2 (Nev. App. April 20, 2018) (also quoting and following Grover).

Thus, “[u]nder Nevada law, Plaintiffs must produce medical expert testimony to establish causation, particularly where the cause of death is not immediately apparent.”  Neal-Lomax v. Las Vegas Metro. Police Dep’t, 574 F. Supp.2d 1193, 1199 (D. Nev. 2008), aff’d, 371 F. Appx. 752 (9th Cir. 2010).  See Elliott v. Prescott Cos., LLC, 2018 WL 3731087, at *5 (D. Nev. Aug. 6, 2018) (“the causal relationship between [the] chemicals and [plaintiff’s] alleged injuries is not immediately apparent or within the comprehension of the ordinary layperson.  As such, expert testimony is required to prove causation.”); Blackmon v. New Albertson’s Inc., 2012 WL 3613956, at *3 (D. Nev. Aug. 21, 2012) (“Nevada law requires an expert opinion to establish a causal connection between the incident and the injury.”); Thompson v. TRW Automotive, Inc., 2015 WL 5474448, at *5 (D. Nev. Sept. 17, 2015) (“expert testimony . . . is necessary because the issues are complicated and often far beyond an ordinary juror’s understanding”) (citation and quotation marks omitted), aff’d, 694 F. Appx. 566 (9th Cir. 2017); Blackmon v. New Albertson’s, Inc., 2011 WL 4958631, at *2 (D. Nev. Oct. 17, 2011) (“It is well-settled law that in a personal injury action causation must be proven within a reasonable medical probability based upon competent medical testimony.”) (citation and quotation marks omitted); Duenas v. United States, 2006 WL 8441980, at *5 (D. Nev. Feb. 15, 2006) (“On the basis that Plaintiff has failed to put forth reliable medical expert testimony or treatises as to injuries, we will grant Defendant’s motion for summary judgment”); Layton v. Yankee Caithness Joint Venture, L.P., 774 F. Supp. 576, 580 (D. Nev. 1991) (“[W]here a question of fact is beyond the comprehension of the ordinary lay person, expert testimony is required to prove that fact.”).

New Hampshire

New Hampshire law holds that “[e]xpert testimony is required where the subject presented is so distinctly related to some science, profession or occupation as to be beyond the ken of the average layperson.”  Estate of Sicotte v. Lubin & Meyer, P.C., 959 A.2d 236, 239 (N.H. 2008).  “The medical causation of [an . . .] injury of this nature is a matter properly within the province of medical experts.”  Appeal of Briggs, 645 A.2d 655, 659 (N.H. 1994).

To determine whether expert testimony is required, we must determine whether this issue . . . is within the realm of common knowledge and everyday experience of the average layman, or whether an expert opinion is needed to preclude the jury from engaging in idle speculation. . . .  Expert testimony is required if any inference of the requisite causal link must depend on observation and analysis outside the common experience of jurors.

Stachulski v. Apple New England, LLC, 191 A.3d 1231, 1241 (N.H. 2018) (citations and quotation marks omitted).  See Smith v. HCA Health Services, Inc., 977 A.2d 534, 539 (N.H. 2009) (“The plaintiffs’ claims are actions for medical injury that require expert testimony”); Carbone v. Tierney, 864 A.2d 308, 315 (N.H. 2004) (“The facts of this case are thus sufficiently complicated to require expert testimony with respect to causation.”); Sawyer v. Purdue Pharmaceutical Corp., 2013 WL 6840145, at *7 (M.D. Pa. Dec. 27, 2013) (“[o]nly a qualified expert could provide the jury an informed basis upon which to conclude that [defendant] did not exercise reasonable care in the manufacture and design of [its drug]”; “the jury could reasonably conclude that [defendant] provided inadequate warnings only with the help of expert opinion”) (applying New Hampshire law); Grimes v. Hoffmann-LaRoche, Inc., 907 F. Supp. 33, 38-39 (D.N.H. 1995) (granting summary judgment in prescription medical product liability action after exclusing plaintiff’s expert).

New Jersey

A plaintiff in New Jersey is “required to produce an expert” when the case involves “a complex process involving assessment of a myriad of factors that is beyond the ken of the average juror.”  Davis v. Brickman Landscaping, Ltd., 98 A.3d 1173, 1180 (N.J. 2014).

[C]ertain claims require expert testimony.  In tort actions, whether expert testimony is needed in respect of breach of duty depends on whether the matter to be dealt with is so esoteric that jurors of common judgment and experience cannot form a valid judgment about a party’s conduct.  Similarly, cases have found expert testimony to be required in certain types of actions in connection with proof of other tort elements.

Phillips v. Gelpke, 921 A.2d 1067, 1073 (N.J. 2007) (citations and quotation marks omitted).

Thus, “New Jersey law does require expert testimony, however, in cases where lay jurors confront causation issues that are too complex to be understood without the assistance of specialized expert testimony.”  Tormenia v. First Investorrs Realty Co., 251 F.3d 128, 132 (3d Cir. 2000) (applying New Jersey law) (emphasis original).  Tormenia followed Kelly v. Borwegen,

[W]here a claimed disability is the natural result of the injuries sustained, the jury may, without expert opinion, find that the injuries caused such disability.  However, when an injury is such as to require skilled men to determine its cause and extent, the question is one of science, and must be established by skilled professional persons.

230 A.2d 532, 534 (N.J. Super. App. Div. 1967) (citation and quotation marks omitted).  Similarly, “[w]here the allegedly defective product involves a complex instrumentality, a plaintiff is required to provide expert testimony,” since “[e]xpert testimony is necessary to assist the fact finder in understanding ‘the mechanical intricacies of the instrumentality.”  Lauder v. Teaneck Volunteer Ambulance Corps, 845 A.2d 1271, 1277 (N.J. Super. App. Div. 2004).  “A factfinder should not be allowed to speculate without the assistance of expert testimony in an area where the average person could not be expected to have sufficient knowledge or experience.”  State v. Doriguzzi, 760 A.2d 336, 341 (New Jersey Super. App. Div. 2000) (citation omitted).  A more recent decision of the same court agrees:

The topic is plainly outside the common knowledge of the average juror.  Plaintiff needed a medical expert to address these key issues of medical causation, but did not retain one.  This critical shortcoming pertains as to both the wrongful death claim and the survival claim. . . .  [A] lay inference is simply not enough to get the complex issues of medical causation before a jury.

