Photo of Bexis

Starting with our comprehensive post lambasting Schrecengost v. Coloplast Corp., 425 F. Supp.3d 448 (W.D. Pa. 2019), for ignoring 75 years of hitherto unbroken Pennsylvania precedent and allowing a “strict liability” design defect claim against an FDA-regulated prescription medical product, we have both chronicled and opposed the other side’s attempt to infiltrate strict liability into Pennsylvania litigation involving such products (primarily medical devices). That attempt disregards seven Pennsylvania Supreme Court decisions between 1948 (Henderson) and 2014 (Lance), as well as the Pennsylvania Superior Court (an intermediate appellate court in Pennsylvania) (Creazzo), all rejecting application of strict liability principles to prescription medical products.  For the gory details, see the prior post.

As we discussed in another post a couple years later, that assault on existing Pennsylvania product liability is continuing.  Fortunately, most decisions have continued to respect Pennsylvania law as decided by the Pennsylvania appellate courts.  Here, are some more recent ones, since 2021, that reject strict liability design defect claims in Pennsylvania prescription medical product cases:  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. May 10, 2021).

In 2021, as we also discussed, the Third Circuit certified the underlying question to the Pennsylvania Supreme Court in Ebert v. C.R. Bard, Inc., 2021 WL 2656690 (3d Cir. June 24, 2021).  That court accepted the question, Ebert v. C.R. Bard, Inc., 260 A.3d 81 (Pa. 2021) (per curiam), but that case settled – so the guerrilla warfare in the federal district courts continues.

You may wonder, why would the other side pushing so hard for “strict liability” in design defect claims when equivalent claims can be brought under a negligence theory?  It’s not like plaintiffs in prescription medical product liability litigation need strict liability to avoid problems with comparative fault, since doctors, not the plaintiffs, are usually the decision makers.  So why do they care?

We explained that here – it relates to a peculiarly pro-plaintiff Pennsylvania evidentiary quirk left over from the 1980s.  Unlike almost every state in the country, since 1987, Pennsylvania law has prohibited defendants from introducing evidence of their compliance with government and/or industry standards in strict liability design defect cases – generally.  E.g., Lewis v. Coffing Hoist Division, 528 A.2d 590, 593-94 (Pa. 1987) (overhead crane); Sullivan v. Werner Co., 253 A.3d 730, 747-48 (Pa. Super. 2021), appeal granted, 279 A.3d 1183 (Pa. 2022) (scaffold); Gaudio v. Ford Motor Co., 976 A.2d 524, 543 (Pa. Super. 2009) (automotive seatbelts).

If “strict liability” design defect claims are allowed under Pennsylvania law, the other side hopes to use Lewis and its Pennsylvania progeny to argue that all evidence of a prescription medical product’s compliance with the FDCA and FDA regulations is completely inadmissible.  Not only that, since Lewis excluded compliance with industry, not governmental, standards (the other above-cited cases extend the exclusion to governmental standards), the same rule would preclude manufacturers of prescription medical products from relying on other standards evidence such as medical society best practices.

The pitched battle so far has primarily been over whether the long-standing Pennsylvania rejection of strict liability in prescription medical product cases applies to medical devices, as well as prescription drugs – since all but one of the relevant Pennsylvania Supreme Court decisions (the exception being Cafazzo v. Central Medical Health Services, Inc., 668 A.2d 521, 527 (Pa. 1995)) involve prescription drugs.

But there’s a second line of defense that the defense side, at least in federal court, should apply:  the Federal Rules of Evidence, specifically the definition of relevant evidence in Fed. R. Evid. 401 (“any tendency to make a fact more or less probable than it would be without the evidence”).  When litigation proceeds in federal court, “federal courts are to apply state substantive law and federal procedural law.”  Hanna v. Plumer, 380 U.S. 460, 465 (1965).  The federal rules “automatically appl[y] in all civil actions and proceedings in the United States district courts.”  Shady Grove Orthopedic Assocs., P.A. v. Allstate Insurance Co., 559 U.S. 393, 400 (2010).  The same is true of the Federal Rules of Evidence specifically.  See Fed. R. Evid. 1(a) (“These rules apply to proceedings in United States courts.”); Fed. R. Evid. 1101(a-b) (rules apply to all “civil cases and proceedings” brought in “United States district courts”).

In the Third Circuit, specifically, Kelly v. Crown Equipment Co., 970 F.2d 1273 (3d Cir. 1992), addressed whether one of the Federal Rules of Evidence, Rule 407 concerning subsequent remedial measures, applied in federal court where the same evidence arguably might be (it isn’t, see the subsequent Duchess decision discussed here) admissible in state court under Pennsylvania evidence rules.  A claimed difference in admissibility of evidence did not change the “arguably procedural” nature of the Federal Rules of Evidence, so Rule 407 “therefore governs in this diversity action notwithstanding Pennsylvania law to the contrary.”  Id. at 1278.

Covell v. Bell Sports, Inc., 651 F.3d 357 (3d Cir. 2011) − better known for incorrectly predicting that Pennsylvania would switch from Restatement (Second) of Torts §402A (1965) to the Restatement (Third) of Torts, Products Liability (1998) – also directly addressed the contradiction between the Pennsylvania strict-liability exclusion of standards compliance evidence and Rule 401’s liberal “any tendency” relevance definition.  In federal court, under the Federal Rules of Evidence, standards compliance evidence was relevant, no matter what the admissibility rule may be in Pennsylvania state court:

The relevancy provisions of the Federal Rules of Evidence control in this case because they are arguably procedural.  Under the Federal Rules of Evidence, “‘[r]elevant evidence’ means evidence having any tendency to make the existence of any fact that is of consequence to the determination of the action more probable or less probable than it would be without the evidence,” Rule 401, and “[a]ll relevant evidence is admissible. . . .

Applying this standard, we conclude that evidence of [defendant’s] compliance with the [federal regulatory] Standard was relevant to the jury’s inquiry because it went to at least two facts of consequence [to a strict liability design defect].

651 F.3d at 366 (Kelly citation omitted).

Thus, even in those courts, such as Schrecengost, that have ignored both Erie principles and Pennsylvania appellate precedent to allow strict liability design defect claims against prescription medical products, it should not follow from “strict liability” that the state-court exclusionary rule bars evidence that the product complied with FDA standards or that the relevant medical association view the product as the “gold standard” (or something similar).  The federal rules of evidence still apply in federal court, and still-binding evidentiary analysis in Covell establishes that Federal Rule 401 this evidence is relevant and therefore admissible under Fed. R. Evid. 402.

Finally, Pennsylvania did adopt a set of evidentiary rules in 1998, well after the Lewis decision.  The Pennsylvania rules are similar, and in the case of Pa. R. Evid. 401-402 identical, to the federal rules.  The Pennsylvania rules did not include the exclusionary rule in Lewis, nor has any subsequent Pennsylvania precedent discussed the relationship between Pa. R. Evid. 401 and the Lewis rule.  Thus, this back-up evidentiary line of defense is far more likely to succeed in federal than in state court.