You’ll have to excuse us a bit today.  This post is about product liability – specifically Pennsylvania product liability.  However, it is not really focused on prescription medical products.  But what can we say?  We were provoked.

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“The dark side of the Force is a pathway to many abilities some consider to be unnatural.”   – Darth Sidious (a/k/a Sheev Palpatine).

Money and the dark side share many of the same attributes.

The first footnote of a new law review article, Wertheimer & Rahdert, “The Force Awakens:  Tincher, Section 402A, & the Third Restatement in Pennsylvania,” 27 Widener Com. L.R. 157 (2018), reveals that “[t]he preparation of this article was supported in part by a research grant from the Pennsylvania Association for Justice.”  Id. at 157 n.1.  So we were not surprised in the least that “Force Awakens” read like a plaintiff litigation expert’s opinion on Pennsylvania product liability law.  The scholarship was bought and paid for, after all.

Another conclusion we reached by the end of that article was more surprising.

The Pennsylvania Association for Justice wuz robbed.  Whatever they paid, they didn’t get what they paid for.

To explain. “Force Awakens” was an obvious response to our own Bexis’ 2017 91-page opus, J. Beck, “Rebooting Pennsylvania Product Liability Law: Tincher v. Omega Flex & the End of Azzarello Super-Strict Liability,” 26(2) Widener L.J. 91 (2017).  As the PAJ engagement no doubt required, Bexis article and the propositions it contains come in for criticism.  “Rebooting,” 26(2) Widener L.J. at 204-05.  Heck, “Force Awakens” was even published in the same law review (albeit with an intervening name change) as Bexis’ article.  The point-counterpoint can hardly be more obvious.

Except Bexis didn’t get any research grants.

The first way that “Force Awakens” doesn’t stack up is simply size.  Size matters if an article is going to cover all the bases.  If the 91 pages of Bexis’ article were kilos, it would weigh in as a heavyweight.  This 57-page counter-punch is, comparatively, a featherweight.

Of course, in scholarship, length is something, but not everything.

So what else?  We think “Force Awakens” wastes precious pages discussing non-Pennsylvania law.  Granted that, given Tincher’s discussion of California precedent, see “Rebooting,” 26(2) Widener L.J. at 144-45, 163-64, 169-70, reference to California law makes sense, but the extended discussion of New Jersey law, “Force Awakens,” 27 Widener Com. L.R. at 164-65, seems odd and tangential, at best.

But most of “Force Awakens” was predictable – intended to provide something that plaintiffs could cite for arguments that Tincher didn’t change much, and (probably more importantly) in support of the embattled post-Tincher suggested jury instructions critiqued in “Rebooting.”  Thus, much of “Force Awakens” is an apologia for the SSJI and (like an expert report) reflects the position of those who purchased the scholarship:

  • “The Tincher court chose to maintain strict liability, and once again it crystallized that choice by reaffirming Section 402A, while at the same time refusing to adopt the directives of the Third Restatement.”  27 Widener Com. L.R. at 193.
  • “[P]roduct liability in Pennsylvania remains a form of strict liability.”  Id. at 194.
  • “Under Tincher the ‘blackletter’ principles of section 402A clearly remain the baseline for Pennsylvania product liability law.”  Id. at 196-97.
  • “[W]here a plaintiff succeeds in proving that a product’s dangers exceed ascertainable consumer expectations, social cost-benefit balancing of risks and utilities is not required.”  Id. at 198.
  • “Pennsylvania courts can and should utilize Barker’s fairly detailed discussion of the relevant evidentiary considerations as a guide.”  Id. at 200.
  • Tincher’s explication of risk-utility analysis carefully avoids dependence on proof of a reasonable or feasible alternative design.”  Id. at 201.
  • “The [SSJI] Subcommittee sought to change instructions that were directly in conflict with Tincher, but to leave in place all other instructions. . . . This approach strikes us as essentially correct.”  Id. at 204.
  • “[T]hirteen of fifteen distinct charges or parts of [the PDI] charges employ the phrase “unreasonably dangerous” at least once”; “its ubiquity in the proposed PDI instructions strikes us as revealing overkill.”  Id. at 204 n.165.
  • “[W]e believe that the fundamental doctrinal assumption on which these [defense side] criticisms rest is incorrect.”  Id. at 206.
  • “By reaffirming Pennsylvania’s commitment to . . . Section 402A, [Tincher] clearly signaled that product liability is and should remain . . . a doctrine firmly founded on strict liability.”  Id.
  • “Because Tincher reaffirmed the strict liability character of product liability, it remains necessary to keep product liability separate from negligence.”  Id. at 206-07.
  • “As the [SSJI] properly recognized, courts must continue to draw that dividing line in their jury instructions.”  Id. at 207.
  • “For purposes of product liability under Section 402A, a product contains relevant dangers if it ‘lacks any element that is necessary to make it safe’ for an intended or foreseeable use, or if it ‘contains a condition that makes it unsafe’ for such use.”  Id. at 208.
  • “[W]e agree with the [SSJI] Subcommittee that it would be both premature and inconsistent with Tincher’s overarching perspective to draft new warning instructions based on dicta in the opinion regarding that subject.”  Id. at 208-09.
  • “The critics’ argument that the standard jury instructions should embrace a ‘state of the art’ defense is in our opinion entirely incorrect. . . .  This is a due care defense, pure and simple, and it sounds in negligence.”  Id. at 210.
  • “The Subcommittee used Barker’s revised list on the ground that it enabled more streamlined and efficient instructions.  As a practical matter we agree with this assessment. More importantly, we think the charge that the Subcommittee ignored the relevance of the Wade factors is incorrect.”  Id. at 211.

Overall, we found “Force Awakens” recitation of these (and other) pro-plaintiff talking points quite superficial.  To take just one example, the state-of-the-art discussion utterly ignores prior Pennsylvania appellate authority recognizing that such a defense exists as to risk/utility analysis, Hicks v. Dana Cos., 984 A.2d 943, 966 (Pa. Super. 2009), and never comes to grips with the black letter of the consumer expectation test requiring plaintiffs to prove that relevant product risks are “unknowable.  Bexis covered all that in some detail.  See “Rebooting,” 26(2) Widener L.J. at 164-72 (discussing state of the art issues).

Also inexplicably absent from “Force Awakens” is the Pennsylvania Supreme Court’s treatment of the “unreasonably dangerous” of Restatement §402A in Tincher.  “[T]he notion of ‘defective condition unreasonably dangerous’ is the normative principle of the strict liability cause of action.”  Tincher v. Omega Flex, Inc., 104 A.3d 328, 400 (Pa. 2014).

[I]n a jurisdiction following the Second Restatement formulation of strict liability in tort, the critical inquiry in affixing liability is whether a product is “defective”; in the context of a strict liability claim, whether a product is defective depends upon whether that product is “unreasonably dangerous.”

Id. at 380.  The “normative” nature of the unreasonably dangerous element is nowhere found in “Force Awakens” (the word never appears), and its status as “the critical inquiry” is buried in a footnote, 27 Widener Com. L.R. at 183 n.94, while the article describes other issues as “critical.”  Id. at 183 (“defective condition”), 193 (same), 194 (failure to satisfy defect tests).  Unreasonably dangerous as “overkill”?  We don’t think so.

Assuming that “Force Awakens” is used as intended to counter defense-side arguments about Tincher, we’ve found that, on a close read, the article includes some useful concessions, should defendants need to reply:

  • “Trial courts clearly may no longer rely on the jury instructions that had emanated from Azzarello.”  27 Widener Com. L.R. at 193.
  • “The fact that a product may be dangerous . . . does not automatically mean that it is also defective.”  Id. at 195.
  • “The Tincher court acknowledged that Third Restatement materials sometimes may be helpful.”  Id. at 197.
  • Tincher recognized a negligence strand that contributed to product liability law’s formation and continues to play a role in its development.”  Id. at 206.
  • “[T]he ‘unreasonably dangerous’ language of Section 402A need not be excised in its entirety from product liability jury instructions,” id. at 207 − precisely what the pro-plaintiff SSJI did.
  • “[T]he general [SSJI] statement that ‘[a] product is defective’ if it lacks a necessary safety feature or contains an unsafe condition qualifies as an overstatement.”  Id. at 208.
  • Tincher “reaffirmed the default position that plaintiffs typically bear the burden of persuasion in civil matters.”  Id. at 212.
  • “The [SSJI] Subcommittee’s minimalist approach, while comporting with Tincher’s appeals to modesty and caution, ends up offering little by way of guidance on a range of potentially vexing product liability issues.”  Id. at 212-13.

We think that last quote is a particularly important point of departure. The SSJI subcommittee has always been slow, particularly when the law shifts in favor of defendants.  It took over 40 years, for example, for the Pennsylvania SSJIs to incorporate learned intermediary rule instructions.  As “Force Awakens” concedes, after Tincher the subcommittee’s tendency hardened to the point of Azzarello-based ossification “offering little by way of guidance.”  Id. at 213.

We on the defense side take the opposite view − recognizing the need of the bench and bar to fill in some of these post-Tincher blanks.  In sharp contrast to the retrograde approach endorsed by “Force Awakens,” the defense side’s jury instructions are being expanded and updated.  The 2018 second edition, which has just been released to the public, not only incorporates the most recent post-Tincher precedent – including the Superior Court’s 2018 holding that giving an Azzarello strict liability instruction is now “a paradigm example of fundamental error,” Tincher v. Omega Flex, Inc., 180 A.3d 386, 399 (Pa. Super. 2018) – but also has expanded beyond strictly Tincher issues to include instructions on causation (3 different situations), component parts, and post-sale duty to warn.  Suggested instructions are just that, suggestions; only the defense believes in more, not less.

Finally, our mention of post-Tincher precedent in the preceding paragraph is at the heart of why we believe that PAJ didn’t get value for whatever it paid.  Tincher was decided in late 2014.  “Force Awakens” came out halfway through 2018 – 3 ½ years later.  Bexis’ “Rebooting” article collected and reviewed every post-Tincher decision right up until that article couldn’t be edited any longer.  “Force Awakens” is just the opposite.  Remarkably, it doesn’t cite a single post-Tincher Pennsylvania decision.  Not one.  That omission, we’re pleased (but surprised) to say, leaves our opponents without any precedential support – just a law review article ex cathedra.

If we had to speculate on the reason why “Force Awakens” went radio silent on Pennsylvania precedent, we would again analogize to a litigation expert report. The available data – here post-Tincher precedent – was not supportive of the positions that the authors were being paid to advocate.  So they did what other paid experts do:  ignore it.

So, where the other side goes silent, that’s a signal for us to pour it on.  Here’s our support for our contention that almost all post-Tincher decisions disagree with the positions being asserted in “Force Awakens.”