Quail v. Shop-Rite Supermarkets, Inc., 188 A.3d 348, 358 (N.J. Super. App. Div. 2018) (citation omitted).

New Jersey’s expert testimony requirement also applies in product liability and toxic tort cases.  “[W]e hold that in toxic-tort litigation, a scientific theory of causation . . . must be proffered by an expert who is sufficiently qualified.”  Rubanick v. Witco Chemical Corp., 593 A.2d 733, 747-48 (N.J. 1991).  “It is well-settled law that where the allegedly defective product involves a complex instrumentality, a plaintiff is required to provide expert testimony.”  Toms v. J.C. Penney Co., 2007 WL 2893052, at *4 (D.N.J. Sept. 28, 2007), aff’d, 304 F. Appx. 121 (3d Cir. 2008).  “When the proofs involve a defect in a complex instrumentality, an expert is frequently required to assist the jury in understanding the mechanical intricacies and weighing competing theories of causation.”  Ford Motor Credit Co., LLC v. Mendola, 448 A.3d 366, 372 (N.J. Super. App. Div. 2012) (citing Lauder).

Courts generally recognize that plaintiffs in products liability cases must offer admissible expert testimony regarding both general causation and specific causation. . . .  Expert testimony is generally required in product liability cases because it prevents the jury from engaging in speculation in determining the causal link between using or ingesting the product and the injuries complained of following that use.  Determining that causal link typically requires complex medical information beyond the knowledge, understanding, and experience of a lay juror.  Expert testimony typically provides this link.

In re Benicar (Olmesartan) Products Liability Litigation, 2016 WL 6652358, at *2 (D.N.J. Nov. 9, 2016) (citations omitted).  See Ace Pallet Corp. v. Consolidated Rail Corp., 764 F. Appx. 197, 199 (3d Cir. 2019) (affirming summary judgment under Tormenia following exclusion of plaintiff’s experts) (applying New Jersey 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”); Huddell v. Levin, 537 F.2d 726, 736 (3d Cir. 1976) (“where the issue concerns a product’s design . . . expert opinion is the only available method to establish defectiveness”) (applying New Jersey law); Hettinger v. Speedline Technology, Inc., 2014 WL 5410620, at *5 (D.N.J. Oct. 22, 2014) (“In the instant matter, an expert opinion is required to prove this vital element of causation for both the design defect and failure to warn claims because the [product] constitutes a ‘complex instrumentality.’”); Sampson v. Glock, Inc., 2014 WL 1225581, at *3 (D.N.J. March 24, 2014) (“given the complex nature of the [product], Plaintiff must rely on the testimony of an expert”); Leese v. Martin, 2013 WL 5476415, at *8 (D.N.J. Sept. 30, 2013) (“As a general proposition, expert testimony is required to demonstrate causation in toxic tort cases.”) (citations omitted); Mays v. General Binding Corp., 2013 WL 1986393, at *6 (D.N.J. May 10, 2013) (quoting Lauder), aff’d, 565 F. Appx. 94 (3d Cir. 2014); Sanders v. Rosenberg, 2008 WL 1732980, at *3 (D.N.J. April 10, 2008) (“in cases concerning toxic torts . . ., testimony of an expert is required, in particular with regard to causation”); Amico v. Duracal Cement, 2006 WL 2319313, at *7 (D.N.J. Aug. 9, 2006) (“Without expert medical testimony there is no evidence of causation to support any of [plaintiff’s] negligence/products liability claims.”); Appleby v. Glaxo Wellcome, Inc., 2005 WL 3440440, at *7 (D.N.J. Dec. 13, 2005) (“Without an expert, it is impossible to evaluate the evidence to ascertain whether the risk of [the drug] sufficiently outweighs its benefit”); Ortiz v. Yale Materials Handling Corp., 2005 WL 2044923, at *2 (D.N.J. Aug. 24, 2005) (“Where the allegedly defective product involves a complex instrumentality, a plaintiff is required to provide expert testimony.”); In re Norplant Contraceptive Products Liability Litigation, 215 F. Supp.2d 795, 830 (E.D. Tex. 2002) (“Evidence of general causation must be provided in the form of expert testimony.”) (citations omitted) (applying New Jersey law); Snodgrass v. Ford Motor Co., 2001 WL 37118915, at *5 (D.N.J. Aug. 31, 2001) (“Where a plaintiff fails to come forward with an expert’s report on a complicated causation issue, summary judgment is appropriate.”); Rutigliano v. Valley Business Forms, 929 F. Supp. 779, 783 (D.N.J. 1996) (“Plaintiff’s case requires expert testimony to satisfy her burden with respect to both general causation and specific causation.”), aff’d, 118 F.3d 1577 (3d Cir. 1997).

New Mexico

Expert testimony in New Mexico “is required to establish an element of a claim or defense [because] it would assist the jury to understand issues in the case that are beyond their knowledge.”  State v. Campbell, 157 P.3d 722, 725 (N.M. 2007).  “To prove a proposition to a reasonable medical probability requires expert medical testimony establishing that the proposition is more likely than not.”  Baca v. Bueno Foods, 766 P.2d 1332, 1334 (N.M. 1988) (citation omitted).  With “issues involv[ing] a complex professional assessment.  It follows that jurors would also require expert testimony.”  Holley v. Evangelical Lutheran Good Samaritan Society, 588 F. Appx. 792, 796 (10th Cir. 2014) (applying New Mexico law).  Where “expert knowledge is essential to the formation of an intelligent opinion, only an expert can competently give opinion evidence as to the cause of death, disease, or a physical condition.”  Woods v. Brumlop, 377 P.2d 520, 522 (N.M. 1962).  See Holley v. Evangelical Lutheran Good Samaritan Society, 588 F. Appx. 792, 796 (10th Cir. 2014) (summary judgment affirmed where issues were “not within the common knowledge ordinarily possessed by an average person,” and plaintiff’s expert excluded) (applying New Mexico law); Montoya v. Ramos, 2017 WL 5654791, at *1 (D.N.M. Sept. 25, 2017) (“diagnoses of complex mental conditions are generally beyond the common experience of lay persons and require special skill or knowledge”); Safford v. Wal-Mart Stores, Inc., 2017 WL 2306410, at *6 (D.N.M. Feb. 16, 2017) (“plaintiffs cannot prevail on the issue of medical causation without expert testimony directly supporting their conclusion”) (citation omitted); American Mechanical Solutions, L.L.C. v. Northland Process Piping, Inc., 184 F. Supp.3d 1030, 1067 (D.N.M. 2016) (“when the issue of causation . . . cannot be determined by resort to common knowledge that an average person ordinarily possesses, New Mexico law requires expert testimony”); Duke v. Garcia, 2014 WL 1333151, at *3 (D.N.M. Feb. 28, 2014) (“the medical situation is complex, and actions involving medically complicated injuries require expert testimony on causation”) (citation and quotation marks omitted).

