United States: Prescription Medical Product Causation – Expert Required − Part Three

Last Updated: August 27 2019
Article by James Beck

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

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


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

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

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

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

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

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

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

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

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

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

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

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

Puerto Rico

The law in Puerto Rico holds that "a factfinder normally cannot find causation without the assistance of expert testimony to clarify complex medical and scientific issues that are more prevalent in medical malpractice cases than in standard negligence cases." Marcano Rivera v. Turabo Medical Center Partnership, 415 F.3d 162, 168 (1st Cir. 2005) (quoting Rojas-Ithier v. Sociedad Española de Auxilio Mutuo y Beneficiencia, 394 F.3d 40, 43 (1st Cir. 2005)) (applying Puerto Rico law). "[T]he decisive consideration in determining the necessity of expert opinion evidence is whether the subject of inquiry is one of such common knowledge that persons of ordinary education could reach a conclusion as intelligently as the witness or whether, on the other hand, the matter is sufficiently beyond common experience that the opinion of an expert is required." Collazo-Santiago v. Toyota Motor Corp., 937 F. Supp. 134, 140 (D.P.R. 1996) (citation and quotation marks omitted), aff'd, 149 F.3d 23 (1st Cir. 1998). See Velazquez v. Abbott Laboratories, 901 F. Supp.2d 279, 293 (D.P.R. 2012) (entering summary judgment on product liability claims because "plaintiffs have failed to introduce any expert testimony . . . to support their claims").

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

Rhode Island

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

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

South Carolina

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

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

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

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

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

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

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

South Dakota

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

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

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

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

Download >> Prescription Medical Product Causation – Expert Required − Part Three

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