Rejecting argument that Tincher was a narrow decision that did not change anything

Tincher v. Omega Flex, Inc., 180 A.3d 386, 401-02 (Pa. Super. 2018) (“Tincher II”)

Renninger v. A&R Machine Shop, 163 A.3d 988, 1000 (Pa. Super. 2017)

Plaxe v. Fiegura, 2018 WL 2010025, at *6 (E.D. Pa. April 27, 2018)

After Tincher an Azzarello-“any element”/”guarantor” jury charge is reversible error

Tincher v. Omega Flex, Inc., 180 A.3d 386, 399-400 (Pa. Super. 2018) (“Tincher II”)

After Tincher courts need not be bound by Azzarello-era decisions

Renninger v. A&R Machine Shop, 163 A.3d 988, 1000 (Pa. Super. 2017)

Cloud v. Electrolux Home Products, Inc., 2017 WL 3835602, at *2 (E.D. Pa. Jan. 26, 2017)

Rapchak v. Haldex Brake Products Corp., 2016 WL 3752908, at *3 (W.D. Pa. July 14, 2016)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *7 (C.P. Clarion Co. Oct. 19, 2015)

Tincher requires that the product be “unreasonably dangerous”

Tincher v. Omega Flex, Inc., 180 A.3d 386, 401-02 (Pa. Super. 2018) (“Tincher II”)

High v. Pennsy Supply, Inc., 154 A.3d 341, 347 (Pa. Super. 2017)

Amato v. Bell & Gossett, Clark-Reliance Corp., 116 A.3d 607, 620 (Pa. Super. 2015), appeal dismissed, 150 A.3d 956 (Pa. 2016)

Sikkelee v. AVCO Corp., 268 F. Supp.3d 660, 696 (M.D. Pa. 2017)

Roudabush v. Roundo, Inc., 2017 WL 3912370, at *2 (W.D. Pa. Sept. 5, 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 450 (E.D. Pa. 2016)

DeJesus v. Knight Industries & Associates, Inc., 2016 WL 4702113, at *6-7 (E.D. Pa. Sept. 8, 2016)

Rapchak v. Haldex Brake Products Corp., 2016 WL 3752908, at *2 (W.D. Pa. July 14, 2016)

Stellar v. Allied Signal, Inc., 98 F. Supp.3d 790, 807 (E.D. Pa. 2015)

Nathan v. Techtronic Industries North America, Inc., 92 F. Supp.3d 264, 272 (M.D. Pa. 2015)

Punch v. Dollar Tree Stores, Inc., 2015 WL 7769223, at *3 (Mag. W.D. Pa. Nov. 5, 2015), adopted, 2015 WL 7776601 (W.D. Pa. Dec. 2, 2015)

Mattocks v. AVI Food Systems, Inc., 2015 WL 13701408, at *8 (Pa. C.P. Mercer Co. April 14, 2015)

Dunlap v. American Lafrance, LLC, 2016 WL 9340617, at *2 & n.4 (Pa. C.P. Allegheny Co. April 4, 2016)

Explicitly applying Wade factors/cost-benefit balancing

Sikkelee v. AVCO Corp., 268 F. Supp.3d 660, 695 (M.D. Pa. 2017)

Igwe v. Skaggs, 258 F. Supp.3d 596, 610 (W.D. Pa. 2017)

Punch v. Dollar Tree Stores, 2017 WL 752396, at *8 (Mag. W.D. Pa. Feb. 17, 2017), adopted, 2017 WL 1159735 (W.D. Pa. March 29, 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 451 (E.D. Pa. 2016)

Rapchak v. Haldex Brake Products Corp., 2016 WL 3752908, at *2-3 (W.D. Pa. July 14, 2016)

Rapchak v. Haldex Brake Products Corp., 2016 WL 1019534, at *13-14 & n.16 (W.D. Pa. March 15, 2016)

Lewis v. Lycoming, 2015 WL 3444220, at *3 (E.D. Pa. May 29, 2015)

Capece v. Hess Maschinenfabrik GmbH & Co. KG, 2015 WL 1291798, at *3 n.2, 7 (M.D. Pa. March 20, 2015)

Meyers v. LVD Acquisitions, LLC, 2016 WL 8652790, at *2 (Pa. C.P. Mifflin Co. Sept. 23, 2016), aff’d mem., 2017 WL 1163056 (Pa. Super. March 28, 2017)

High v. Pennsy Supply, Inc., 2016 WL 676409, at *2 (C.P. Dauphin Co. Feb. 18, 2016), rev’d on other grounds, 154 A.3d 341 (Pa. Super. 2017)

Mattocks v. AVI Food Systems, Inc., 2015 WL 13701408, at *9 (Pa. C.P. Mercer Co. April 14, 2015)

Renninger v. A&R Machine Shop, 2015 WL 13238603, at *5 (Pa. C.P. Clarion Co. Nov. 3, 2015), aff’d, 163 A.3d 988 (Pa. Super. 2017)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *4 (C.P. Clarion Co. Oct. 19, 2015)

Summary judgment for lack of viable alternative design in risk/utility case

Dunlap v. American Lafrance, LLC, 2016 WL 9340617, at *3 (Pa. C.P. Allegheny Co. April 4, 2016)

High v. Pennsy Supply, Inc., 2016 WL 676409, at *4 (C.P. Dauphin Co. Feb. 18, 2016), rev’d on other grounds, 154 A.3d 341 (Pa. Super. 2017)

Tincher does not shift risk/utility burden of proof

Capece v. Hess Maschinenfabrik GmbH & Co. KG, 2015 WL 1291798, at *3 n.1 (M.D. Pa. March 20, 2015)

Meyers v. LVD Acquisitions, LLC, 2016 WL 8652790, at *1 (Pa. C.P. Mifflin Co. Sept. 23, 2016), aff’d mem., 2017 WL 1163056 (Pa. Super. March 28, 2017)

Dunlap v. American Lafrance, LLC, 2016 WL 9340617, at *2 n.4 (Pa. C.P. Allegheny Co. April 4, 2016)

Tincher rejects blanket exclusion of “negligence concepts” in strict liability

Roverano v. John Crane, 177 A.3d 892, 907 n.9 (Pa. Super. 2017)

Renninger v. A&R Machine Shop, 163 A.3d 988, 997 (Pa. Super. 2017)

Webb v. Volvo Cars, LLC, 148 A.3d 473, 482-83 (Pa. Super. 2016)

Amato v. Bell & Gossett, Clark-Reliance Corp., 116 A.3d 607, 620 (Pa. Super. 2015), appeal dismissed, 150 A.3d 956 (Pa. 2016)

Mercurio v. Louisville Ladder, Inc., 2018 WL 2465181, at *7 (M.D. Pa. May 31, 2018)

Dodson v. Beijing Capital Tire Co., 2017 WL 4284417, at *6 (Mag. M.D. Pa. Sept. 27, 2017)

Cloud v. Electrolux Home Products, Inc., 2017 WL 3835602, at *2 (E.D. Pa. Jan. 26, 2017)

DeJesus v. Knight Industries & Associates, Inc., 2016 WL 4702113, at *6 (E.D. Pa. Sept. 8, 2016)

Rapchak v. Haldex Brake Products Corp., 2016 WL 3752908, at *2-3 (W.D. Pa. July 14, 2016)

Rapchak v. Haldex Brake Products Corp., 2016 WL 1019534, at *13 n.15 (W.D. Pa. March 15, 2016)

Punch v. Dollar Tree Stores, Inc., 2015 WL 7769223, at *7 (Mag. W.D. Pa. Nov. 5, 2015), adopted, 2015 WL 7776601 (W.D. Pa. Dec. 2, 2015)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *3-4 (C.P. Clarion Co. Oct. 19, 2015)

Risk/utility test is similar to, and derived from, negligence

Renninger v. A&R Machine Shop, 163 A.3d 988, 997 (Pa. Super. 2017)

Webb v. Volvo Cars, LLC, 148 A.3d 473, 482 (Pa. Super. 2016)

Dodson v. Beijing Capital Tire Co., 2017 WL 4284417, at *6 (Mag. M.D. Pa. Sept. 27, 2017)

Sikkelee v. AVCO Corp., 268 F. Supp.3d 660, 696 (M.D. Pa. 2017)

Punch v. Dollar Tree Stores, 2017 WL 752396, at *7 (Mag. W.D. Pa. Feb. 17, 2017), adopted, 2017 WL 1159735 (W.D. Pa. March 29, 2017)

Cloud v. Electrolux Home Products, Inc., 2017 WL 3835602, at *2 (E.D. Pa. Jan. 26, 2017)

DeJesus v. Knight Industries & Associates, Inc., 2016 WL 4702113, at *9 (E.D. Pa. Sept. 8, 2016)

Punch v. Dollar Tree Stores, Inc., 2015 WL 7769223, at *5 (Mag. W.D. Pa. Nov. 5, 2015), adopted, 2015 WL 7776601 (W.D. Pa. Dec. 2, 2015)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *3-4 (C.P. Clarion Co. Oct. 19, 2015)

Renninger v. A&R Machine Shop, 2015 WL 13238604, at *8 (Pa. C.P. Clarion Co. April 17, 2015)

Risk/utility test requires expert testimony

Hatcher v. SCM Group, Inc., 167 F. Supp.3d 719, 724-25 (E.D. Pa. 2016)

Meyers v. LVD Acquisitions, LLC, 2016 WL 8652790, at *2 (Pa. C.P. Mifflin Co. Sept. 23, 2016), aff’d mem., 2017 WL 1163056 (Pa. Super. March 28, 2017)

Dunlap v. American Lafrance, LLC, 2016 WL 9340617, at *3 (Pa. C.P. Allegheny Co. April 4, 2016) (risks of alternative design)

Renninger v. A&R Machine Shop, 2015 WL 13238604, at *4 (Pa. C.P. Clarion Co. April 17, 2015)

Tincher requires jury instruction on “unreasonably dangerous”

Tincher v. Omega Flex, Inc., 180 A.3d 386, 401-02 (Pa. Super. 2018) (“Tincher II”)

Amato v. Bell & Gossett, Clark-Reliance Corp., 116 A.3d 607, 620-21 (Pa. Super. 2015), appeal dismissed, 150 A.3d 956 (Pa. 2016)

Rejecting Azzarello guarantor/any element jury instruction

Tincher v. Omega Flex, Inc., 180 A.3d 386, 399-400 (Pa. Super. 2018) (“Tincher II”)

Renninger v. A&R Machine Shop, 2015 WL 13238603, at *3-4 (Pa. C.P. Clarion Co. Nov. 3, 2015), aff’d, 163 A.3d 988 (Pa. Super. 2017)

Consumer expectation test held inappropriate

Igwe v. Skaggs, 258 F. Supp.3d 596, 611 (W.D. Pa. 2017) (known risk)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 452-53 (E.D. Pa. 2016) (complexity)

DeJesus v. Knight Industries & Associates, Inc., 2016 WL 4702113, at *8-9 (E.D. Pa. Sept. 8, 2016)

Punch v. Dollar Tree Stores, Inc., 2015 WL 7769223, at *5 (Mag. W.D. Pa. Nov. 5, 2015), adopted, 2015 WL 7776601 (W.D. Pa. Dec. 2, 2015)

