Beginning with our complete put up lambasting Schrecengost v. Coloplast Corp., 425 F. Supp.3d 448 (W.D. Pa. Dec. 2, 2019), for ignoring 75 years of hitherto unbroken Pennsylvania precedent and permitting “strict legal responsibility” design defect declare in opposition to an FDA-regulated prescription medical product, we now have each chronicled and opposed the opposite facet’s try to infiltrate strict legal responsibility into Pennsylvania litigation involving such merchandise (primarily medical units). That try disregards seven Pennsylvania Supreme Court docket choices between 1948 (Henderson) and 2014 (Lance), in addition to the Pennsylvania Superior Court docket (an intermediate appellate court docket in Pennsylvania) (Creazzo), all rejecting utility of strict legal responsibility rules to prescription medical merchandise. For the gory particulars, see the prior put up.
As we mentioned in one other put up a pair years later, that assault on present Pennsylvania product legal responsibility is constant. Fortuitously, most choices have continued to respect Pennsylvania legislation as determined by the Pennsylvania appellate courts. Right here, are some newer ones, since 2021, that reject strict legal responsibility design defect claims in Pennsylvania prescription medical product instances: Dicair v. Gilead Sciences, Inc., 2022 WL 2703611, at *3-4 (E.D. Pa. July 12, 2022); Bostic v. Ethicon, Inc., 2022 WL 952129, at *8-9 (E.D. Pa. March 29, 2022); Brown v. C.R. Bard, Inc., 2022 WL 420914, at *4 & n.7 (E.D. Pa. Feb. 11, 2022); McDonnell v. Flowonix Medical, Inc., 2022 WL 221612, at *5 (E.D. Pa. Jan. 25, 2022); Ramos-Soto v. C.R. Bard, Inc., 2022 WL 1056581 at *1 n.i (E.D. Pa. Jan. 14, 2022); McGrain v. C.R. Bard, Inc., 551 F. Supp.3d 529, 535-36 (E.D. Pa. 2021); Mikula v. C.R. Bard, Inc., 2021 WL 5989130, at *4-5 (W.D. Pa. Dec. 17, 2021); Drumheller v. Johnson & Johnson, 2021 WL 1853407, at *10-11 (E.D. Pa. Might 10, 2021).
In 2021, as we additionally mentioned, the Third Circuit licensed the underlying query to the Pennsylvania Supreme Court docket in Ebert v. C.R. Bard, Inc., 2021 WL 2656690 (3d Cir. June 24, 2021). That court docket accepted the query, Ebert v. C.R. Bard, Inc., 260 A.3d 81 (Pa. 2021) (per curiam), however that case settled – so the guerrilla warfare within the federal district courts continues.
Chances are you’ll surprise, why would the opposite facet pushing so laborious for “strict legal responsibility” in design defect claims when equal claims might be introduced below a negligence idea? It’s not like plaintiffs in prescription medical product legal responsibility litigation want strict legal responsibility to keep away from issues with comparative fault, since docs, not the plaintiffs, are normally the choice makers. So why do they care?
We defined that right here – it pertains to a peculiarly pro-plaintiff Pennsylvania evidentiary quirk left over from the Eighties. In contrast to virtually each state within the nation, since 1987, Pennsylvania legislation has prohibited defendants from introducing proof of their compliance with authorities and/or trade requirements in strict legal responsibility design defect instances – typically. E.g., Lewis v. Coffing Hoist Division, 528 A.2nd 590, 593-94 (Pa. 1987) (overhead crane); Sullivan v. Werner Co., 253 A.3d 730, 747-48 (Pa. Tremendous. 2021), attraction granted, 279 A.3d 1183 (Pa. 2022) (scaffold); Gaudio v. Ford Motor Co., 976 A.2nd 524, 543 (Pa. Tremendous. 2009) (automotive seatbelts).
If “strict legal responsibility” design defect claims are allowed below Pennsylvania legislation, the opposite facet hopes to make use of Lewis and its Pennsylvania progeny to argue that every one proof of a prescription medical product’s compliance with the FDCA and FDA rules is utterly inadmissible. Not solely that, since Lewis excluded compliance with trade, not governmental, requirements (the opposite above-cited instances prolong the exclusion to governmental requirements), the identical rule would preclude producers of prescription medical merchandise from counting on different requirements proof resembling medical society greatest practices.
