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Recently we discussed the latest opinion in the ongoing “controversy” over the application of Pennsylvania’s comment k across-the-board rule to cases involving medical devices.  Douglas v. Atrium Medical Corp., 2024 WL 4364950 (M.D. Pa. Sept. 20, 2024).  We use “controversy” advisedly, because as Douglas held, there is “no substantial ground for difference of opinion as to whether plaintiffs’ strict liability claims should be dismissed” under controlling Pennsylvania law.  Id. at *4.  As we discussed at length here, no less than eight Pennsylvania Supreme Court decisions since 1942 have unanimously rejected various attempts to impose strict liability of one form or another in prescription medical product liability litigation.

  • Henderson v. National Drug Co., 23 A.2d 743. 748 (Pa. 1942) (rejecting an “ex contractu” warranty-type liability in action against a drug manufacturer).
  • DiBelardino v. Lemmon Pharmacal Co., 208 A.2d 283, 283 (Pa. 1965) (rejecting implied warranty of merchantability against a drug manufacturer).
  • Incollingo v. Ewing, 282 A.2d 206, 219-20 (Pa. 1971) (rejecting §402A strict liability in action against a drug manufacturer under Restatement (Second) of Torts §402A, comment k (1965), and allowing solely negligence claims).
  • Baldino v. Castagna, 478 A.2d 807, 810 (Pa. 1984) (reiterating Incollingo).
  • Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1384 (Pa. 1991) (rejecting “strict liability independent of the issue of inadequate warning” in action against a drug manufacturer).
  • Cafazzo v. Central Medical Health Services, Inc., 668 A.2d 521, 527 (Pa. 1995) (rejecting intermediate seller/marketer strict liability in action against a medical device manufacturer).
  • Hahn v. Richter, 673 A.2d 888, 891 (Pa. 1996) (reaffirming Incollingo in action against a drug manufacturer).
  • Lance v. Wyeth, 85 A.3d 434,446 (Pa. 2014) (reiterating “this Court’s adoption of comment k in the strict-liability setting” in action against a drug manufacturer).

As if anything more were needed, Pennsylvania’s intermediate appellate court has also weighed in on this issue three times:

  • Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 523 A.2d 374, 377-78 (Pa. Super. 1987) (rejecting implied warranty of merchantability in action against a drug manufacturer).
  • Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. 2006) (applying Hahn and Incollingo broad application of comment k in in action against a medical device manufacturer).
  • Daniel v. Wyeth Pharmaceuticals, Inc., 15 A.3d 909 (Pa. Super. 2011) (following Hahn, et al. in action against a drug manufacturer).

However, after Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014), plaintiffs have mounted an attack – in federal court, mostly, which is contrary to Erie principles – on 80+ years of Pennsylvania rejection of strict liability in any form in prescription medical product liability litigation.  They’ve done so by standing on its head the Tincher court’s acknowledgement of Hahn as an exception to a general “presumption . . . that strict liability may be available with respect to any product.”  104 A.3d at 382 (“but see” citation to Hahn).

Plaintiffs tease some sort of implied criticism of Hahn from that dictumTincher involved pipe, not any sort of prescription medical product – and use it as an excuse to ignore all pre-Tincher precedent.  That’s a blatant heads-you-lose-tails-I-win argument, since Tincher retained §402A as the basis for Pennsylvania strict liability, 104 A.3d at 399, of which comment k is a part.  Had Tincher adopted the Third Restatement, plaintiffs surely would have taken that as a rejection of comment k as an aspect of § 402A.

Beyond using Tincher as an excuse to ignore the eight prior Pennsylvania Supreme Court rejections of strict liability in prescription medical product liability litigation, plaintiffs have also misrepresented the Superior Court’s directly-on-point Creazzo decision as supposedly the product of poor advocacy by a pro se appellant plaintiff.  That was a lie.  West Publishing made a mistake in the listing of counsel because the lawyer representing the Creazzo plaintiffs-appellants was a relative with the same name.  We thoroughly debunked that misrepresentation in this blogpost, and the Creazzo online opinion has been corrected.  A search of the Creazzo opinion (on Lexis or Westlaw) for “pro se” now produces nothing.

But the plaintiffs’ misinformation campaign successfully hoodwinked four federal judges, three of whom repeated that lie in published opinions.