Capece v. Hess Maschinenfabrik GmbH & Co. KG, 2015 WL 1291798 (M.D. Pa. March 20, 2015) (conceded inappropriate to mechanical equipment – concrete block maker)

Meyers v. LVD Acquisitions, LLC, 2016 WL 8652790 (Pa. C.P. Mifflin Co. Sept. 23, 2016), aff’d mem., 2017 WL 1163056 (Pa. Super. March 28, 2017) (known risk)

Mattocks v. AVI Food Systems, Inc., 2015 WL 13701408, at *9 (Pa. C.P. Mercer Co. April 14, 2015) (obvious risk)

Consumer expectation test based on objective, reasonable consumer (not plaintiff)

High v. Pennsy Supply, Inc., 154 A.3d 341, 348-49 (Pa. Super. 2017)

Igwe v. Skaggs, 258 F. Supp.3d 596, 610 (W.D. Pa. 2017)

Yazdani v. BMW of North America, LLC, 188 F. Supp.3d 486, 493 (E.D. Pa. 2016)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 450-52 (E.D. Pa. 2016)

DeJesus v. Knight Industries & Associates, Inc., 2016 WL 4702113, at *7 (E.D. Pa. Sept. 8, 2016)

Bailey v. B.S. Quarries, Inc., 2016 WL 1271381, at *15 (M.D. Pa. March 31, 2016), appeal dismissed, 674 F. Appx. 149 (3d Cir. 2017)

Lewis v. Lycoming, 2015 WL 3444220, at *3 (E.D. Pa. May 29, 2015)

Meyers v. LVD Acquisitions, LLC, 2016 WL 8652790, at *2 (Pa. C.P. Mifflin Co. Sept. 23, 2016), aff’d mem., 2017 WL 1163056 (Pa. Super. March 28, 2017)

Strict liability only applies to a manufacturer’s own products

Sikkelee v. AVCO Corp., 268 F. Supp.3d 660, 712 (M.D. Pa. 2017)

McLaud v. Industrial Resources, Inc., 2016 WL 7048987, at *7 (M.D. Pa. Dec. 5, 2016), aff’d, 715 F. Appx. 115 (3d Cir. 2017)

Schwartz v. Abex Corp., 106 F. Supp.3d 626, 653-54 (E.D. Pa. 2015)

Tincher principles apply to warning claims

Amato v. Bell & Gossett, Clark-Reliance Corp., 116 A.3d 607, 620 (Pa. Super. 2015), appeal dismissed, 150 A.3d 956 (Pa. 2016)

Igwe v. Skaggs, 258 F. Supp.3d 596, 609-10 (W.D. Pa. 2017)

Bailey v. B.S. Quarries, Inc., 2016 WL 1271381, at *15 (M.D. Pa. March 31, 2016), appeal dismissed, 674 F. Appx. 149 (3d Cir. 2017)

Trask v. Olin Corp., 2016 WL 1255302, at *9 n.20 (W.D. Pa. March 31, 2016)

Williams v. U-Haul International, Inc., 2015 WL 171846, at *3 n.6 (E.D. Pa. Jan. 14, 2015) (subsequently vacated in part on other grounds having to do with negligence, 2015 WL 790142)

Horst v. Union Carbide Corp., 2016 WL 1670272, at *16 (Pa. C.P. Lackawanna Co. April 27, 2016)

Product must be “unreasonably dangerous” without a warning

High v. Pennsy Supply, Inc., 154 A.3d 341, 351 (Pa. Super. 2017)

Igwe v. Skaggs, 258 F. Supp.3d 596, 612, 614-15 (W.D. Pa. 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 453-54 (E.D. Pa. 2016)

Hatcher v. SCM Group, Inc., 167 F. Supp.3d 719, 725, 727 (E.D. Pa. 2016)

Inman v. General Electric Co., 2016 WL 5106939, at *7 (W.D. Pa. Sept. 20, 2016)

Post-sale duty to warn continues to require defect at sale

Trask v. Olin Corp., 2016 WL 1255302, at *9 (W.D. Pa. March 31, 2016)

Evidence of product user’s negligent conduct admissible as relevant to risk/utility

Punch v. Dollar Tree Stores, 2017 WL 752396, at *11 (Mag. W.D. Pa. Feb. 17, 2017), adopted, 2017 WL 1159735 (W.D. Pa. March 29, 2017)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *4 (C.P. Clarion Co. Oct. 19, 2015)

Evidence of third-party’s negligent conduct admissible as relevant to risk/utility

Dodson v. Beijing Capital Tire Co., 2017 WL 4284417, at *5-6 (Mag. M.D. Pa. Sept. 27, 2017)

Evidence of product user’s knowledge admissible as relevant to consumer expectation

Igwe v. Skaggs, 258 F. Supp.3d 596, 611-12 (W.D. Pa. 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 452 (E.D. Pa. 2016)

Evidence of product warnings relevant to consumer expectation

Igwe v. Skaggs, 258 F. Supp.3d 596, 610-11 (W.D. Pa. 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 452-53 (E.D. Pa. 2016)

Evidence of product user’s negligent conduct admissible as relevant to causation

Dodson v. Beijing Capital Tire Co., 2017 WL 4284417, at *5 (Mag. M.D. Pa. Sept. 27, 2017)

Wright v. Ryobi Technologies, Inc., 175 F. Supp.3d 439, 450 (E.D. Pa. 2016)

Evidence of a product’s compliance with industry standards is relevant/admissible

Webb v. Volvo Cars, LLC, 148 A.3d 473, 482-83 (Pa. Super. 2016) (maybe, but issue was not properly preserved)

Mercurio v. Louisville Ladder, Inc., 2018 WL 2465181, at *7 (M.D. Pa. May 31, 2018)

Cloud v. Electrolux Home Products, Inc., 2017 WL 3835602, at *1-2 (E.D. Pa. Jan. 26, 2017)

Rapchak v. Haldex Brake Products Corp., 2016 WL 3752908, at *3 (W.D. Pa. July 14, 2016)

Dunlap v. American Lafrance, LLC, 2016 WL 9340617, at *3 (Pa. C.P. Allegheny Co. April 4, 2016)

Renninger v. A&R Machine Shop, 2015 WL 13238603, at *2 (Pa. C.P. Clarion Co. Nov. 3, 2015), aff’d, 163 A.3d 988 (Pa. Super. 2017)

Sliker v. National Feeding Systems, Inc., 2015 WL 6735548, at *6-7 (C.P. Clarion Co. Oct. 19, 2015)

Renninger v. A&R Machine Shop, 2015 WL 13238604, at *8-9 (Pa. C.P. Clarion Co. April 17, 2015)

Evidence of compliance with government standards is relevant/admissible

Renninger v. A&R Machine Shop, 2015 WL 13238603, at *2 (Pa. C.P. Clarion Co. Nov. 3, 2015), aff’d, 163 A.3d 988 (Pa. Super. 2017) (OSHA)

Renninger v. A&R Machine Shop, 2015 WL 13238604, at *8-9 (Pa. C.P. Clarion Co. April 17, 2015)

Evidence of technological infeasibility under current state of the art is relevant/admissible

Igwe v. Skaggs, 258 F. Supp.3d 596, 611 (W.D. Pa. 2017) (on summary judgment)

And finally, to provide at least something that is specific to prescription medical products:

Existing exclusion of prescription medical products from strict liability applies after Tincher

Bell v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 928237, at *3 (W.D. Pa. Feb. 15, 2018)

Krammes v. Zimmer, Inc., 2015 WL 4509021, at *4-5 (M.D. Pa. July 24, 2015)

In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2015 WL 3669933, at *35 (N.D. Ill. June 12, 2015)

*          *          *          *

Is there any contrary Pennsylvania product liability precedent?  Well, we’re a defense-side blog and we don’t do the other side’s research for them.  That’s what plaintiffs’ side presumably paid for with the “research grant” that produced “Force Awakens” – and they didn’t get it.  PAJ should demand its money back.

Not so long ago the Philadelphia Court of Common Pleas emitted a malodorous opinion exercising personal jurisdiction over a foreign corporation because one of its materials suppliers was in Pennsylvania, even though the quality of that supplied material seemed to have nothing much to do with the injury, which occurred outside Pennsylvania.   That opinion seems to have mislearned the teaching of the SCOTUS BMS opinion.  Beyond that, the less said about it, the better.  But it was interesting to us how that rotten opinion did not address the plaintiff’s alternative argument that the corporate defendant’s registration to do business in Pennsylvania constituted consent to general personal jurisdiction.   Perhaps the court realized it had done enough damage by stretching specific personal jurisdiction beyond the bounds of reason.

Or perhaps the Philly court did not buy the consent argument.  And now we know that is the case because the same court and same judge issued an opinion rejecting the consent via corporate registration argument.  Mallory v. Norfolk So. Ry. Co., No. 1961 8-2 EDA, slip op. (Phila. C.C.P May 30, 2018), is actually a very good personal jurisdiction opinion.  Let’s pause, rub our eyes, take that in, and celebrate.

The plaintiff in Mallory was a railway carman in Virginia. He sued his railway employer, which was incorporated and had its principal place of business in Virginia, alleging that exposure to carcinogen caused him to suffer colon cancer.  The defendant was definitely not “at home” in Pennsylvania.  The exposure and injury did not occur in Pennsylvania.  So why was the case in Philadelphia?  Could it be the reputation Philadelphia juries enjoy for flipping million dollar verdicts around like nickels?  Yes, Virginia plaintiffs, there is a Santa Claus, and he sits on a jury in Philadelphia’s City Hall.  Virginia courts and juries, of course, have a very different reputation.

But even putting aside mere predilection, what could possibly be the basis for a Virginia plaintiff to sue a Virginia defendant in Philadelphia for injuries having nothing to do with Philadelphia?  The plaintiff hung jurisdiction on the defendant’s registration to do business in Pennsylvania.  The plaintiff was not merely engaged in wish fulfillment.  Section 5301 of the Pennsylvania Judiciary Act does, unfortunately, provide that qualification as a foreign corporation in Pennsylvania constitutes a sufficient basis for general personal jurisdiction.

The question, then, is whether exercising personal jurisdiction over a corporation that registered to do business in Pennsylvania, without more, comports with due process.  Put another way, whatever the statute says, does foreign corporate registration equal true consent – the kind of consent that can waive constitutional rights?

The Mallory court’s answer seems altogether obvious but, at the same time, remarkable given the court that is doing the answering.  It is actually a rather brave, as well as wise, decision.  The court reviews the Pennsylvania statutory scheme and concludes that the “Defendant’s consent to jurisdiction was not voluntary.”  If a foreign corporation does not register with the Commonwealth, it cannot do business in Pennsylvania.  Moreover, it would be prohibited from seeking any redress with the Commonwealth’s courts (you know – in cases where Pennsylvania jurisdiction actually made sense).  As the Mallory court reasons, “the Legislature imposed a punitive sanction upon those foreign corporations; it matters not if such a sanction is characterized as a carrot rather than a stick, the punitive result is the same.”  Put simply, foreign corporations have no choice but to register in Pennsylvania.  Having no choice is the antithesis of giving consent.  The Mallory court held that a state’s securing of general personal jurisdiction over a foreign corporation via what is essentially mandatory registration is an exercise of coercive power at odds with the SCOTUS BMS decision and due process.