Similar considerations mandate reliance on expert witnesses in product liability and toxic tort cases in New Mexico.  In “toxic tort cases like the one before us, the determination of the external cause of a patient’s disease is a complex process . . . which requires specialized scientific knowledge regarding the external agents involved.”  Parkhill v. Alderman-Cave Milling & Grain Co., 245 P.3d 585, 590 (N.M. App. 2010).  Thus, in Firstenberg v. Monribot, 350 P.3d 1205 (N.M. App. 2015), another toxic tort case, the court, “[h]aving concluded that [plaintiff’s] arguments regarding . . . expert witness rulings provide no basis for reversal, . . . further conclude[d] that the court properly granted summary judgment in favor of Defendants.”  Id. at 1215.  Likewise, Farris v. Intel Corp., 493 F. Supp.2d 1174 (D.N.M. 2007), held:

General causation and specific causation are essential elements of Plaintiff’s 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.

Id. at 1186 (citation omitted).  Similarly, in R.R. v. Dandade, 2017 WL 2117386 (N.M. App. April 25, 2017), plaintiff had no expert to establish the relevant injury was drug related.  Thus, “[t]he district court properly granted summary judgment” because “a determination of the external cause of a patient’s condition requires specialized, scientific knowledge regarding those external agents involved.”  Id. at *6 (citation omitted).  See Derrick v. Standard Nutrition Co., 2019 WL 2024960, at *7 (D.N.M. May 8, 2019) (“Such medical knowledge is, as a matter of law, outside the realm of common experience.  Because Plaintiffs have not secured expert testimony on causation, they cannot withstand Defendant’s motion for summary judgment.”).

New York

The New York Court of Appeals was one of the first courts to articulate the modern requirement for expert testimony in tort cases in Meiselman v. Crown Heights Hospital:

[E]xpert medical opinion evidence . . . is required, when the subject-matter to be inquired about is presumed not to be within common knowledge and experience and when legal inference predominates over statement of fact . . .; but where the matters are within the experience and observation of the ordinary jurymen from which they may draw their own conclusions and the facts are of such a nature as to require no special knowledge or skill, the opinion of experts is unnecessary.

34 N.E.2d 367, 370 (N.Y. 1941).  See Fiore v. Galang, 478 N.E.2d 188, 189 (N.Y. 1985)  (error under Meiselman not to grant summary judgment because “expert medical opinion evidence is required to demonstrate merit” ).

Thus, in New York, “to establish causation, [Plaintiffs] must offer admissible expert testimony regarding both general causation . . . and specific causation.”  Amorgianos v. National Railroad Passenger Corp., 303 F.3d 256, 268 (2d Cir. 2002) (applying New York law).  It is a “well-established requirement that an expert opinion on causation set forth a plaintiff’s exposure to a toxin, that the toxin is capable of causing the particular illness (general causation) and that plaintiff was exposed to sufficient levels of the toxin to cause the illness (specific causation).”  In re New York City Asbestos Litigation, 11 N.Y.S.3d 416, 426 (N.Y. Sup. 2015).  See Fitzpatrick v. Currie, 861 N.Y.S.2d 431, 434 (N.Y. App. Div. 2008) (“While the opinion of an expert may not always be necessary in establishing a products liability case, the complex issues involved in the design and operation of [this product] make expert proof imperative.”); Marazzo v. Gilbert, 542 N.Y.S.2d 793, 794 (N.Y. App. Div. 1989) (“It was incumbent upon the plaintiff to elicit expert medical testimony . . . and, in the absence of such testimony on the issue of causation, the claim was properly dismissed”); Glowczenski v. Taser International, Inc., 594 F. Appx. 723, 725 (2d Cir. 2014) (“absent an expert . . . [plaintiffs] cannot prevail on either their products liability or wrongful death claims” because plaintiffs’ “tort claims against [defendant] fail for want of evidence on causation”) (applying New York law); Alaimo v. 3M Co., 306 F. Appx. 704 (2d Cir. 2009) (plaintiffs “were required to prove a causal link between use of the [product] at issue and the injury . . . by use of expert testimony”) (applying New York law); Brooks v. Outboard Marine Corp., 234 F.3d 89, 92 (2d Cir. 2000) (“summary judgment was properly granted” where plaintiff’s expert was excluded; plaintiff “has no evidence in the record to support his [design defect] theory”) (applying New York law); Williams v. Coca Cola Co., 2018 WL 3069208, at *5 (N.D.N.Y. June 21, 2018) (“[g]iven plaintiff’s failure to offer any expert proof on the issue of general and/or specific causation, defendant’s motion for summary judgment is granted”); Young v. Southwest Airlines Co., 2017 WL 1247921, at *3 (E.D.N.Y. Feb. 3, 2017) (“the medical effect on the human system of the infliction of injuries is not generally within the sphere of the common knowledge of the lay person”); Jaquez v. Flores, 2016 WL 1267780, at *4 (S.D.N.Y. March 30, 2016) (“Plaintiffs are thus required to produce admissible expert medical evidence on causation in order to sustain their wrongful death claim. They have chosen not to do so.”); Mallozzi v. EcoSMART Technologies, Inc., 2013 WL 2415677, at *14 (E.D.N.Y. May 31, 2013) (“Without . . . expert testimony, plaintiff cannot establish that the product was the proximate cause of plaintiff’s injuries.”); Kennedy v. New York Presbyterian Hospital, 2011 WL 2847839, at *4 (S.D.N.Y. July 6, 2011) (summary judgment granted; “Plaintiff must − but did not − submit expert medical opinion supporting her theory of causation”).  Also, “Under New York law, a plaintiff seeking to establish a design defect is generally required to provide expert testimony as to the feasibility and efficacy of alternative designs.”  Cuntan v. Hitachi KOKI USA, Ltd., 2009 WL 3334364, at *6 (E.D.N.Y. Oct. 15, 2009) (collecting cases).  See Guarascio v. Drake Associates, Inc., 582 F. Supp.2d 459, 463 (S.D.N.Y. 2008) (same).

