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.

**********

“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. Rondo, 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.

 

This post comes only from the Cozen O’Connor side of the blog.

The MDL court in the Testosterone Replacement Therapy (“TRT”) litigation recently entered summary judgment in favor of a non-US manufacturer that did not distribute in the US, along with its US subsidiary. The judgment ended efforts to hold those two defendants, Besins Healthcare, S.A. and Besins Healthcare Inc., liable under a series of product liability claims for injuries allegedly caused by the use of AndroGel, a TRT product. In re Testosterone Replacement Therapy Prods. Liab. Litig. Coordinated Pretrial Proceedings, 2018 WL 2416239 (N.D. Ill. May 29, 2018).

The court knocked down each of the plaintiffs’ claims in rather short order. Plaintiff’s strict liability and negligent design defect claims fell because plaintiffs had no evidence of a defect. Plaintiffs tried to rely on allegations in the complaint. That doesn’t cut it on summary judgment. Allegations are not evidence:

As the non-moving party, it is plaintiffs’ burden to identify evidence to show why defendants are not entitled to judgment as a matter of law. Because plaintiffs have provided nothing more than quotations from their complaint and from this Court’s order denying the Besins defendants’ motion to dismiss, they have not met their burden.

Id. at *5. A lack of evidence also ended plaintiffs’ manufacturing defect claim: “Plaintiffs present no evidence or argument that AndroGel suffers from a manufacturing defect. Thus the Court considers plaintiffs to have forfeited that negligence theory.” Id. The court entered judgment against plaintiffs’ defect claims.

More interesting was the Court’s rejection of Plaintiffs’ failure to test claim. Plaintiffs relied on an email from an R&D employee at a Besins subsidiary reacting to publications suggesting an association between AndroGel and cardiovascular risks. The employee wrote that “the community should be calling for further study” and that Besins should be “very careful . . . about getting into this discussion” because it might have an “ethical obligation” to conduct such studies as a company that profited from the manufacture of AndroGel. Id. at *2. It’s not surprising that plaintiffs focused on this email.

But they did little else. In fact, plaintiffs’ evidence went no further than the email, which on its own does not establish a failure to test claim. On the other hand, the Besins defendants, who were not distributors of AndroGel in the US, presented actual evidence undermining plaintiffs’ claim. In particular, they relied on the R&D employee’s deposition testimony in which he clarified that Besins did not have the right to conduct testing in the United States. Id. This went unchallenged, and the court found it dispositive:

Plaintiffs have provided nothing to support a contention that the Besins defendants have a duty to conduct safety studies in the United States. To the contrary, the undisputed evidence shows that the Besins defendants cannot do so, and plaintiffs have not attempted to reconcile that evidence with their position.

Id.

The court found other unfixable problems with plaintiffs’ failure to test claim. Plaintiffs presented no evidence that Besins actually failed to test. The R&D employee’s email certainly doesn’t prove that. Plaintiffs also provided no evidence of a proximate causation, making no evidentiary connection between the alleged failure to test and their injuries:

[P]laintiffs have provided no evidence that the Besins defendants’ alleged failure to test proximately caused plaintiffs’ injuries. Plaintiffs’ theory is that the Besins defendants’ failure to adequately test AndroGel caused AbbVie [the company to whom Besins licensed the exclusive right to market and distribute AndroGel in the US] to lack sufficient information about AndroGel’s risks. The alleged failure to test, plaintiffs say, thus “directly contributed to AbbVie’s failure to provide an adequate warning to healthcare providers in the United States.” Plaintiffs, however, do not cite any evidence to support this theory. Their conclusory argument is insufficient to withstand summary judgment.

Id.

The court also rejected plaintiffs’ failure to report adverse reports claim. Plaintiffs described this claim as a failure to report adverse events to other manufacturers, industry experts and the FDA. Having so constructed their claim, however, plaintiffs presented no evidence or argument to establish that the Besins defendants had an enforceable duty to report adverse events to other manufacturers or industry experts. Id. at *6. For their part, the Besins defendants presented evidence that they had no duty to report AndroGel adverse events to the FDA. That responsibility instead fell solely to AbbVie, the company to whom the Besins defendants licensed the exclusive right to market and distribute AndroGel in the US. Id. With no duty, plaintiffs had no claim. Setting that aside, plaintiffs nonetheless presented no evidence that the Besins defendants failed to report any adverse event or that such failure proximately caused their injuries. Id. For all these reasons, the court entered judgment against plaintiffs’ failure to report claim.

The upshot of this opinion appears to be that the non-distributor Besins defendants are our of the Hormone Replacement Therapy MDL.