To be sure, there are some old legal chestnuts out there that permitted “state courts to obtain personal jurisdiction over  foreign corporations via mandatory registration statutes” (e.g., Pennsylvania Fire Ins. Co. (1917)), but those cases “are relics of the Pennoyer era, in which a bright-line rule prohibited courts from exercising personal jurisdiction over persons or corporations outside the geographic boundary of the court.”  They have been effectively overruled.  And good thing, too.

By contrast to the Philadelphia court’s crabbed reading of the recent SCOTUS BMS case when it came to specific personal jurisdiction, the Mallory court’s reading of recent SCOTUS precedents on general jurisdiction is insightful and on the mark.  The Mallory court interprets recent SCOTUS cases as teaching that “federalism prevents this Court from exercising general jurisdiction over Defendant simply because Defendant does business in Pennsylvania.”  Thus, “[b]y requiring foreign corporations to submit to general jurisdiction as a condition of doing business here, Pennsylvania’s statutory scheme infringes upon our sister states’ ability to try cases against their corporate citizens.”  Yes, hurray for those sister states, with damages caps and parsimonious jurors.

The reasoning of Mallory in rejecting the consent argument is sound, it should apply to all Pennsylvania cases and, for that matter, cases anywhere.  Indeed, Mallory’s reasoning on the issue far exceeds that of several federal district courts in Pennsylvania, which have fallen for arguments that the Pennsylvania statute could somehow overcome constitutional restraints on general personal jurisdiction.

Now if only the courts here could screw their heads on right about specific jurisdiction.

This post is from the non-Reed Smith side of the blog.

Today is a follow-up post on Bell v. Boehringer Ingelheim Pharms, No. 17-1153, 2018 U.S. Dist. LEXIS 90337 (W.D. PA. May 31, 2018). When we last blogged about this case back in February, the court had tossed out everything except negligence and fraud/misrepresentation claims on well-settled Pennsylvania law that prescription drug cases sound only in negligence. The court then dismissed the remaining claims for failure to satisfy TwIqbal pleading standards. Plaintiffs were afforded an opportunity to amend and re-plead the claims recognized under state law. They did. And once again, they don’t get by TwIqbal.

So, what’s missing this time around? The court starts out by noting that despite being dismissed for factual insufficiency, plaintiff made few factual revisions in the amended complaint. Id. at *4. So few that the court was able to essentially adopt its factual recitation from the first decision. Id. That’s an underwhelming start and things don’t improve for the plaintiff as the court examines each claim in turn.

Starting with plaintiff’s catch-all negligence claim, the court found “[t]he amended complaint contains a boilerplate laundry-list of alleged negligence that is virtually identical to the negligence claim in the original complaint.” Id. at *12. Since plaintiff just re-packaged his conclusory allegations from the original complaint, the amended complaint once again fails to state “any facts about how defendants breached their duty or how defendants’ conduct caused [plaintiff’s] injury.” Id. at *13. At the heart of plaintiff’s negligence claim was his allegation that defendants should have changed their label to warn about the risk of kidney injury following FDA approval. But for that claim to survive, plaintiff would have had to have pleaded what new information became available to warrant a change, what the changed warning should have said, and how any alleged breach was the cause of plaintiff’s injury. Id. at *13-14. Absent all those pieces, plaintiff’s negligence claim was dismissed.

Negligent misrepresentation was even easier to dismiss because it was an exact duplicate of the original complaint. Id. at *14. We’ve all heard the expression that the definition of insanity is doing the same thing over and over and expecting a different result. Well, same allegations equal same result. Dismissal.

Next up was plaintiff’s negligent design claim. This claim was previously dismissed for failure to plead the availability of a safer, alternative design as required by Pennsylvania law. So, plaintiff argued he satisfied that requirement in the amended complaint by pointing to other available products. But different products are just that different products – not alternative ways to design the product at issue. Saying plaintiff could have taken a different product doesn’t do anything to establish how the design of defendant’s product was defective or how it could have been designed differently. Id. at *15. Another dismissal.

Last, plaintiff based his fraud claims on allegations that defendants concealed information about the risks of the drug from the FDA, the public, plaintiff, and plaintiff’s physicians. But fraud claims don’t just have to satisfy TwIqbal, they are held to the more rigorous Rule 9(b) standard. Generality won’t suffice. Id. at *16. And plaintiff’s claim was just that, too general. The amended complaint contained no allegations about what information was concealed. It was missing the “who, what, when, where and how” of defendants’ alleged fraud, i.e., the “first paragraph of any newspaper story.” Id. at *17. So, fraud was dismissed as well.

Despite the complete lack of factual support for any of plaintiff’s claims, he once again asked for a chance to re-plead. The court, somewhat reluctantly, granted the request but made it clear that any final attempt by plaintiff to fix these pleading deficiencies would have to be a significant improvement. Specifically, plaintiff has

to clearly articulate the legal theory he is pursuing and to allege sufficient facts to make each element of the claim plausible. He must also eliminate his overbroad, conclusory “shotgun” allegations so that defendants are given adequate notice of what [plaintiff] claims they did wrong.

Id. at *18-19. Given plaintiff’s track record, this seems like a fairly high hurdle to clear. Stay tuned to see if plaintiff tees it up for strike three.

 

Bexis decided to take a long Memorial Day weekend and to visit a part of the country he’d never seen before.  So adding a day to either side of the holiday, Bexis and his DDL wife took off for El Paso, and the twin national parks, Guadalupe Mountains and Carlsbad Caverns.  Memorial Day was an apt time of year, for another reason, because El Paso is one of the most militarily influenced places around.  “Old Ironsides” − the 1st Armored Division − is only one (the largest) of the units that keeps itself in readiness in the Fort Bliss desert vastness north of town.  We REALLY respect their service, especially after seeing an impressive array of equipment parked in one of the fort’s staging areas while flying out.

Just about all Bexis’ vacations involve hiking – and this was no exception. Guadalupe Peak is the highest point in Texas, and to get to the top requires a three-thousand foot climb, over the course of a little over four miles (each way), but neither altitude nor distance was the most serious issue.

No – heat was.

In these days of global warming, it just so happened that west Texas and southern New Mexico were in the midst of an epic heat wave. 101° was the lowest high temperature on any of the four days in the small (permanent 2010 population, 7) town of Whites City while Bexis was there.  The surrounding areas were just as hot.  So, precautions were necessary:  (1) extra water, 130 ounces per person (still not quite enough); (2) early starts (getting up early and hitting the trail at dawn); (3) freezing water bottles solid and packing the Camelbak with ice; and (4) taking a half-hour “reset” break about 2/3 of the way up to get body temperatures back to as normal as possible.

Guadalupe Peak was really hot – especially when the high clouds vanished on the descent (the immediate reason 130 ounces of liquid per person wasn’t enough).  The other outside trail Bexis hiked, called the Permian Reef, was not quite as bad, due to nearly constant strong winds.  The trails that weren’t hot were underground – Bexis spent six hours and hiked over four miles inside Carlsbad Caverns, including both entering and leaving via the natural entrance (where the bats come out at night).  The line for the elevator was over 1½ hour longs (or so they said), so Bexis hiked out in about half that time.  At a constant 56° temperature, the Caverns were a blessed fifty degrees cooler than the surface – not so hot.

Another recent thing Bexis encountered that wasn’t so hot was the long-awaited personal injury opinion out of the Philadelphia Court of Common Pleas in the Pennsylvania version of Pelvic Mesh Litigation.  See In re Pelvic Mesh Litigation, 021400829, slip op. (Pa. C.P. Phila. Co. May 18, 2018).  We knew the result would be adverse, as a one-page order to that effect (mentioned here) had issued back in December.  But the reasoning in the Pelvic Mesh opinion?

We grade it as poor – or maybe dreadful (on the Harry Potter grade scale).

This is Pennsylvania, after all – home of the bizarre corporate registration statute, 42 Pa. C.S.A. §5301, which uniquely imposes “general” jurisdiction on foreign corporations registering to do business in the Commonwealth.  That approach, jurisdiction by “consent,” is how pro-plaintiff federal courts have been allowing litigation tourism after Daimler AG v. Bauman, 571 U.S. 117 (2014).  See, for example, our post here about Bors v. Johnson & Johnson, 208 F. Supp.3d 648 (E.D. Pa. 2016), which permitted that unconstitutional ruse to succeed.

But, no, Pelvic Mesh doesn’t go the consent route.  See Pelvic Mesh, slip op. at 3 (“plaintiffs conceded that the court lacked general jurisdiction”).  Rather, the entire jurisdictional “hook” in Pelvic Mesh is that the target defendant contracted with other entities, and those other entities – not the target defendant – engaged in manufacturing operations in Pennsylvania.  Specifically, evidence was developed that:

[B]etween 2001 and 2015, [a Pennsylvania company] knitted the mesh used in all of the [eight types of mesh devices]. [The Pennsylvania company] was not involved in the manufacturing of [one other mesh device]. . . .  [T]his Court granted the Motion to Dismiss in part and denied the Motion to Dismiss in part.  This Court sustained personal injury over cases involving non-Pennsylvania plaintiffs implanted with the [eight types of] pelvic mesh devices, but found lack of personal jurisdiction over cases in which the non-Pennsylvania plaintiff was implanted with the [other] pelvic mesh device.

Pelvic Mesh, slip op. at 5 (record citations omitted).  The Pennsylvania entity knitted the “mesh according to specifications set forth by the Moving [that is to say, non-Pennsylvania] Defendants.  Id. at 4 (record citation omitted).

Under Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017) (“BMS”), case-linked personal jurisdiction must “arise out of or relate to the defendant’s contacts with the forum.”  Id. at 7 (quoting BMS). Pelvic Mesh held that sufficient contacts existed because:

Moving Defendants purposefully availed themselves of the privilege of doing business in Pennsylvania by reaching out to a Pennsylvania-based corporation . . . to fulfill its manufacturing needs. . . .   [A]n integral portion of the manufacturing process of the [eight types of] pelvic mesh devices occurs in Perkasie, Bucks County, Pennsylvania. . . .  Since a portion of the manufacturing process of the [eight types of] pelvic mesh devices occurs in Pennsylvania this Court’s exercise of specific personal jurisdiction comports with traditional notions of fair play and substantial justice.

Pelvic Mesh, slip op. at 9.  That’s essentially it.  The “relevant acts” of the non-Pennsylvania defendants consist entirely of “contracting with” a separate Pennsylvania company.  Id.  Conversely, the non-Pennsylvania plaintiffs “received a medical device that was manufactured, in part, in Bucks County Pennsylvania.”  Id. at 10.  Nothing more.

