Prescription Medical Product Causation – Expert Required – Part Two

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...