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.

 

Is fear of injury the same thing as injury?  The question answers itself.  At least it should.  They are not the same, and there are strong jurisprudential reasons for courts to throw out cases alleging mere fear of injury.  We have a No Injury scorecard documenting a pretty clear court consensus that fear of injury should not be enough to get a case to the jury.  Think of diet drug cases where the claim was an increased risk of heart valve injury.  Most courts concluded that such fear did not amount to actionable injury.  Considerations of Article III case or controversy or standing or ripeness usually persuaded courts that fear of physical injury simply did not cut it.  But not always.  So it is good that today’s case, Perez v. B. Braun Medical, Inc., 2018 WL 2316334 (S.D.N.Y. May 9, 2018), gets added to the defense side of the ledger.  In 2010, the plaintiff had been implanted with an IVC filter to treat her pulmonary embolism (PE) and deep vein thrombosis (DVT).  The implant was intended to be permanent.  In subsequent years there were reports of IVC filters causing problems via misalignment and migration.  In 2014, the FDA urged doctors to remove IVC filters within one to two months after the danger of PE subsides.  The plaintiffs alleged that the defendants in this case continued to market their IVC filter for long-term use — according to the court, the complaint alleged that the defendants were “defying the FDA’s general recommendations.”  Meanwhile, no doctor recommended that the plaintiff remove the IVC filter, even though in 2016 a CT scan showed that the tip of the IVC filter possibly had tilted.  That tipping point was apparently not enough to remove the filter, but was enough to file a lawsuit.  The complaint alleged that the IVC filter was defective and increased the risk that the plaintiff would suffer a serious injury. The plaintiff also referenced unspecified economic and psychological damages. The defendants moved to dismiss the complaint for failure to state a claim upon which relief can be granted, arguing that the complaint did not adequately allege that the plaintiff had suffered any cognizable injury.  The court granted the motion to dismiss.  It analyzed the personal injury, warranty, fraud, and New York Business law claims separately, so we will do likewise.

1. Personal Injury Claims

The plaintiff alleged that her physical injuries were the post-implant likely tilting of the IVC filter, psychological trauma of living with a defective product implanted in her body, and the increased risk of future injuries due to the IVC filter.  The problem for the plaintiff was that New York law is reasonably clear that a mere threat of future harm is insufficient to impose liability against a defendant in a tort context.  To be sure, the complaint also alleged that the plaintiff “sustained serious personal injuries,” “serious physical injuries,” and “severe injuries,” that she suffered “loss of enjoyment of life, disability, and other losses,” and that she “incurred substantial medical costs and expenses to treat and care for Plaintiff’s injuries described herein.”  But those are more rote formulas than factual allegations.  The complaint certainly never described the nature of the injuries.  New York law does recognize claims for emotional distress, but such claims must be premised on truly outrageous conduct, and nothing like that resided in the complaint.  Perhaps the best thing that the plaintiff had was an allegation that the defendants marketed permanent filters even after the “FDA warnings that caution generally against long-term implantation of IVC filters.” But because those warnings, whether or not they said what the plaintiff alleged, did not happen until after the plaintiff’s implant, they could not preserve the plaintiff’s claims.

2. Breach of Warranty Claims

The defendants had a strong statute of imitations argument, because the clock on warranty claims usually starts at the time delivery, which was in 2010, more than seven years before the complaint was filed.  New York’s statute of limitations for warranty claims is four years.  The plaintiff trued to dodge the statute of limitations by arguing that the warranty explicitly extended to future performance, and that existed here because the defendants had stated that the IVC filters were safe and effective for permanent implantation.  But the complaint did not explain how the plaintiff’s particular IVC filter had fallen short.  Again, the mere tilting of the IVC filter, even with a risk of future harm, did not equate to a cognizable injury,  New York courts (like most courts on planet Earth) have acknowledged a policy of protecting court dockets from “being clogged with frivolous and unfounded claims.”  Warranty claims often seem like add-ons in product liability cases, and here they were frail add-ons to already frail claims.

3. Fraud Based Claims

Fed. R. Civ. P. 9(b) requires that fraud claims be pleaded with specificity, and the Perez complaint did not come close to meeting this standard.  Again, the plaintiff leaned on the defendants’ representations that the IVC filters were safe and effective for their intended and reasonably foreseeable use.  But the plaintiff never explained why those statements are fraudulent. After all, the the complaint admitted that IVC filters can be used to reduce the risk of PE and DVT, and it nowhere alleges that the plaintiff’s filter performed in a manner different from how the defendants describe.  Whatever the complications and injuries that the defendants failed to warn the plaintiff about, the complaint did not specifically describe them, and could not allege that the plaintiff had sustained any such complications and injuries.  Moreover, the complaint lacked any facts showing that the alleged omissions were made with an intent to deceive.  The plaintiff simply had not made out a case for fraud.