In particular, there is no causal link at all.  Nothing in the Pelvic Mesh opinion suggests that the Pennsylvania entity’s knitting process created any particular manufacturing defect, or that the non-Pennsylvania moving defendants knitting-related specifications created some sort of design defect.  Nor is there any indication that any plaintiff was actually injured as a result of any manufacturing process that took place in Pennsylvania – however the defect or duty might be described.

Since plaintiffs (the party with the burden of proof) adduced no causation-related evidence during jurisdictional discovery, Pelvic Mesh fell back on the vague manufacturing defect pleadings in the litigation’s master complaint:

A review of the Master . . . Complaint reveals that it contains a manufacturing defect claim. . . .  [T]he manufacturing defect claim alleges that the [Pennsylvania entity], along with the other named defendants, “deviated materially from their design and manufacturing specifications . . .”  The existence of this manufacturing defect claim grants this Court specific personal jurisdiction because, as detailed above, [the Pennsylvania entity] is involved in the manufacturing process.  The fact that other non-Pennsylvania plaintiffs have subsequently abandoned their manufacturing defect claim at the summary judgment state or at trial is irrelevant.

Pelvic Mesh, slip op. at 11-12 (record citations omitted).

Even by Philadelphia CCP standards, that’s pretty weak.  “‘[M]inimum contacts’ analysis looks to the defendant’s contacts with the forum State itself, not the defendant’s contacts with persons who reside there.”  Walden v. Fiore, 571 U.S. 277, 134 S. Ct. 1115, 1123 (2014) (emphasis added).  BMS specifically dealt with the “last ditch” argument that the defendant allegedly contracted with separate, in-state entity – and rejected it:

[A]s we have explained, the requirements of International Shoe must be met as to each defendant over whom a state court exercises jurisdiction.  In this case, it is not alleged that [defendant] engaged in relevant acts together with [an in-state entity] in California.  Nor is it alleged that [defendant] is derivatively liable for [the in-state entity’s] conduct in California.  And the nonresidents have adduced no evidence to show how or by whom the Plavix they took was distributed to the pharmacies that dispensed it to them.  The bare fact that BMS contracted with a California distributor is not enough to establish personal jurisdiction in the State.

BMS, 137 S. Ct. at 1783 (citations and quotation marks omitted).

Without any causation-related evidence, courts are simply looking at “contacts with persons who reside there.”  Walden, supra, see id. at 1122-23 (distinguishing prior decision on lack of causation evidence).  As the record stood in Pelvic Mesh, there’s no difference between that case and the last-ditch argument rejected in BMS about the defendant having contracted with an in-state third party.  No jointly engaged in “relevant act” exists in this record.  The “specifications” that the Pennsylvania entity followed remain unrelated to the plaintiffs’ injuries (which have to do with cutting the mesh, not knitting it, Pelvic Mesh, at 11).  No derivative liability is asserted – indeed, the Pennsylvania entity in Pelvic Mesh was statutorily immune from suit.  Id. at 10-11.  The “specifications” in Pelvic Mesh are thus no more relevant than it would have been in BMS to show that the distributor there (presumably) distributed products that carried the manufacturer’s purportedly defective labeling.

We have always thought that the “arise out of or relate to” language of the case-linked prong of personal jurisdiction contained enough “give” that in a proper manufacturing or design-related case, evidence of in-state manufacturing or design activities could support personal jurisdiction, where those contacts were relevant to the plaintiff’s injuries. Take a pacemaker, for example.  If the battery were defective, and the device failed, then manufacture of the battery in the forum state would be a sufficient jurisdictional contact – provided that’s why the device failed.  If the source of the device’s failure, however, was a defect in the pacemaker leads, then where a non-defective, non-causal battery was made becomes irrelevant to the jurisdictional analysis.

That’s the legal vice in Pelvic Mesh.  No evidence whatever ties the in-state manufacturing of a third party to any injury suffered by the litigation tourist plaintiff (who is not out of court, but can sue in her home state).  Parsing the manufacturing (or other process) without regard for causation, leads to the possibility of a defendant being sued just about anywhere, which is precisely what both Bauman and BMS hold is a constitutional no-no.  One sentence of conclusory boilerplate in a complaint can’t change the analysis, because jurisdictional motions are not limited to the pleadings (why the plaintiffs in Pelvic Mesh were allowed two rounds of jurisdictional discovery).

Nor should Pelvic Mesh’s concentration on a boilerplate manufacturing defect claim end the jurisdictional analysis, because – although not even mentioned in the opinion – jurisdiction over one claim does not necessarily confer jurisdiction over other, factually distinct claims.  As we discussed earlier this year:

Assuming there can be personal jurisdiction based on contractual relationships with third parties not named as defendants, there is a more basic flaw in these opinions. Just because there is specific jurisdiction over one claim (e.g., design defect), that is insufficient to find specific jurisdiction over all claims (e.g., warning claims, breach of warranty claims, and the laundry list of other claims that is usually appended to complaints against the pharmaceutical industry).

So it’s unlikely that a manufacturing defect claim – even if supported by the actual evidence – can supported design- or warning-based claims based on other facts unrelated to the moving defendants’ contract with a Pennsylvania third party.

But putting all the legalisms aside, there’s a larger practical vice to Pelvic Mesh’s grasping at any in-state jurisdictional straw it can find.  A third-party contractual relationship of the sort relied on by Pelvic Mesh to allow litigation tourists from all over the country to sue in Philadelphia is something that targeted defendants can, and will, change.  While decisions like Pelvic Mesh might mean lots of jobs for attorneys in Philadelphia (and lots of annoyance for Philadelphia citizens forced to serve on juries in such cases), in the future there won’t be much work for the folks who live in “Perkasie, Bucks County, Pennsylvania,” when defendants shift their manufacturing processes to places without Pennsylvania’s extreme pro-plaintiff tendencies.

In 1965, when Pennsylvania adopted strict liability, it had 29 electoral votes, to the combined 25 electoral votes of Virginia and North Carolina.  Now, the roles are reversed, with Pennsylvania having only 20 electoral votes to the combined 28 of Virginia and North Carolina – which have never adopted strict liability.  Over the years, Pennsylvania’s pro-plaintiff product liability law, in tandem with Philadelphia’s pro-plaintiff court system, have caused the Perkasies of the Commonwealth to lose a lot of manufacturing jobs to places like Virginia and North Carolina.  Fortunately for Perkasie, we think that Pelvic Mesh is so weakly reasoned that it should be reversed on appeal, even in Pennsylvania.

This post is from the non-Reed Smith side of the blog.

We’ve posted on two other occasions about the Shuker v. Smith & Nephew case as the Eastern District of Pennsylvania systematically dismantled the case on the grounds of preemption and pleading deficiencies. You can find those posts here and here. Unfortunately, the recent Third Circuit opinion deciding plaintiff’s appeal isn’t the full affirmance we had been hoping for. But before you get the wrong idea, the Third Circuit got the most important issue right – when you have a multi-component medical device, PMA preemption is to be addressed on a component-by-component basis. After that, however, the appellate decision does some unraveling of the district’s dismissal of the claims that survived preemption and so the case is going back to the Eastern District.

Briefly, the facts are that plaintiff underwent a hip replacement surgery in which his surgeon opted to use a Smith & Nephew device that consisted of several component parts, one of which was the R3 metal liner. Shuker v. Smith & Nephew, PLC, 2018 U.S. App. LEXIS 5160, *11 (3d Cir. Mar. 1, 2018). Unlike the other components of the device, the liner had undergone FDA Pre-Market approval. Id. And, the parties are in agreement that the surgeon’s decision to use the R3 metal liner with this particular device was an off-label use. Id. at *12. Plaintiff suffered complications that required additional revision surgeries.

In its first decision, the district court tossed out almost all claims as preempted and any non-preempted claims for being inadequately pleaded. When plaintiff filed an amended complaint attempting to correct the pleading deficiencies for the non-preempted claims, he again missed the mark and his remaining claims were dismissed with prejudice. The district court also entered a decision finding that it lacked personal jurisdiction over Smith & Nephew, PLC – a foreign parent company. Those three rulings are what the Third Circuit addressed in last week’s decision.

The question of how to apply PMA-preemption to a multi-component device was one of first impression in the Courts of Appeal. Id. at *2. And it is an important question because surgeons engaging in off-label use do mix and match parts with different regulatory backgrounds. The Third Circuit did a precise analysis that landed at the proper conclusion. However, the analysis does start up with a bit of a hiccup. Since we are talking about PMA-preemption, we are dealing with express preemption. Yet, in a footnote the court refused to follow the Supreme Court’s recent abolition of the presumption against preemption in the express preemption context set forth in Puerto Rico v. Franklin Cal. Tax-Free Tr., 136 S.Ct. 1938 (2016), because that decision wasn’t a products liability case and therefore did not directly concern the “historic police powers of the States.” Shuker, at *16n.9. We respectfully disagree with this conclusion for all the reasons we mention in our post discussing Franklin and simply point out that other courts have reached the opposite conclusion. Accord Watson v. Air Methods Corp., 870 F.3d 812, 817 (8th Cir. 2017) (following Franklin and rejecting presumption against preemption in express preemption case); EagleMed LLC v. Cox, 868 F.3d 893, 903, (10th Cir. 2017) (same); Atay v. Cty. of Maui, 842 F.3d 688, 699 (9th Cir. 2016) (same); Conklin v. Medtronic, Inc., ___ P.3d ___, 2017 WL 4682107, at *2 (Ariz. App. Oct. 19, 2017) (under Franklin courts may not invoke a presumption against preemption in PMA preemption cases); Olmstead v. Bayer Corp., 2017 WL 3498696, at *3 n.2 (N.D.N.Y. Aug. 15, 2017) (plaintiff’s assertion of presumption against preemption in PMA preemption case held “frivolous” after Franklin).

Fortunately, that did not derail the Third Circuit from ultimately concluding that plaintiff’s negligence, strict liability, and breach of implied warranty claims were all preempted under Riegel. To do that, the court had to determine to what device it was applying the preemption analysis. Plaintiff argued that you have to look at the device that was implanted as a whole. Whereas defendant, bolstered by an amicus brief filed by the FDA at the court’s request, maintained that the proper focus is on the component of the device with which plaintiff takes issue. Shuker, at *18. Agreeing with the defense position, the court anchored its decision on three findings. First, the FDCA defines “device” to include “components, parts, and accessories.” Id. at *19. Second, the FDCA’s off-label provisions specifically acknowledge that a physician can and will use components separately from the system for which the FDA approved use. Id. at *20. And despite the use to which the component is put, the FDA’s PMA-regulations for the component follow with it. In other words, “premarket approval requirements apply equally to the components, as manufacturers generally may not deviate from the requirements imposed through premarket approval regardless of how [a component] is used.” Id. (citation and quotation marks omitted). Third, the FDA’s position is that the device is not limited to the device as a whole but includes components. Further, the FDA is charged with assuring the safety and effectiveness of components as well as finished devices. Id. at *21-22.