In prescription medical product cases, where the plaintiff “suffered a complex injury,” expert testimony was essential.

Implantation of the . . . device involved complicated surgery.  Additionally, the . . . device implanted in [plaintiff] was not one with which an ordinary person would come in contact.  The issue of causation in such a complicated medical case, therefore, was one beyond the sphere of the ordinary juryman and required expert testimony.

Fane v. Zimmer, Inc., 927 F.2d 124, 131 (2d Cir. 1991) (applying New York law).  See Sura v. Zimmer, Inc., 768 F. Appx. 58, 59 (2d Cir. 2019) (in medical device case, “determining the cause of these symptoms is beyond the experience and observation of the ordinary jury, [plaintiff] needed expert testimony”); N.K. v. Abbott Laboratories, 731 F. Appx. 24, 27 (2d Cir. 2018) (“New York law requires expert witnesses to establish specific causation.”) (citing Meiselman); Tomaselli v. New York & Presbyterian Hospital, 728 F. Appx. 41, 43 (2d Cir. 2018) (following Fane in medical device case) (applying New York law); Donovan v. Centerpulse Spine Tech, Inc., 416 F. Appx. 104, 106 (2d Cir. 2011) (“ordinarily, expert medical opinion evidence is required, when the subject-matter to be inquired about is presumed not to be within common knowledge and experience”) (citation and quotation marks omitted) (applying New York law); Riegel v. Medtronic, Inc., 451 F.3d 104, 127 (2d Cir. 2006) (“because there was no competent evidence excluding [the defendant’s] proffered causes” of the plaintiffs’ injury after their expert was excluded, “there were no genuine issues of material fact for a jury on this claim”), aff’d, 552 U.S. 312 (2008); Washburn v. Merck & Co., 213 F.3d 627 (2d Cir. 2000) (affirming both expert exclusion and summary judgment) (applying New York law); Gidora v. Howmedica Osteonics Corp., 2019 WL 1129127, at *3 (S.D.N.Y. March 12, 2019) (“Where a claim raises complex issues requiring expert testimony to establish a fundamental element of the claim, summary judgment is appropriate if a plaintiff fails to produce a qualified expert or the plaintiff has been precluded from calling his or her proffered expert.”); Byrd v. Janssen Pharmaceuticals, Inc., 333 F. Supp.3d 111, 127-31 (N.D.N.Y. 2018) (judgment as a matter of law appropriate where plaintiff’s expert testimony failed to establish general causation); Adeghe v. Janssen Pharmaceuticals, Inc., 2018 WL 4112815, at *3 (S.D.N.Y. Aug. 29, 2018) (“because of the complex chemistry and biology involved in assessing the design of [the drug] and its alternatives, expert testimony is necessary”); Coleson v. Janssen Pharmaceutical, Inc., 251 F. Supp.3d 716, 723 (S.D.N.Y. 2017) (“Without competent medical expert testimony on the issue of causation, a jury would be left only to theorize as to how Plaintiff came to suffer from” his claimed injuries); Vargas v. Ortho-McNeil Pharmaceutical, Inc., 2013 WL 3776628, at *4 (N.D. Ohio July 17, 2013) (“It is clear that the determination of causation in this case requires the testimony of medical experts, which Plaintiff has repeatedly failed to provide.”) (applying New York law); In re Trasylol Products Liability Litigation, 2013 WL 1343529, at *13 (S.D. Fla. April 2, 2013) (after experts are excluded, all plaintiff’s claims “must fail”) (applying New York law); Dolphin v. Synthes (USA) Ltd., 2012 WL 13059723, at *3 (S.D.N.Y. Feb. 16, 2012) (“in cases that concern more complicated medical procedures, a jury cannot reasonably be expected to infer issues of causation and a medical expert is required”) (citing Fane); Maxwell v. Howmedica Osteonics Corp., 713 F. Supp.2d 84, 91 (N.D.N.Y. 2010) (“under New York law, a plaintiff seeking to establish a design defect is required to provide expert testimony as to the feasibility and efficacy of alternative designs”); Nealy v. U.S. Surgical Corp., 587 F. Supp.2d 579, 586 (S.D.N.Y. 2008) (“Expert medical opinion evidence is usually required to show the cause of an injury or disease because the medical effect on the human system of the infliction of injuries is generally not within the sphere of the common knowledge of the lay person.”); Rodriguez v. Mallinckrodt, Inc., 2007 WL 2811061, at *3 (E.D. Mo. Sept. 24, 2007) (“expert medical opinion evidence is required when the subject matter at issue is presumed to be beyond the common knowledge and experience of a jury”) (applying New York law), aff’d, 316 F. Appx. 527 (8th Cir. 2009); Prohaska v. Sofamor, S.N.C., 138 F. Supp.2d 422, 445 (W.D.N.Y. 2001) (“Absent competent medical expert testimony on the issue of causation, plaintiffs cannot prove the elements of a cause of action based in strict products liability or negligence.”); McLellan v. Sofamor-Danek Group, Inc., 1999 WL 222591, at *4 (W.D.N.Y. April 12, 1999) (“When competent medical opinion evidence is required, a judgment as a matter of law is appropriate if the plaintiff fails to adduce such.”) (citing Fane); Saari v. Merck & Co., 961 F. Supp. 387, 392 (N.D.N.Y. 1997) (“in a case such as this where there are complex medical issues, in order for plaintiff to prove that her alleged injuries were caused by defendants’ products, she must introduce expert medical testimony establishing causation”); Krasnopolsky v. Warner-Lambert Co., 799 F. Supp. 1342, 1348 (E.D.N.Y. 1992) (plaintiffs “have failed to submit any type of expert proof, in an affidavit or otherwise, which would establish any causation between [the] injury and the alleged negligence”); McGovern v. Davol, Inc., 2018 WL 1384549, at *7 (N.Y. Sup. March 15, 2018) (“Plaintiff fails to provide a medical expert who could opine that such a [product] defect was a substantial factor in causing Plaintiff’s injury”); Gentile v. Biogen Idec, Inc., 2016 WL 4168942, at *7 (Mass. Super. July 28, 2016) (“Because the adequacy of the warnings cannot be evaluated by a layperson, expert testimony is necessary to resolve the issue.”) (citation omitted) (applying New York law).