  • Spear v. Atrium Medical Corp., 621 F. Supp.3d 553, 556 (E.D. Pa. 2022) (“Courts that have not barred strict liability have noted that Creazzo was argued by pro se plaintiffs and therefore unpersuasive”) (Hon. Gerald McHugh).
  • Gross v. Coloplast Corp., 434 F. Supp.3d 245, 250 (E.D. Pa. 2020) (“[t]he pro se plaintiffs in Creazzo do not appear to have litigated the point thoroughly”) (Hon. Michael Baylson).
  • Moultrie v. Coloplast Corp., 2020 WL 1249354, at *9 (Mag. W.D. Pa. March 16, 2020) (describing Schrecengost as “noting that the pro se plaintiffs in Creazzo did not offer a different interpretation”) (Hon. Patricia Dodge).
  • Schrecengost v. Coloplast Corp., 425 F. Supp.3d 448, 465 (W.D. Pa. 2019) (“[T]he Pennsylvania Supreme Court would likely decline to adopt Creazzo’s rationale. . . .  There is no indication that the parties presented a full and balanced record of policy considerations to the court in Creazzo.  In fact, the opposite was true. The court acknowledged that the appellants, who were pro se, offered no analysis or authority for a different interpretation of Hahn”) (Hon. Kim Gibson).

Unfortunately, while the underlying basis of the phony p-side arguments made to these four federal judges has been corrected in Creazzo itself, those four decisions remain on the books – the fruit of a poisonous tree.  Schrecengost has been cited in ten Pennsylvania cases that also mention “comment k” (including by Gross and Moultrie).  Moultrie (which is the only one of the four that is unpublished) has been cited in four Pennsylvania cases that also mention “comment k.”  Gross has been cited in nine Pennsylvania cases that also mention “comment k” (including Moultrie).  Spear has been cited in three Pennsylvania cases that also mention “comment k.”

So here is the list of federal cases that were indirectly influenced by the plaintiffs’ misrepresentation campaign concerning Creazzo

  • Ebert v. C.R. Bard, Inc., 2021 WL 2656690, at *5 (3d Cir. June 24, 2021) (citing Schrecengost and Gross).
  • In re Philips Recalled CPAP, Bi-Level PAP, & Ventilator Products Litigation, 2024 WL 278641, at *9 (W.D. Pa. Jan. 24, 2024) (citing Moultrie).
  • In re Philips Recalled CPAP, Bi-Level PAP, & Ventilator Products Litigation, 2023 WL 7019287, at *54 (W.D. Pa. Sept. 28, 2023) (citing Spear).
  • Cohen v. Johnson & Johnson, 634 F. Supp.3d 216, 227-28 (W.D. Pa. 2022) (citing Schrecengost and Moultrie).
  • Maietta v. C.R. Bard, Inc., 2022 WL 3577374, at *4-6 (E.D. Pa. Aug. 19, 2022) (citing Schrecengost, Gross, and Spear).
  • Ebert v. C.R. Bard, Inc., 459 F. Supp.3d 637, 647-53 (E.D. Pa. 2020) (citing Schrecengost, Gross, and Moultrie).
  • Patchcoski v. W.L. Gore & Associates, Inc., 2020 WL 4335016, at *6-7, 11 (M.D. Pa. July 28, 2020) (citing Schrecengost, Gross, and Moultrie)

Thus, it is evident that several other cases, particularly Maietta, Ebert, and Patchcoski, are also fruit of the poisonous tree, since they cite multiple cases in which the judges deciding them had been bamboozled by lies from the plaintiffs’ side that attacked the directly on point Creazzo decision.

We strongly encourage defendants in Pennsylvania prescription medical product liability litigation who are faced with similar attempts to assert strict liability claims to explain to the courts that much of the decisional law that their opponents cite is – directly or indirectly – based on lies about Creazzo.  Don’t let plaintiffs get away with this deception.

Finally, we also strongly recommend that medical device manufacturers, in particular, faced with strict liability claims in Pennsylvania also rely upon the Pennsylvania Supreme Court’s decision in Cafazzo, 668 A.2d 521.  Cafazzo is a device case.  While it is somewhat farther afield in context, as the plaintiffs were asserting strict liability claims against health care providers as supposed intermediate sellers, it applies the same principles that the Pennsylvania high court has used in other cases to preclude assertion of strict liability, and does so in a case involving medical devices.  It is certainly much more on point than Tincher, which did not involve prescription medical products at all.