Therefore,

[t]aken together, the statutory definition of “device,” the treatment of off-label uses, and the guidance of the FDA all counsel in favor of scrutinizing hybrid systems at the component-level. . . .. And the Riegel test is properly framed at Step One as “whether the Federal Government has established requirements applicable” to a component of the hybrid system.

Id. at *22-23. Because the part of the device plaintiff attacked was the R3 metal liner which was premarket-approved, any state tort claim that seeks to impose requirements that are different from or in addition to the FDA’s requirements for that component are preempted. That includes plaintiff’s negligence, strict liability, and implied warranty claims.

The appellate court next reviewed the dismissal of plaintiff’s claims that survived preemption – negligence and fraud claims based on alleged off-label promotion in violation of federal law – and found the negligence claim was adequately pleaded but that plaintiff failed again to satisfy Rule 9’s heightened standard for pleading fraud. As to negligence, the court found TwIqbal satisfied as to duty, breach, causation where plaintiff alleged:

  • the R3 metal liner was approved only for use with a different system and therefore under federal law defendant had a duty to refrain from false or misleading advertising;
  • in a press release, defendant misleadingly marketed the R3 metal liner as an option for the system used by plaintiff’s surgeon (one other than the one it was approved for); and
  • plaintiff’s surgeon “either read” or “was aware” of the press release.

Id. at *28-29. Like the district court, the Third Circuit considered and relied upon the press release cited in plaintiff’s complaint. Unlike the district court, the Third Circuit appears to only focus on the portions of the press release upon which plaintiff relied (see prior post for more details) and concludes that’s enough to get plaintiff to the discovery stage. Id. at *29n.18. Although we wonder if the court’s calling plaintiff’s allegations enough to “nudge” the claim over the threshold is a veiled acknowledgement of just how narrowly the complaint squeaked by. See id. at *30.

Meanwhile, plaintiff’s fraud claim needed more than a nudge and it didn’t get even that. The court focused on plaintiff’s failure to plead justifiable reliance on the alleged misrepresentation. The “read” or “was aware” of allegation that sufficed for negligence lacked the requisite details regarding how the press release “induced or influenced” plaintiff’s surgeon for a fraud claim. Id. at *33-34. Plaintiff has to allege the “circumstances of the alleged [influence on Mr. Shuker’s surgeon] with sufficient particularity to place [defendant] on notice of the precise misconduct with which it is charged.” Id. at *34. Despite this having been plaintiff’s second failed attempt at meeting the pleading standard on fraud, the Third Circuit decided to give plaintiff another chance and found the claim should only be dismissed without prejudice.

Finally, there was a separate finding by the district court that it did not have personal jurisdiction over Smith & Nephew, PLC, a foreign parent company. The Third Circuit agreed with the district court that specific personal jurisdiction was not conferred on a stream-of-commerce theory. Id. at *36-37. We’ve talked about this before and more recently in light of BMS v. Superior Court, and like the Third Circuit “we have no cause to revisit” the precedent on the issue (but you should feel free to). But the court did think plaintiff alleged enough in his complaint to allow some limited jurisdictional discovery on possible alter ego based personal jurisdiction. Id. at *38-40. Emphasis on the limited part. See id. at *40n.20 (“District Court should take care to circumscribe the scope of discovery . . . to only the factual questions necessary to determine its jurisdiction;” further referencing proportionality amendment to Rule 26(b)(1)).

So, on the third pass plaintiff got a little life breathed back into this case which is unfortunate, but as the first appellate decision on component preemption – we’ll put it in the win column.

This should not be controversial. It has been settled since Hahn v. Richter, 673 A.2d 888 (Pa. 1996) that in Pennsylvania prescription drugs are exempt from strict liability. And since Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014) re-worked Pennsylvania’s strict liability law, we’ve only reported one federal court decision that erroneously, in our opinion, concluded that Tincher allowed a strict liability manufacturing defect claim in a prescription medical device case. But that hasn’t stopped plaintiffs from continuing to try to pursue strict liability under Pennsylvania law. The most recent federal court to be confronted with the argument rejected it outright. Some TwIqbal and preemption are in the mix too so this one really hits on some of our favorites.

Plaintiff alleged he developed an acute kidney injury as a result of taking the prescription drug Jardiance. Bell v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 U.S. Dist. LEXIS 24802, *1 (W.D. Pa. Feb. 15, 2018). Defendants moved to dismiss the complaint on three grounds: 1) Pennsylvania law bars all non-negligence based claims; 2) the complaint fails to satisfy TwIqbal across the board; and 3) the claims against the non-NDA holding entity are preempted. Id. at *2-3.

Defendants’ first argument sought to dismiss not only strict liability design defect and failure to warn, but also gross negligence, breach of express and implied warranty, and all fraud and misrepresentation claims. Plaintiff’s response on strict liability was that Hahn is “antiquated.” Id. at *7. Hahn may be about to turn 22, but that means it’s only been legally drinking in bars for a year. Hardly over the hill. Not to mention, antiquated isn’t a legal standard that would allow a federal court to simply ignore the controlling law as announced by a state Supreme Court. Further, the court points out that Tincher expressly recognized the Hahn prescription drug exception (as did Lance v Wyeth, 85 A.3d 434 (Pa. 2014) which demonstrates that the Pennsylvania Supreme Court has not changed its position – Hahn is still good law. See Bell at *7-8.

But Hahn doesn’t just say no strict liability, it says “that negligence is the ‘only’ recognized basis of liability” in prescription drug cases. Id. at *8. So, on that basis, and ample federal precedent, the court dismissed plaintiff’s breach of warranty claims. Id. at *8-9. The case law applying Hahn to fraud and misrepresentation claims appears to be more divided and on this one the court opted to follow the cases that adopted a more narrow interpretation. Id. at *9-10. We think Hahn’s negligence only holding could easily be read as a bar to intentional misrepresentation and fraud which do not sound in negligence. The Bell court, however, concluded that because Hahn requires manufacturers to warn of both risks that should have been known as well as risks that were known, the latter is akin to a claim of intentional concealment of a known risk which would support a fraud or misrepresentation claim. So, those claims were not barred by Hahn.

The last challenge was to plaintiff’s gross negligence claim which the court dismissed as not recognized as an independent cause of action in Pennsylvania. Id. at *11.

But we need to quickly return to plaintiff’s surviving negligence and fraud/misrepresentation claims. They aren’t barred, but neither were they adequately pleaded. Apparently plaintiff’s counsel did not do a good job proofing the complaint because the court pointed out it appeared to be cut and paste from another complaint filed by a woman. Id. at *13 (complaint uses “her” and “she” pronouns). Cookie cutter complaints don’t survive under TwIqbal because they lack any of the necessary factual detail to support plaintiff’s claims. This complaint contained

no factual details about when Bell contracted diabetes, whether he has type I or type II diabetes, whether he has other medical conditions, who his treating physicians were, why he decided to take Jardiance, what alternatives to Jardiance were discussed, whether he read the warnings, how long he took Jardiance or at what dose or why he believes his acute renal failure was caused by Jardiance.

Id. The complaint was equally lacking regarding defendants. There were no specific allegations concerning how the warnings “fell below the standard of care,” how any defendant’s alleged breach of duty caused plaintiff’s injury, how the design was defective, or what safer alternatives existed. Id. at *13-14. The court was unwilling to “infer defectiveness” based only on “a generic description of how [the class of drugs] work[s]” and “formulaic legal conclusions.” Id. at *15.

All claims were dismissed under TwIqbal, but plaintiff only gets to amend his complaint to try to state a claim for those that survived the first part of the court’s analysis as recognized under state law.

So, that brings us to the final question – are the claims against the non-NDA holder preempted on the grounds that it had no ability to change the drug’s label or design. The plaintiff seemingly concedes that post-approval design defect claims would be preempted, but that he is making a claim that the defendant should have designed a safer product before approval. Id. at *17-18. The court briefly discussed some cases that have dealt with the issue of pre-approval design defect claims. We cover it here, along with our analysis that there is no such valid claim. But, because none of plaintiff’s claims survived TwIqbal, the court didn’t have to decide the preemption issue. Defendant can re-raise it after plaintiff files his amended complaint.

 

If you’re not interested in Pennsylvania product liability law at the moment, come back tomorrow. This particular post is not limited to (or even primarily about) prescription medical products.

Back in 2014 the Pennsylvania Supreme Court worked a revolution in product liability when it decided Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014) (“Tincher I”).  We blogged about Tincher I here and here, and discussed its prescription medical product implications (or lack of same) here and here.

We detailed in our first post the harsh criticism that Tincher I directed against the strict liability jury instruction (from a case called Azzarello) that had previously been the law.  Here is some flavor from that post – there’s lots more where that came from.

After all that preface, Tincher overruled Azzarello.  “Azzarello articulates governing legal concepts which fail to reflect the realities of strict liability practice and to serve the interests of justice.”  Slip op. at 74.  It got rid of Azzarello’s relegation of the “unreasonably dangerous” prong of §402A to a preliminary question of law to be decided courts rather than juries.  It criticized Azzarello for “approv[ing], and thereby essentially requir[ing], instructions which informed the jury that, for the purposes of a supplier’s strict liability in tort, ‘the product must, therefore, be provided with every element necessary to make it safe for its intended use’.”  Id. at 75.  “Subsequent decisional law has applied Azzarello broadly, to the point of directing that negligence concepts have no place in Pennsylvania strict liability doctrine.” Id.     These errors, Tincher went on to explain, “led to puzzling trial directives that the bench and bar understandably have had difficulty following in practice, including in the present matter.” Id.

Thus, Tincher disapproves of three key aspects of prior Pennsylvania strict liability law:     (1) the “each and every element”/”guarantor” jury instruction; (2) taking “unreasonably dangerous” issues away from the jury and giving them to courts; and (3) the strict separation of negligence and strict liability concepts.

Thus, one thing that we always considered self-evident is that, after Tincher I, the Azzarello jury instruction – the one with the “any element” defect test and the “defendant as guarantor” of product safety language – was reversible error.

However, others seemed to have much more trouble with this self-evident proposition than we did. Because Tincher I did not reverse outright, but simply remanded for further proceedings, the plaintiffs’ side tried to throw smoke that maybe the Azzarello instruction was still OK (or at least not reversible error).  A couple of foolish, but fortunately uncitable, Superior Court memorandum decisions seemed to agree, at least in crashworthiness cases. See American Honda Motor Co. v. Martinez, 2017 WL 1400968, at *4 (Pa. Super. April 19, 2017); Cancelleri v. Ford Motor Co., 2016 WL 82449, at *2 (Pa. Super. Jan. 7, 2016).  Even more foolishly, a post-Tincher I update to the Pennsylvania Suggested Standard Jury Instructions, retained the Azzarello “any element” defect test, while omitting the “unreasonably dangerous” element of strict liability that Tincher I reaffirmed as part of Pennsylvania law. See Pa. SSJI (Civ.) §16.20(1).  At that point, this continuing denial of the obvious became too much for Pennsylvania defense practitioners to suffer in silence any longer.  Thus, last year the Pennsylvania Defense Institute, later joined by the Philadelphia Association of Defense Counsel, issued their own competing product liability suggested jury instructions.  Anyway, these plaintiff-side attempts to deny the obvious are now at an end.