North Carolina

In North Carolina “cases involving 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.”  Holley v. ACTS, Inc., 581 S.E.2d 750, 753 (N.C. 2003).  See Click v. Pilot Freight Carriers, Inc., 265 S.E.2d 389, 391 (N.C. 1980) (same as to the “exact nature and probable genesis of a particular type of injury”).

Due to the complexities of medical science, particularly with respect to diagnosis, methodology and determinations of causation, this Court has held that where 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.

Young v. Hickory Business Furniture, 538 S.E.2d 912, 915 (N.C. 2000) (citations and quotation marks omitted).  See Campbell v. Duke University Health Systems, Inc., 691 S.E.2d 31, 36 (N.C. App. 2010) (same standards applicable to civil suits); Freeman v. Blue Ridge Paper Products, Inc., 529 F. Appx. 719, 725 (6th Cir. 2013) (“the subject matter of causation in this case is far removed from the ordinary person’s experience, and the matter more closely parallels those cases in which North Carolina courts require expert proof of causation”) (citation omitted) (applying North Carolina law); Free v. Baker, 469 F. Appx. 786, 791 (11th Cir. 2012) (“Expert testimony is required to establish medical causation under North Carolina law.”) (applying North Carolina law); Riggins v. SSC Yanceyville Operating Co., LLC, 2018 WL 4374929, at *3 (M.D.N.C. Sept. 13, 2018)  (“In North Carolina, not only does a plaintiff establish the standard of care with expert testimony, but medical experts are relied upon to show medical causation”) (citation and quotation marks omitted); Phillip v. GEO Group, Inc., 2012 WL 5392120, at *7 (E.D.N.C. Nov. 5, 2012) (“North Carolina courts have applied the requirement for expert medical testimony to actions in which a party claims to have been injured by an airborne toxin”), aff’d, 520 F. Appx. 215 (4th Cir. 2013) (on basis of district court opinion); Butler v. United States, 2011 WL 5191701, at *5 (Mag. M.D.N.C. Aug. 2, 2011) (“where the injury is complicated or unusual, a plaintiff must present expert witness testimony”), adopted, 2011 WL 5170015 (M.D.N.C. Oct. 31, 2011), aff’d, 702 F.3d 749 (4th Cir. 2012); Fontenot v. TASER International, Inc., 2011 WL 2535016, at *8 (W.D.N.C. June 27, 2011) (“In a complex product liability case such as this, a plaintiff must present expert medical testimony to establish causation.”).

Thus, “[i]n North Carolina, a jury award [in a products liability case] cannot be sustained in the absence of expert medical testimony on the issue of causation.”  Hensley v. Danek Medical, Inc., 32 F. Supp.2d 345, 350 (W.D.N.C. 1998).  “Without admissible expert testimony on the issue of specific causation, [plaintiff] cannot prove his claims under North Carolina law.”  In re Testosterone Replacement Therapy Products Liability Litigation Coordinated Pretrial Proceedings, 2017 WL 1833173, at *22 (N.D. Ill. May 8, 2017), reconsideration denied, 2017 WL 2953703 (N.D. Ill. July 11, 2017) (applying North Carolina law).  See Blackmon v. G.UB.MK Constructors, 2016 WL 8674646, at *3 (E.D.N.C. Nov. 11, 2016) (“Without competent expert testimony, evidence of causation remains mere speculation or conjecture and summary judgment in favor of the defendant is appropriate.”) (citation and quotation marks omitted); Ward v. Ortho-McNeil Pharmaceutical, 2015 WL 4110990, at *4 (E.D.N.C. July 7, 2015) (“in cases involving complicated medical questions . . ., only an expert can give competent opinion evidence as to the cause of the injury”) (citation and quotation marks omitted); Lipscomb v. Orkin, Inc., 2014 WL 3510117, at *2 (E.D.N.C. July 14, 2014) (“where a layman can have no well-founded knowledge and can do no more than indulge in mere speculation (as to the cause of a physical condition), there is no proper foundation for a finding by the trier without expert medical testimony”) (citation and quotation marks omitted); Doe v. Ortho-Clinical Diagnostics, Inc., 440 F. Supp.2d 465, 478 (M.D.N.C. 2006) (“Given the Court’s ruling above excluding . . . Plaintiffs’ sole expert on both general and specific causation, Plaintiffs cannot meet their burden of proof on the essential element of causation.”); Dunn v. Sandoz Pharmaceuticals Corp., 275 F. Supp.2d 672, 684 (M.D.N.C. 2003) (entering summary judgment after exclusion of expert left plaintiff unable to prove causation); Ward v. American Medical Systems, Inc., 170 F. Supp.2d 594, 599 (W.D.N.C. 2001) (“a plaintiff is obligated to come forward with expert medical opinion that his medical problems were caused by the defective product”), aff’d, 38 F. Appx. 909 (4th Cir. 2002); Baraukas v. Danek Medical, Inc., 2000 WL 223508, at *3 (M.D.N.C. Jan. 13, 2000) (“Given plaintiffs’ failure to present expert medical testimony on causation . . ., this Court finds that summary judgment for defendants is appropriate.”); Driggers v. Sofamor, S.N.C., 44 F. Supp.2d 760, 764-65 (M.D.N.C. 1998) (“where the injury is complicated, . . . expert medical testimony on the issue of causation must be provided to support a jury award”).