4. New York General Business Law Claim

The complaint’s final count alleged that the defendants engaged in consumer fraud in violation of New York General Business Law Sections 349 and 350<http://www.westlaw.com/Link/Document/FullText?findType=L&pubNum=1000081&cite=NYGBS350&originatingDoc=Ib48241005e2b11e89868e3d0ed3e7ebe&refType=LQ&originationContext=document&vr=3.0&rs=cblt1.0&transitionType=DocumentItem&contextData=(sc.FindAndPrintPortal)>. Section 349 prohibits “[d]eceptive acts or practices in the conduct of any business, trade or commerce or in the furnishing of any service in this state.” Section 350 prohibits “[f]alse advertising.”  As with the plaintiff’s breach of warranty and fraud based claims, the New York Business Law claims failed to show what materially misleading representations the defendants made. That there are side effects associated with IVC filters that are implanted long-term, does not mean that the plaintiff’s IVC filter “had not been effective for implantation into the IVC to prevent PE and DVT for which it was designed or that it is not safer than the alternative.”

What is interesting about the Perez case is how the lack of a real injury did not just undermine the personal injury claims (seems obvious enough), but also undermined the representational claims.  What is doubly interesting about the Perez case is that the no-injury defense worked with respect to an implanted device.  Most of the good cases on our no injury scorecard involved drugs.  Arguably, a plaintiff has a little more to work with when there is a device implanted in the body.  There is a continuing exposure.  Nevertheless, mere fear of injury could not overcome the court’s fear of frivolous claims.

First, we’ve endured MDL courts messing around with Utah law and ignoring the usual congruence in the treatment of prescription drugs and prescription medical devices under Restatement (Second) of Torts §402A, comment k (1965).  We covered that kerfuffle here, here, here, and here.  More recently, the Fifth Circuit in In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Product Liability Litigation, 888 F.3d 753 (5th Cir. 2018), outright refused – based on zero precedent – to predict that Texas would follow the overwhelming majority rule that comment k applies equally to both prescription drugs and medical devices.  Id. at 772.  Texas and Utah are two relatively conservative states when it comes to tort law.  Both have applied comment k “across the board” to prescription drugs.

We don’t think that it’s proper for federal courts, particularly in MDLs, to cut plaintiffs unprecedented breaks on substantive state law and apply comment k less strongly to prescription medical devices than to prescription drugs.  Practically no court has done that – treating prescription drugs and prescription medical devices differently under comment k – before.  Comment k is certainly not limited to prescription drugs.  The comment explicitly references vaccines, something which the United States Supreme Court has recognized.  Bruesewitz v. Wyeth LLC, 562 U.S. 223, 234 (2011).

Moreover, these recent MDL decisions appear to be  a pro-plaintiff one-way street.  Every time, the rulings are that an otherwise “across the board” comment k state (for drugs) would nonetheless apply comment k “case-by-case” to medical devices, even though no state court has done so.  We have yet to see an MDL court take the opposite position, that comment k “across-the-board” is proper for devices in a “case-by-case” state for drugs).  We know what we’re seeing – MDL courts seeking to increase settlement pressure by weaponizing novel state-law issues through pro-plaintiff legal rulings.

Here at the Blog, we’ve never examined how comment k is treated in medical device cases in depth.  Until these recent decisions, the precedent in favor of treating all prescription medical products the same under comment k – whether “same” means across-the-board, or the other (and majority) “case-by-case” application – was virtually unanimous, so we took congruity for granted.  Not any more.  We’re rectifying that situation now.

First, to reiterate, the proposition we’re supporting is, with apologies to generic preemption, “sameness.”  We consider decisions:  (1) applying comment k “across-the-board” to both prescription drugs and devices and, (2) applying comment k “case-by-case” to both prescription drugs and devices, as equivalent in this context – employing “sameness” in applying comment k similarly to all prescription medical products.

We start looking is the Restatement of Torts.  Comment k, obviously, is from the Second Restatement.  The Third Restatement, which was adopted by ALI in 1998, after product liability law became more developed, has a similar, but not identical restriction on design defect claims involving prescription medical products.  But one thing is clear – the same rules apply to all prescription medical products:

(a) A manufacturer of a prescription drug or medical device who sells or otherwise distributes a defective drug or medical device is subject to liability for harm to persons caused by the defect.  A prescription drug or medical device is one that may be legally sold or otherwise distributed only pursuant to a health-care provider’s prescription.