The pitched battle to date has primarily been over whether or not the long-standing Pennsylvania rejection of strict legal responsibility in prescription medical product instances applies to medical units, in addition to prescribed drugs – since all however one of many related Pennsylvania Supreme Court docket choices (the exception being Cafazzo v. Central Medical Well being Providers, Inc., 668 A.2nd 521, 527 (Pa. 1995)) contain prescribed drugs.
However there’s a second line of protection that the protection facet, not less than in federal court docket, ought to apply: the Federal Guidelines of Proof, particularly the definition of related proof in Fed. R. Evid. 401 (“any tendency to make a reality kind of possible than it will be with out the proof”). When litigation proceeds in federal court docket, “federal courts are to use state substantive legislation and federal procedural legislation.” Hanna v. Plumer, 380 U.S. 460, 465 (1965). The federal guidelines “routinely appl[y] in all civil actions and proceedings in the USA district courts.” Shady Grove Orthopedic Assocs., P.A. v. Allstate Insurance coverage Co., 559 U.S. 393, 400 (2010). The identical is true of the Federal Guidelines of Proof particularly. See Fed. R. Evid. 1(a) (“These guidelines apply to proceedings in United States courts.”); Fed. R. Evid. 1101(a-b) (guidelines apply to all “civil instances and proceedings” introduced in “United States district courts”).
Within the Third Circuit, particularly, Kelly v. Crown Gear Co., 970 F.2nd 1273 (3d Cir. 1992), addressed whether or not one of many Federal Guidelines of Proof, Rule 407 regarding subsequent remedial measures, utilized in federal court docket the place the identical proof arguably is perhaps (it isn’t, see the following Duchess determination mentioned right here) admissible in state court docket below Pennsylvania proof guidelines. A claimed distinction in admissibility of proof didn’t change the “arguably procedural” nature of the Federal Guidelines of Proof, so Rule 407 “subsequently governs on this variety motion however Pennsylvania legislation on the contrary.” Id. at 1278.
Covell v. Bell Sports activities, Inc., 651 F.3d 357 (3d Cir. 2011) − higher identified for incorrectly predicting that Pennsylvania would swap from Restatement (Second) of Torts §402A (1965) to the Restatement (Third) of Torts, Merchandise Legal responsibility (1998) – additionally instantly addressed the contradiction between the Pennsylvania strict-liability exclusion of requirements compliance proof and Rule 401’s liberal “any tendency” relevance definition. In federal court docket, below the Federal Guidelines of Proof, requirements compliance proof was related, it doesn’t matter what the admissibility rule could also be in Pennsylvania state court docket:
The relevancy provisions of the Federal Guidelines of Proof management on this case as a result of they’re arguably procedural. Below the Federal Guidelines of Proof, “‘[r]elevant proof’ means proof having any tendency to make the existence of any reality that’s of consequence to the dedication of the motion extra possible or much less possible than it will be with out the proof,” Rule 401, and “[a]ll related proof is admissible. . . .
Making use of this normal, we conclude that proof of [defendant’s] compliance with the [federal regulatory] Commonplace was related to the jury’s inquiry as a result of it went to not less than two info of consequence [to a strict liability design defect].
651 F.3d at 366 (Kelly quotation omitted).
Thus, even in these courts, resembling Schrecengost, which have ignored each Erie rules and Pennsylvania appellate precedent to permit strict legal responsibility design defect claims in opposition to prescription medical merchandise, it mustn’t observe from “strict legal responsibility” that the state-court exclusionary rule bars proof that the product complied with FDA requirements or that the related medical affiliation view the product because the “gold normal” (or one thing related). The federal guidelines of proof nonetheless apply in federal court docket, and still-binding evidentiary evaluation in Covell establishes that Federal Rule 401 this proof is related and subsequently admissible below Fed. R. Evid. 402.
Lastly, Pennsylvania did undertake a set of evidentiary guidelines in 1998, effectively after the Lewis determination. The Pennsylvania guidelines are related, and within the case of Pa. R. Evid. 401-402 equivalent, to the federal guidelines. The Pennsylvania guidelines didn’t embody the exclusionary rule in Lewis, nor has any subsequent Pennsylvania precedent mentioned the connection between Pa. R. Evid. 401 and the Lewis rule. Thus, this back-up evidentiary line of protection is way extra probably to achieve federal than in state court docket.