North Dakota

North Dakota cases hold that “expert testimony is required if the issue is beyond the area of common knowledge or lay comprehension, or the issue is not within the ordinary experience of the jurors.”  Klimple v. Bahl, 727 N.W.2d 256, 259 (N.D. 2007) (quoting Leno v. Ehli, 339 N.W.2d 92, 99 (N.D. 1983)).  “[W]hen the causal relationship between a condition affecting the human body and a [defendant’s conduct] is not a matter within the common knowledge or comprehension of a layperson, the party bearing the burden of proof must present expert medical testimony establishing that relationship.”  Halvorson v. Sentry Insurance, 757 N.W.2d 398, 400 (N.D. 2008).  “[A] technical procedure requir[es] an expert witness to establish . . . a causal relationship between the violation and the harm complained of.”  Cartwright v. Tong, 896 N.W.2d 638, 643 (N.D. 2017).

Thus, “[i]n a toxic tort case, a reasonable estimate of exposure by a reliable expert is often the only way a plaintiff can prove specific causation.”  Otto v. Newfield Exploration Co., 2016 WL 7439585, at *3 (D. Mont. Dec. 22, 2016) (applying North Dakota law).

Ohio

“Expert testimony is needed” in Ohio “on complex issues outside the area of common knowledge, such as an injury’s cause and effect.”  Lederer v. St. Rita’s Medical Center, 702 N.E.2d. 476, 483 (Ohio 1997).

“Except as to questions of cause and effect which are so apparent as to be matters of common knowledge, the issue of causal connection between an injury and a specific subsequent physical disability involves a scientific inquiry and must be established by the opinion of medical witnesses competent to express such opinion. . . .  Establishing general causation and specific causation in cases involving exposure to . . . toxic substances involves a scientific inquiry, and thus causation must be established by the testimony of a medical expert.

Terry v. Caputo, 875 N.E.2d 72, 77 (Ohio 2007) (citation and quotation marks omitted) (emphasis original).  See Richards v. Copes-Vulcan, Inc., ___ A.3d ___, 2019 WL 3282056, at *5 (Del. July 22, 2019) (“Under Ohio law, . . . expert medical evidence is required to support specific causation.”) (applying Ohio law).  “The development of a medical condition is typically not within the knowledge of a layperson, thus requiring a medical expert to establish causation of the medical condition.”  Lloyd v. Rogerson, 2019 WL 2721413, at *7 (Ohio App. June 28, 2019) (citation omitted).

In a toxic-tort case, as here, the plaintiff must establish both general and specific causation. . . .  Both causation inquiries involve scientific assessments that must be established through the testimony of a medical expert.  Without this testimony, a plaintiff’s toxic tort claim will fail.

Pluck v. BP Oil Pipeline Co., 640 F.3d 671, 676-77 (6th Cir. 2011) (applying Ohio law).  See Viars v. Ironton, 2016 WL 3670171, at *9 (Ohio App. July 6, 2016) (‘Expert testimony is required to establish general causation and specific causation in cases [where] . . . the determination involves a scientific inquiry into matters beyond the knowledge or experience possessed by lay persons”); Davie v. Nationwide Mutual Insurance Co., 2015 WL 179287, at *4 (Ohio App. Jan. 15, 2015) (“With [plaintiff] failing to offer expert testimony at trial on whether his soft tissue injuries were proximately caused by the tortfeasor’s negligence, the court had no choice but to direct a verdict.”); Bogner v. Titleist Club, L.L.C., 2006 WL 3825228, at *2 (Ohio App. Dec. 29, 2006) (“Expert testimony is needed on complex issues outside the area of the laypersons common knowledge, such as an injury’s cause and effect.”) (citations omitted); Alden v. Phifer Wire Products, Inc., 2005 WL 1407776, at *3 (Ohio App. June 16, 2005) (affirming summary judgment; following Valentine); Valentine v. PPG Industries, Inc., 821 N.E.2d 580, 588 (Ohio App. 2004) (affirming summary judgment because “[t]o prove the proximate cause of a medical condition . . . expert medical testimony ordinarily is necessary”), aff’d, 850 N.E.2d 683 (Ohio 2006); Prysock v. Bahner, 2004 WL 1445565, at *2 (Ohio App. June 29, 2004) (“[e]xpert medical testimony is necessary to show an injury’s cause and effect”); Thompson I.G., LLC v. Edgetech I.G. Inc., 590 F. Appx. 532, 538 (6th Cir. 2014) (“the causation issues here are too complex for the jury to decide without the help of expert testimony”) (applying Ohio law); Madej v. Maiden, 2018 WL 5045768, at *4 (S.D. Ohio Oct. 17, 2018) (“Without expert medical testimony on both general causation and specific causation, a plaintiff’s toxic tort claim will fail”) (quoting Baker); Baker v. Chevron USA, Inc., 680 F. Supp.2d 865, 874 (S.D. Ohio 2010) (following Terry), aff’d, 533 F. Appx. 509 (6th Cir. 2013); Davison v. Cole Sewell Corp., 2006 WL 2129803, at *5 (S.D. Ohio July 28, 2006) (granting summary judgment where plaintiff failed “to establish causation through expert opinion.”), aff’d, 231 F. Appx. 444 (6th Cir. 2007); Day v. NLO, 851 F. Supp. 869, 881 (S.D. Ohio 1994) (medical monitoring claim requires plaintiffs “to show by expert medical testimony that they have increased risk of disease”).

The same considerations control in product liability.  “Ohio law requires expert testimony where aspects of the defect or the proposed alternative designs are technically complex and outside the understanding of a lay juror.”  Newell Rubbermaid, Inc. v. Raymond Corp., 676 F.3d 521, 529 (6th Cir. 2012) (applying Ohio law).  Likewise, in Ohio, “[w]hen a plaintiff alleges that the warning given to a prescribing physician is inadequate, the plaintiff must prove his claim through expert medical testimony.”  Graham v. American Cyanamid Co., 350 F.3d 496, 514 (6th Cir. 2003) (applying Ohio law).  Further, “[u]nder Ohio law, a plaintiff must present expert medical testimony to establish causation when she asserts a specific physical injury, the cause for which is not within common knowledge.”  Botnick v. Zimmer, Inc., 484 F. Supp.2d 715, 724 (N.D. Ohio 2007).