*          *          *          *

(c) A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.

Restatement (Third) of Torts, Products Liability §6(a, c) (1998) (emphasis added).  Thus the Restatement provides strong support for applying the same standards for both prescription drugs and medical devices.

Second, as to whether a state is an “across-the-board” or a “case-by-case” comment k jurisdiction, we rely upon our prior analysis of that question in our 2011 “Comment K Some of the Way” post, except where noted herein (as with Washington State).

Alabama

We considered Alabama to be an “across-the-board” comment k state in 2011. The same standard was applied to medical devices in Emody v. Medtronic, Inc., 238 F. Supp.2d 1291 (N.D. Ala. 2003):

According to [defendant], under [the Alabama Extended Manufacturer’s Liability Doctrine], prescription medical devices are unavoidably unsafe products, and where inherent risks are at issue, the only other permissible theory of liability is inadequate warning.  [Plaintiff] claims that the application of the unavoidably unsafe products doctrine should not apply to an implantable, prescription-only medical device.  The court agrees with [defendant]. The [product] is a prescription-only medical device that has an unavoidably unsafe characteristic.

Id. at 1296. Emody followed Stone v. Smith, Kline, & French Laboratories, 447 So.2d 1301 (Ala.1984), a prescription drug case, and was in turn followed in Cooper v. Bristol-Myers Squibb Co., 2013 WL 85291, at *10 (D.N.J. Jan. 7, 2013) (applying Alabama law), another prescription drug case.

Alabama does not distinguish between prescription drugs and medical devices in applying comment k.

Alaska

Neither does Alaska, but that is because Alaska is one of the few states that – at least a long time ago – refused to adopt comment k altogether.  Shanks v. Upjohn Co., 835 P.2d 1189, 1197-98 (Alaska 1992).  Shanks was a drug case, but we don’t know of any medical device case applying comment k either.

Arizona

We learned in 2011 that Arizona has applied the “case-by-case” approach to both prescription drugs and medical devices.  The first case to address comment k was Gaston v. Hunter, 588 P.2d 326, 340 (Ariz. App. 1978), a drug case.  Gaston has been followed in medical device cases applying Arizona law.  See Miller v. Stryker Instruments, 2012 WL 1718825, at *19 (D. Ariz. March 29, 2012) (prerequisites to comment k not established); Conklin v. Banner Health, 2015 WL 10688305, at *4 (Ariz. Super. Oct. 30, 2015) (prerequisites to comment k established).

However, Arizona now may well adhere to the Third Restatement’s restrictions on design defect claims involving prescription medical products, rather than to comment k.  See Watts v. Medicis Pharmaceutical Corp., 365 P.3d 944, 949 (Ariz. 2016) (adopting Restatement (Third) of Torts, Products Liability §6 (1998)) (prescription drug case); Harrison v. Howmedica Osteonics Corp., 2008 WL 906585, at *21 (D. Ariz. March 31, 2008) (applying Restatement §6 to medical device case); Gebhardt v. Mentor Corp., 191 F.R.D. 180, 185-86 (D. Ariz. 1999) (same), aff’d, 15 F. Appx. 540 (9th Cir. 2001).  Again, the same standard is applied to both prescription drugs and medical devices in Arizona.

Arkansas

As our 2011 post describes, Arkansas courts have adopted a “case-by-case” approach to comment k in prescription drug cases. Predicting Arkansas law, the Eighth Circuit adopted this construction of comment k in a medical device case, Hill v. Searle Laboratories, 884 F.2d 1064, 1067-68 (8th Cir. 1989).  The Arkansas Supreme Court, citing favorably to Hill, took the same approach in West v. Searle & Co., 806 S.W.2d 608, 612-13 (Ark. 1991), a prescription drug case.  Both Hill and West involved contraceptive products.  We haven’t seen an Arkansas device case addressing comment k since, but there’s no reason to believe Arkansas law would apply one way to prescription drugs, and another way to prescription medical devices.

California

As our earlier post discussed at length, California is the epitome of the “across-the-board” approach to comment k.  See Brown v. Superior Court, 751 P.2d 470, 475-83 (Cal. 1988).  Time and again, courts applying California law have likewise applied comment k “across the board” to medical devices.