As we mentioned, Tincher I remanded for further proceedings concerning the relief to which the defendant was entitled.  On remand, the trial judge also tried to deny the obvious, and denied any relief at all, finding the Azzarello instruction to be, at most, harmless error even after Tincher I.  But yesterday the Superior Court unanimously reversed that holding in a published opinion. See Tincher v. Omega Flex, Inc., ___ A.3d ___, No. 1285 EDA 2016 (Pa. Super. Feb. 16, 2018) (per Lazarus, J., with Platt, and Strassburger, JJ., joining) (“Tincher II”).

Here are the highlights. Tincher II held that the Pennsylvania Supreme Court meant what it said in Tincher I, so that a court commits “fundamental error” if it uses an Azzarello jury charge in a strict case. Tincher II, slip op. at 23.  What language was fundamental error?  This language:

The charge [that was given] contained all of the product liability law under Azzarello that the Supreme Court has now disapproved, including a definition equating a defective product with one that “leaves the suppliers’ control lacking any element necessary to make it safe for its intended use,” and a declaration that a manufacturer “is really a guarantor of [a product’s] safety” but not “an insurer of [that] safety.”

Id. at 18.  Tincher II did not consider this to be a difficult ruling.  “There is no question” that the Azzarello charge given during the trial was “incorrect.”  Id.  Indeed, as “the trial court gave a charge under law that the Supreme Court has explicitly overruled in this very case.  Such a charge would appear to be a paradigm example of fundamental error.”  Id. at 23 (emphasis added).  Likewise, on page 20 of the Tincher II slip opinion:  an Azzarello charge “fail[s] to conform to the applicable law, as stated in Tincher” and thus is “fundamental error.”

There’s lots more where that came from:

  •  “If an incorrect definition of ‘defect’ under Azzarello calls for a new trial, an incorrect definition of ‘defect’ under Tincher should call for the same result.”  Tincher II, slip op. at 22-23.
  •  “There is no question that the error was fundamental to the case. It dealt with the principal issue disputed by the parties − whether there was a defect.”  Id. at 25.
  • “[T]hat the jury may have heard evidence about risk and utility during the trial does not mean that it rendered a verdict based on the risk/utility standard adopted by the Supreme Court as one way to find a product defective.  In fact, the verdict could not mean that, because the jury was never instructed to make findings under such a standard.  Rather than being asked to balance risks and utilities, the jury was told only to find whether [product] “lacked any element necessary to make it safe” − regardless of whatever reasonable risk/utility considerations might have gone into the decision to market [product] without such an element.”  Id. at.26.
  • “[T]he trial court had no authority to deny a new trial on the basis of its own speculation about what the jury would do under the Supreme Court’s new formulation of the law.”  Id. at.27.
  •  “The trial court’s declaration that the new legal reformulation resulting from the Supreme Court’s thorough and extensive decision . . . can cause no change to the verdict undervalues the importance of the Supreme Court’s decision.” Id. at 27 (emphasis added).
  •  “The Supreme Court said nothing in Tincher[I] to suggest that mere proof of a ‘defect’ under post-Azzarello strict liability law would be sufficient to prove an “unreasonably dangerous defective condition” under Tincher[I]’s new formulation.”  Id. at 28.
  •  “[T]he Supreme Court’s statement that the ‘question of whether a party has met its burden of proof’ may properly be removed from a jury’s consideration” . . . was referring only to a trial court’s ability to decide ‘a dispositive motion.’” Id. at 29.

Thus, in a precedential opinion, Tincher II has at last answered the obvious question.  Yes, after Tincher I, charging a §402A strict liability jury in Pennsylvania with the old Azzarello “any element”/”guarantor” language is “disapproved,” “incorrect,” “fundamental error,” and in and of itself requires a new trial.  Go forth and sin no more.

 

This post is from the non-Dechert side of the blog.

While the recent Pennsylvania Superior Court Risperdal decision is not a defense victory, it is certainly not as favorable for plaintiffs as they are making it out to be. While several issues were presented for appeal in Stange v. Janssen Pharms., Inc., 2018 Pa. Super. LEXIS 11 (Pa. Super. Jan. 8, 2018), the most important one was whether the trial court was incorrect in applying New Jersey law to plaintiff’s punitive damages claim. While plaintiffs are characterizing the decision as answering that question in the affirmative, what the court really said was maybe.

In the consolidated In re Risperdal litigation pending in the Philadelphia Court of Common Pleas, the coordinating judge granted defendants’ motion for summary judgment on punitive damages finding that the law of New Jersey, defendant’s principal place of business, applied and that under the New Jersey Product Liability Act, punitive damages are precluded in cases involving FDA approved products. Id. at *32-33. In opposition to defendants’ motion, plaintiffs argued the law of the case doctrine or in the alternative that the court should apply Pennsylvania law instead. Id. Their law of the case argument was based on the judge’s decision in three prior Risperdal cases to apply the punitive damages law of plaintiff’s home state. Id. at *35n.6. The trial court ruled that those cases were separate cases and therefore law of the case did not apply or if they were considered the same case as In re Risperdal, the same judge made all four rulings and a judge is entitled to revisit his earlier rulings “without running afoul of the law of the case doctrine.” Id. (citation omitted).

With that ruling in place, the Stange case went to trial with no punitive damage claim. Stange is a resident of Wisconsin which is where he was prescribed Risperdal and treated for his alleged injury, gynecomastia. Unlike New Jersey, Wisconsin does not have a bar on punitive damages for FDA approved products. Under Wisconsin law, however, punitives would be capped at twice the amount of any compensatory damages or $200,000, whichever is greater. Id. at *42. So, there is a clear conflict of law.

On appeal, plaintiffs argued that the trial court’s global ruling on punitive damages was improper because Pennsylvania law on choice of law requires an analysis of which state has the greatest relationship and interests in each individual plaintiff’s case and that that analysis supports applying plaintiff’s home state’s punitive damages law. Id. at *33. Plaintiffs did not argue for application of Pennsylvania punitive damages law on appeal. Id. at *43n.8. Defendants argued that plaintiffs’ choice of law argument had been waived because it was first raised in plaintiffs’ motion for reconsideration of the global punitive damages ruling. Id. at *37. The Superior Court, however, found plaintiffs’ arguments preserved. In the context of their law of the case doctrine argument which urged the court to follow its earlier decision to apply plaintiff’s home state law, plaintiffs “argued more generally that the law of the plaintiffs’ various home states should apply to punitive damages.” Id. at *39.

So, what the Superior Court concluded was that the choice of law analysis was not waived and that a choice of law analysis as between New Jersey and Wisconsin needed to be undertaken:

the trial court only considered whether New Jersey or Pennsylvania law should apply, not the law of the individual plaintiff’s home state. We agree with Stange that it is necessary to remand for the trial court to allow Stange to develop an individual record on choice-of-law as it relates to his unique circumstances and to set out the facts and state interests important to his particular case.

Id. at *45. Nowhere in the decision does the court make any finding with regard to what the outcome of the choice of law analysis should be on remand, only that the analysis needs to be done. There is nothing prohibiting the trial court from reaching the conclusion in Stange that it did in In re Risperdal globally – that New Jersey has the more significant relationship and interests on the punitive damages claim. Indeed, having reached that decision once already we struggle to understand how the facts of any particular case will impact the court’s analysis. For the underlying substantive claims, most choice of law analyses will favor plaintiff’s home state – where he was prescribed, where he suffered his injury, where he was treated. But the alleged corporate misconduct giving rise to the claims for punitive damages occurred in New Jersey. It is there that the company developed the Risperdal labeling and its marketing and sales strategy and from there that it had communications with the FDA. Id. at *44.  So, even on a case-by-case basis, there is ample support for a finding that in a failure to warn case, the proper focus for purposes of a choice of law analysis on punitive damages is the place where the alleged corporate misconduct occurred.

So we think plaintiffs are celebrating a bit prematurely. The Stange decision may have removed the foil and even loosened the wire cage, but the cork remains in place.

As we noted at the outset, punitive damages choice of law was not the only issue on appeal and so we make passing mention of two other noteworthy aspects of the case. First, defendants challenged the trial court’s admission of certain expert testimony on the grounds it did not meet Frye standards. Id. at *8-9.  The Stange, court however erroneously applied the novelty limitation from Trach v. Fellin, 817 A.2d 1102 (Pa. Super. 2003) – that Frye only applies to the most “novel” of scientific testimony. That narrow interpretation was rejected by the Pennsylvania Supreme Court in Betz v. Pneumo Abex LLC, 44 A.3d 27 (Pa. 2012), a case not cited in Stange.

Second, it was agreed that Wisconsin law governed the substantive claims in the case. While examining the issue of proximate cause on failure to warn, specifically whether plaintiff had carried his burden of proving a different warning would have changed plaintiff’s prescribing physician’s decision to prescribe, the court applied the learned intermediary rule which has never been adopted by any appellate court (only trial courts, which have split) under Wisconsin law. Id. at *22n.4 (no conflict between Pennsylvania and Wisconsin law on the scope of learned intermediary doctrine). We’ll add it to our learned intermediary “head count.”

Happy birthday, Christopher Plummer.   The great Canadian actor turns 88 today, and seems as vibrant as ever.  What a marvelous career Plummer has had.  He is a preeminent Shakespearean actor.  We saw him play Iago to James Earl Jones’s Othello on Broadway 35 years ago.  Of course, most people remember Plummer as Captain Von Trapp in The Sound of Music (1965), a film for which Plummer reserves enormous contempt, referring to it (if at all) as “The Sound of Mucus.” Much more recently, we enjoyed Plummer’s flinty interpretation of Ebenezer Scrooge in The Man Who Invented Christmas.  And there has been abundant publicity over Plummer’s replacement of Kevin Spacey in House of Cards.  It seems a thankless task to succeed someone in such scandalous circumstances.  But we’ll thank Plummer, if only because he supplied a (strained) segue into today’s post, which is about successor liability.

 

More specifically, we have a pro-defense decision on successor liability with respect to a bankrupt medical device manufacturer. The court holds that there is no liability for design and manufacturing claims under either NY or PA law – including PA’s peculiar product line liability theory. The court concludes as a matter of law that product line liability applies only to manufacturers, not to distributors. But there is a fly in the ointment: the court’s conclusion on the failure to warn claim is rather muddled – to the point where that cause of action is not concluded at all.