[W]hether a prescription drug is defective and whether it is the proximate cause of an injury are questions which lie outside the knowledge of lay witnesses.  Accordingly, [plaintiff] would have to introduce expert testimony to establish these elements of her claim.

Kerpelis v. Pfizer, Inc., 2004 WL 1326771, at *5 (Ohio App. June 7, 2004).  See Jones v. Roche Laboratories, 616 N.E.2d 545, 548 (Ohio App. 1992) (“expert opinion evidence is necessary for that [inadequate warning] showing”); Taylor v. Medtronics, Inc., 861 F.2d 980, 987-88 (6th Cir. 1988) (affirming summary judgment entered after plaintiff’s expert stricken) (applying Ohio law); Parillo v. Lowe’s Home Centers, LLC, 2017 WL 4124585, at *1 (S.D. Ohio Sept. 18, 2017) (“lay witness opinions regarding the cause of complex medical conditions are . . . irrelevant in a product liability lawsuit”); Z.H. v. Abbott Laboratories, Inc., 2016 WL 5661582, at *4 (N.D. Ohio Sept. 30, 2016) (“Defendants would still be entitled to summary judgment on Plaintiffs’ defective design claim because Plaintiffs offered no expert testimony that [the drug’s] formulation’s risks outweigh its benefits.”); Schmiedebusch v. Mallinckrodt, Inc., 2011 WL 5362066, at *4 (Mag. N.D. Ohio Sept. 13, 2011) (“Under Ohio law, expert medical testimony is required to establish causation of a specific physical injury, if such cause is not within common knowledge.”), adopted, 2011 WL 5362061 (N.D. Ohio Oct. 31, 2011); Utz v. Howmedica Osteonics Corp., 2009 WL 5409046, at *10 (N.D. Ohio March 31, 2009) (“Plaintiffs have failed to proffer expert testimony or other evidence to support this design defect theory.  Accordingly, summary judgment is granted in Defendants’ favor on this claim.”); Saraney v. TAP Pharmaceutical Products, Inc., 2007 WL 148845, at *6 n.3 (N.D. Ohio Jan. 16, 2007) (“The lack of an expert witness proves fatal to [plaintiffs’] product defect claims”); Yanovich v. Sulzer Orthopedics, Inc., 2006 WL 3716812, at *6 (N.D. Ohio Dec. 14, 2006) (summary judgment “warranted on all of plaintiffs’ claims” where plaintiffs had no “expert medical evidence showing that [plaintiff] was injured as a proximate result of the defect” in medical device); Grant v. Memry Corp., 2006 WL 2794732, at *6 (N.D. Ohio Sept. 27, 2006) (“the workings of a [medical device] and the causal relationship between a malfunctioning [medical device] and [plaintiff’s] physical injury are beyond the knowledge and understanding of laypersons, and therefore expert evidence is necessary”); Harmon v. American Red Cross, 2003 WL 22999468, at *1 (N.D. Ohio Dec. 17, 2003)  (“neither [plaintiff’s medical condition] nor what causes that condition is a matter of common knowledge. That being so, plaintiff must provide expert testimony in order to prevail. She not having done so, defendant is entitled to summary judgment.”).

Oklahoma

Under Oklahoma law, “[w]hen an injury is of a nature requiring a skilled and professional person to determine cause and the extent thereof, the scientific question presented must necessarily be determined by testimony of skilled and professional persons.”  Christian v. Gray, 65 P.3d 591, 601-02 (Okla. 2003) (quoting Williams v. Safeway Stores, Inc., 515 P.2d 223, 227 (Okla. 1973)).  The cause of an illness “is a matter of medical science to be established by expert testimony.”  Ruland v. Zenith Construction, 283 P.2d 540, 541 (Okla. 1955)).

In product liability and toxic tort cases as well, “Oklahoma law generally requires expert testimony for complex issues of medical causation.”  Hall v. Conoco, Inc., 886 F.3d 1308, 1317 (10th Cir. 2018) (applying Oklahoma law).

Where, as here, the effect of a defect in a [product] on the human body involved complex medical and biomechanical questions that are beyond a jury’s ordinary knowledge and common experience, expert witness testimony was the best evidence of general causation.  Without such evidence, a jury would have to speculate whether a design defect in the [product] caused or exacerbated [plaintiff’s] injuries.  Such speculation would be error.

Nash v. General Motors Corp., 153 P.3d 73, 75 (Okla. Civ. App. 2007).  See Rodgers v. Beechcraft Corp., 759 F. Appx. 646, 679 (10th Cir. 2018) (“In the context of a complicated [product], Plaintiffs needed expert testimony to prove causation.”) (applying Oklahoma law); Ortiz v. Cooper Tire & Rubber Co., 2015 WL 1498713, at *3 (W.D. Okla. March 31, 2015) (summary judgment granted against warning claim for lack of expert testimony); Carver v. Kia Motors Corp., 2012 WL 119587, at *6 (N.D. Okla. Jan. 12, 2012). (“Without expert testimony . . ., the question of whether [plaintiff’s] injuries were caused by the alleged defect . . . is far too speculative to present to a jury.”).

The same is of course true in prescription medical product liability litigation.  “[U]nder Oklahoma law, a plaintiff must introduce expert testimony if the fact in issue is not within the realm of ordinary experience of mankind.”  Hollander v. Sandoz Pharmaceutical Corp., 289 F.3d 1193, 1214 (10th Cir. 2002) (citation and quotation marks omitted) (applying Oklahoma law).

[P]laintiff is claiming that a complex medical device was defective and she has not identified an expert who will testify in support of her claims.  Expert testimony is essential in cases “[w]here injuries are of a character requiring skilled and professional men to determine the cause and extent thereof.”  Plaintiff alleges that the Device . . . caused her to suffer pain and long term injury, and this is the type of claim that must be supported by expert testimony.

