Prescription Medical Product Causation – Expert Required – Part One

Author:Mr James Beck
Profession:Reed Smith

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 (Sertralinehydrochloride) Products Liability Litigation, 176 F. Supp.3d 483, 490 (E.D. Pa. 2016) ("Plaintiffs have not cited cases from any jurisdiction holding that the complex scientific question of whether a prescription drug is a teratogen can be answered without expert testimony or based on circumstantial evidence, and the legal principles upon which the Court has relied tend to be consistent across jurisdictions."), aff'd, 858 F.3d 787 (3d Cir. 2017); In re Bausch & Lomb, Inc. Contacts Lens Solution Products Liability Litigation, 693 F. Supp.2d 515, 518 (D.S.C. 2010) (Under the law of "all the applicable jurisdictions," "plaintiffs' claims cannot survive" after "plaintiffs' only general causation expert, has been excluded."), aff'd, 429 F. Appx. 249 (4th Cir. 2011); In re Rezulin Products Liability Litigation, 441 F. Supp.2d 567, 575 & n.68 (S.D.N.Y. 2006) (expert causation testimony in prescription medical product liability litigation "is a requirement in every state in which these plaintiffs have brought their claims"); In re Phenylpropanolamine (PPA) Products Liability Litigation, 2003 WL 27382559, at *1 (W.D. Wash. Oct. 24, 2003) ("Given the medically and scientifically complex nature of this litigation, expert testimony is crucial to the establishment of causation."); In re Norplant Contraceptive Products Liability Litigation, 215 F. Supp.2d 795, 830, 833 (E.D. Tex. 2002) ("[e]vidence of general causation must be provided in the form of expert testimony"; summary judgment granted; "Plaintiffs have not produced a shred of evidence or expert testimony that supports an association between Norplant and any of the [more than 950] exotic conditions").


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


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

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

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

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

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