 

In Deluca v. Portland Orthopaedics Ltd., et al., 2017 U.S. Dist. LEXIS 198962 (E.D.N.Y. Dec. 2, 2017), a husband and wife sued for injuries relating to a failed hip implant. The husband and wife lived in New York. That is where the 2009 implant operation took place. That is also where the injury – the 2012 failure of the implant – took place. The implant was manufactured by Portland, an Australian company that had entered into receivership shortly before the plaintiff’s implant operation and that had sold off its assets before the implant failed three years later. The plaintiffs sued Portland, as well as the Singapore successor company and its manufacturing and distributing affiliates, which were incorporated in Pennsylvania (not something we’d ever recommend doing). The complaint included claims for strict liability (failure to warn, manufacturing defect, and design defect), negligence, and breach of warranty – the usual. Portland never appeared on the case and was dismissed. One presumes it would be judgment-proof. The remaining defendants moved for summary judgment, and their arguments centered around successor liability – or, to be precise, absence of successor liability. The court sensibly held that New York law governs because that is where the injury occurred, but the court also treats us to an analysis under Pennsylvania law, where it arrives at the same destination, albeit via a slightly more complicated route.

 

The successor corporation purchased certain assets of Portland. There was no purchase of stock or any formal merger. Under those circumstances, the successor typically does not acquire prior tort liabilities. That is the law in both New York and Pennsylvania. There are some exceptions to this general rule, but none applies here.

 

New York recognizes four possible exceptions, none of which saved the plaintiffs’ design or manufacturing defect claims:

 

First, the successor did not expressly or impliedly assume prior liabilities. In fact, those liabilities were expressly excluded.

Second, the de facto merger exception does not apply. There was no continuity of ownership, management, or physical locations. In addition, the seller continued to exist, even if only in gossamer form.

Third, the “mere continuation” exception does not apply. Again, the seller lingered, and there was no hint of overlapping owners or managers.

Fourth, there is no evidence that the asset sale was a fraudulent effort to evade liability.

 

Pennsylvania adds another factor – whether the transfer was made without adequate consideration and without provisions for creditors of the selling corporation. That factor also does not apply here. More significantly, or problematically, some Pennsylvania courts have announced a “product line” exception, an extreme pro-plaintiff doctrine left over from the 1980s. The Deluca court is not persuaded that this exception has been endorsed by the Pennsylvania Supreme Court. And remember that the Deluca court has chosen New York law to govern this case. Nevertheless, just in case some appellate court might get dodgy, the Deluca court goes through the motions of measuring the evidence in the case against the product line exception and concludes that it does not help the plaintiffs here. The factors animating the product line exception are pretty fuzzy: (1) whether the purchase of the product line caused the “virtual destruction of the plaintiff’s remedies against the original manufacturer,” (2) does the successor have the ability to assume the original manufacturer’s “risk-spreading role,” and (3) the fairness of requiring the successor to assume responsibility insofar as the successor was enjoying the original manufacturer’s good will.

 

The Deluca court easily dispensed with these factors by pointing to some important facts:

 

  1. Portland’s insolvency preceded the asset sale, and was certainly not caused by it.
  2. The asset sale was not prompted by any scheme to evade product liability claims. At the time of the sale, the problem of implant failures was not on the radar screen.
  3. The purchase agreement explicitly excluded goodwill as well as related liabilities.

 

Further, the Deluca court held that the product line exception could not be used against the defendants who were never involved in manufacturing. Thus, even if someone wanted to shape the gooey product line factors so as to preserve claims against a successor, the distributor defendants would still be off the hook.

 

The plaintiffs requested additional discovery on the successor liability question. The Deluca court refused that request on both procedural and substantive grounds. The procedural problem for the plaintiffs was that they failed to submit a Rule 56(d) affidavit documenting what discovery would be sought and why it wasn’t obtained earlier. The substantive ground was futility. Even from the face of the plaintiff’s’ arguments, it was clear to the court that the request was a mere fishing expedition, with no justification for the delay and no expectation that anything reeled in would make a difference.

 

So far so good for the defense. But the court also kept the failure to warn claim alive, at least for now. New York law recognizes that successor corporations sometimes have an independent duty to warn. That duty arises not from succession of the prior manufacturer’s duties, but from the successors’ relationship with customers. Here, the plaintiffs alleged that a sales representative working for one of the defendants was in a position to provide additional warnings to the treating doctor. We do not know what those warnings would be, and are not sure how they would fit into the chronology of the case. The defendants pointed to the Instructions for Use as containing ample warnings. The Deluca court responded that it is unclear whether the physician received the IFU or whether the warnings were in fact adequate.

 

To our eyes, those questions should not be enough to stave off summary judgment. How could the doctor not have access to the IFU? Is there any suggestion that the defendants did something to make the IFU unavailable? Seems unlikely. How is the adequacy of the warning not an issue of law? And is there any open issue of warning causation? That is, did the plaintiffs proffer any evidence that a different warning – whatever that might be – would have changed the doctor’s mind in such a way as to avoid the alleged injury? On these points, the court’s reasoning is full of holes.  We suspect that the plaintiffs will ultimately be unable to fill those holes with evidence.  Then the defendants will be in a position to borrow a title from the Bard: all’s well that ends well.

 

We thought we were on a winning streak on medical monitoring.   In August, we blogged about plaintiff lawyers stumbling in their efforts to walk the not-quite-yet-injury line.  https://www.druganddevicelawblog.com/2017/08/monitoring-the-death-of-medical-monitoring.html   In September, we blogged about a denial of a medical monitoring class action because the issues were more specific than common. https://www.druganddevicelawblog.com/2017/09/medical-monitoring-class-certification-fails.html.  But with the falling leaves come falling defense fortunes in the area of medical monitoring, as Judge Jones (a smart and careful judge, which does not mean we always have to agree with him) in the Middle District of Pennsylvania refused to dismiss a rather frail medical monitoring case.  The case is Baker v. Deutschland GMBH et al., 2016 U.S. Dist. LEXIS 189429 (M.D. Pa. Oct. 11, 2016).  The court denied a motion to dismiss a medical monitoring/declaratory judgment case involving allegations that a medical device, a heater-cooler system used to regulate blood temperature during open heart surgeries, exposed surgical patients to potentially fatal bacterial infections.  The plaintiffs styled the case as a putative class action for medical monitoring that also sought a declaratory judgment of defect (which, to our jaundiced, baggy defense-hack eyes looks to be both an effort to create settlement leverage and a dodge around the issue of class certification) despite the fact that medical monitoring claims in Pennsylvania sound in negligence.

 

The hospitals involved in the surgeries had announced to the public that over 3500 patients had potentially been exposed to the bacteria during their heart surgeries.  The bacteria in question occur naturally in the environment and rarely cause illness, but they pose “a unique health risk to those with compromised immune systems, and in particular those who have undergone invasive surgical procedures.”  It can take anywhere between two weeks and four years for an infection to manifest itself in an exposed patient.  Even when manifested, the symptoms are non-specific and may present in the form of “fever, pain, redness, heat or pus around a surgical incision, night sweats, joint pain, muscle pain and fatigue.”  If diagnosed early, an infection from these bacteria may be successfully treated with antibiotics.  But late “diagnoses pose a significant risk of death for those with weakened immune systems.”  The recommended monitoring period after exposure to the bacteria is at least four years. The plaintiffs sought class certification for those who underwent open heart surgeries at certain hospitals during the respective time periods and who are currently asymptomatic for the bacterial infection.  In response to the risk of exposure, the hospitals created on-site, free clinics for patients to “obtain screening for and medical treatment associated with diagnosed infections.”  Later, the FDA issued a Class 2 recall of the blood heater-cooler system, citing to the potential for colonization of organisms when “proper disinfection and maintenance is not performed per instructions for use.”

 

The defendants moved to dismiss the medical monitoring claim.  Just to review, here are Pennsylvania’s elements of a medical monitoring claim:   (1) exposure greater than normal background levels; (2) to a proven hazardous substance; (3) caused by defendants’ negligence; (4) as a proximate result of the exposure, plaintiffs have a significantly increased risk of contracting a serous latent disease; (5) a monitoring program procedure exists that makes the early detection of the disease possible; (6) the prescribed monitoring regime is different from that normally recommended in the absence of exposure; (7) the prescribed monitoring regime is reasonably necessary according to contemporary scientific principles.  The defendant argued that (1) the plaintiffs could not allege a plausible claim that they were exposed to “more than the ‘mere possibility’ of exposure beyond what they would normally encounter,” (2) failed to allege a “significantly increased risk of contracting serious latent disease,” and (3) failed to allege that a “monitoring program will make early detection of disease possible.”

 

The Baker court rejected these arguments, pointing to allegations in the complaint that the hospitals had announced the exposures during surgery, that the heater-cooler system had aerosolized the bacteria and thereby exposed the plaintiffs to a greater amount of the bacteria than would normally be the case, that prompt detection of the bacterial infection could lead to successful treatment, and that the hospitals seemed to think that monitoring was beneficial inasmuch as they offered free clinics. Maybe some or all of these allegations would turn out to be bunk, but the court held that a motion to dismiss was not the vehicle for resolving that.  Further, the court held it significant that the plaintiffs had established plausibility by alleging that other patients similarly situated had contracted infections and suffered injuries – five of whom passed away. The court reasoned that requiring more from the plaintiffs at the pleading stage made little sense since “by its nature, a medical monitoring claim attracts Plaintiffs who have not yet shown symptoms of exposure.”

 

The defendants also moved to dismiss the declaratory judgment action on the defect issue.  The defense theory was that, because strict liability does not apply to medical devices in Pennsylvania, declaration of a defect is inappropriate.  We might even call it gratuitous. The defendants also argued that a declaration of defect is inconsistent with the plaintiffs’ lack of injuries, and that, in any event, such a declaratory judgment would be ill-suited for a case about negligence – i.e., a finding of defect would not conclude the entire controversy. Again, the court rejected these arguments, holding that product defect is legally relevant to product liability claims outside the realms of strict liability, including negligence based charges. The court said that a declaration of defect would “finally resolve an issue between the parties that will undoubtedly be part of this litigation and potentially future claims as well.”  Sorry, but that seems like a stretch to us.  (We looked for a discussion of the SCOPA Tincher case, but did not find it.)  It also seems like a waste of time.  Perhaps the court was on slightly less shaky ground when it ruled that absence of physical injury was not a necessary element to the plaintiffs’ claims. It all comes down to the court’s discretion whether to hear a declaratory judgment action.  The court exercised its discretion to hear the claim, or at least hear more of it, while some other courts (certainly a court helmed by an author of this blog) could and would go the other way.

 

This litigation appears very muddled, perhaps purposely so, as the plaintiffs, claiming only monitoring – meaning the plaintiffs were not yet injured —  tried to bolster their claims by repeatedly pointing to others who actually did suffer physical injury.  The Baker court found enough to get by Rule 12, but it is hard to believe there is enough here to establish a right to monitoring.  The real issue in this case will be whether, after the passage of time, there remains any elevated risk of infection.  We will be, ahem, monitoring this litigation for further developments.