Stewart v. Sulzer Orthopedics, Inc., 2011 WL 2491593, at *4 (N.D. Okla. June 22, 2011) (quoting Alexander v. Smith & Nephew, P.L.C., 98 F. Supp.2d 1276, 1284 (N.D. Okla. 2000)).  See Manous v. Mylan Pharmaceuticals, Inc., 982 F. Supp.2d 1282, 1285 (W.D. Okla. 2013) (summary judgment granted; “there is simply no such expert testimony” about defect or causation); Shrum v. Novartis Pharmaceuticals Corp., 2013 WL 3326645, at *2 (W.D. Okla. June 28, 2013) (“to meet [plaintiff’s] burden of proof on case-specific causation, she must proffer expert testimony on the issue”); Delano v. Smith & Nephew, Inc., 2000 WL 689692, at *1 (Okla. Dist. May 12, 2000) (“A plaintiff must bridge the gap from the [device’s] mechanical behavior to plaintiff’s symptoms with reliable and relevant expert medical causation testimony.”) (citation and quotation marks omitted).

Oregon

In Oregon, “[i]f the issue turns upon some fact beyond the ken of laymen, expert testimony must be produced.”  State v. Davis, 261 P.3d 1197, 1209 n.11 (Or. 2011) (citation and quotation marks omitted).  The “settled rule” is that “where injuries complained of are of such character as to require skilled and professional persons to determine the cause and extent thereof, the question is one of science and must necessarily be determined by testimony of skilled, professional persons.”  Cleland v. Wilcox, 543 P.2d 1032, 1034 (Or. 1975) (quoting Uris v. Compensation Department, 427 P.2d 753, 755 (Or. 1967)).

When the element of causation involves a complex medical question, as a matter of law, no rational juror can find that a plaintiff has established causation unless the plaintiff has presented expert testimony that there is a reasonable medical probability that the alleged negligence caused the plaintiff’s injuries.  The rule prevents jurors from speculating about causation in cases where that determination requires expertise beyond the knowledge and experience of an ordinary lay person.

Pinkerton v. Tri-County Metropolitan Service Dist., 125 P.3d 840, 843 (Or. App. 2005) (citations and quotation marks omitted).  “[W]hether plaintiff was required to present expert testimony “ is “a question of law.”  Vandermay v. Clayton, 984 P.2d 272, 277 (Or. 1999).

“This rule is frequently invoked in negligence cases involving medical causation.”  PacifiCorp v. Northwest Pipeline GP, 879 F. Supp.2d 1171, 1200 (D. Or. 2012).  See Thorson v. Bend Memorial Clinic, 419 P.3d 756, 759 (Or. App. 2018) (plaintiff lacked “the necessary expert testimony in order to avoid summary judgment”); Joshi v. Providence Health Systems Corp., 108 P.3d 1195, 1196 (Or. App. 2005), (“when causation involves a complex medical question, evidence is insufficient to go to the jury without expert testimony”), aff’d, 149 P.3d 1164 (Or. 2006); Chouinard v. Health Ventures, 39 P.3d 951, 954 (Or. App. 2002)  (in case involving “tumors and their effects on the body . . . the issue of causation was a complex medical question that required expert testimony”); Cook v. United Airlines, Inc., 379 F. Appx. 554, 555 (9th Cir. 2010) (“[u]nder Oregon law, [plaintiff] was required to present some expert evidence” of causation) (applying Oregon law).

Similarly, product liability and toxic tort cases require expert testimony on various issues to establish a plaintiff’s prima facie case.  “Under Oregon law, when the element of causation involves a complex medical question, a plaintiff must present expert testimony that there is a reasonable medical probability of causation.”  Phelps v. Wyeth, Inc., 938 F. Supp.2d 1055, 1068 (D. Or. 2013) (citation omitted).

[P]laintiffs must present evidence of both general and specific causation to prevail on their claims. . . .  Thus, plaintiffs must present expert testimony to show by a preponderance of the evidence that [use of the device] can and did cause plaintiffs’ [injury].

McClellan v. I-Flow Corp., 710 F. Supp.2d 1092, 1098 (D. Or. 2010).  See McDowell v. Allied Building Products Corp., 230 P.3d 552, 557 (Or. App. 2010) (affirming dismissal of asbestos case when plaintiff did not produce “prima facie expert proof of causation”); Teater v. Pfizer, Inc., 2013 WL 2455995, at *5 (D. Or. June 6, 2013) (“When, as here, “the element of causation involves a complex medical question, as a matter of law, no rational juror can find that a plaintiff has established causation unless the plaintiff has presented expert testimony. . . that the actions complained of caused the plaintiff’s injuries.”) (citation and quotation marks omitted) (emphasis original); Lusch v. Matrixx Initiatives, Inc., 2007 WL 2816203, at *7 (D. Or. Sept. 25, 2007) (“without expert testimony, plaintiff is similarly unable to create a genuine issue of material fact as to causation”); Rietcheck v. City of Arlington, 2006 WL 1371650, at *3 (D. Or. May 15, 2006) (“[t]he issue of causation concerning exposure to hazardous substances . . . involves a complex medical question” requiring expert testimony).

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

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

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

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

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

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

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

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

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

Id. at 5. (citations omitted).

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

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

Id. at 6 (citations omitted).

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

*          *          *          *

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

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

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

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

PART ONE

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

Alabama

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

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

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

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

Alaska

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

Arizona

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

Arkansas

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

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

California

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

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

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

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

Colorado

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

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

Connecticut

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

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

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

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

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

Delaware

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

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

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

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

District of Columbia

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

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

First Nations

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

Florida

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

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

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

Georgia

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

Product liability claims fall into the same category.

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

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

Hawai’i

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

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

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

Idaho

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

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

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

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

Illinois

Illinois law holds:

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

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

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

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

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

Indiana

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

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

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

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

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

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

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

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

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

Iowa

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

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

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

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

Kansas

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

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

Kentucky

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

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

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

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

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

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

Louisiana

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

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

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

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

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

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

Maine

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

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

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

Maritime

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

    Background

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

    Removal/Remand

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

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

    Preemption

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

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

    Failure to Report

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

    Manufacturing Defect

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

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

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