[W]e find the important considerations underlying Brown apply with equal force to implanted medical devices which, like prescription drugs, are available only through a physician and can save lives or reduce pain and suffering.  Such products are commonly crucial to the well-being of the patient.  Some devices are so important that, as is the case with prescription drugs, the patient faces death without them.  Other devices, such as the intrauterine device, provide important family planning benefits and may have direct or indirect effects on the patient’s physical, mental or emotional health as well. Still other devices . . . serve the salutary purposes of restoring a degree of normalcy to the lives of those who suffer organic dysfunctions and an impaired quality of life. . . .

We perceive the risks attendant to implanted medical devices are akin to those of prescription drugs. Just as drugs and vaccines are injected or ingested into the body, implant devices must be “plugged in” to the individual, to work their effect upon or respond to complex systems imperfectly understood by medical science.  Just as with drugs and vaccines, the result may be dependent upon the peculiar physical characteristics of the individual, as is graphically illustrated in this case. . . .  Thus, when distinctions are made among medical products, implanted medical devices must be placed in a category with prescription drugs. . . .

The Brown court observed that even though a medical product with dangerous side effects may fairly be “characterized” as defectively designed, strict liability should apply only if it would serve the public interest.  We believe the public’s interest in development, availability and affordability of medical devices demands rejection of strict liability and adoption of the comment k standard.  As with prescription drugs, the harsher rule of strict liability may discourage manufacturers from researching and marketing new medical devices due to realistic fear of substantial adverse judgments, the high cost of strict liability insurance and the uncertainty that such insurance will even be available.  The costs involved may well place the products beyond the reach of those who need [them] most.  Public interest is served, rather than thwarted, by relieving the manufacturer of strict liability for injuries resulting from implanted medical devices that have been properly fabricated and marketed.

Hufft v. Horowitz, 5 Cal. Rptr. 2d 377, 383-84 (Cal. App. 1992) (citations and quotation marks omitted).

[T]he entire category of medical implants available only by resort to the services of a physician are immune from design defect strict liability.  There is no contention anywhere in the record of these coordinated cases that any of the [devices], the subject of the various claims, were obtained other than by the services of a physician.  Therefore, the determination that strict liability based on design defect is unavailable for all such claims is one to be made as a matter of law, and without the benefit of any factfinding, except for the sole factual determination, made without dispute in these cases, that the [devices] are all physician-directed and physician-applied.  Summary adjudication was therefore appropriate.

Artiglio v. Superior Court, 27 Cal. Rptr. 2d 589, 593-94 (Cal. App. 1994). Accord Garrett v. Howmedica Osteonics Corp., 153 Cal. Rptr.3d 693, 701 (Cal. App. 2013) (“the reasoning of Brown and Hufft applies to an implanted medical device . . .  regardless of whether, strictly speaking, it was available only by prescription and regardless of whether it is properly characterized as a ‘prescription’ implanted medical device”) (citations omitted); Plenger v. Alza Corp., 13 Cal. Rptr.2d 811, 818 (Cal. App. 1992) (“[w]e as well are unable to make any principled distinction in terms of policy considerations between prescription drugs and prescription implanted medical devices”); Paturzo v. Boston Scientific Corp., 2017 WL 8220600, at *3 (C.D. Cal. April 21, 2017) (“California law does not permit strict liability claims for design defects of implanted medical devices”; “the standard of liability in that context is the ‘comment k’ standard”) (citation omitted); Markowitz v. Davol, Inc., 2015 WL 12696031, at *2 (C.D. Cal. June 19, 2015) (“similar to prescription drugs, public interest favors the development, availability and affordability of such implanted medical devices”); Anderson v. Medtronic, Inc., 2015 WL 2115342, at *7 (S.D. Cal. May 6, 2015) (“to the extent these claims allege strict liability based on a design defect, they are barred by Comment K”); Sukonik v. Wright Medical Technology, Inc., 2015 WL 10682986, at *10 (C.D. Cal. Jan. 26, 2015) (a plaintiff may not maintain a strict liability claim against the manufacturer of an implanted prescription medical device on the basis of an alleged design defect”); Tucker v. Wright Medical Technology, Inc., 2013 WL 1149717, at *5 (N.D. Cal. March 19, 2013) (“the unavoidably unsafe defense set forth in Comment k act[s] as a complete bar to Plaintiffs’ strict liability design defect claim”); Currier v. Stryker Corp., 2011 WL 4898501, at *2 (E.D.Cal. Oct.13, 2011) (“California law prohibits strict liability claims for design defect against manufacturers of prescription implantable medical devices”); Mitchell v. Acumed LLC, 2011 WL 2433038, at *4 (N.D. Cal. June 13, 2011) (“it has long been the law that implanted medical devices are exempted from strict liability for design defects”); Rhynes v. Stryker Corp., 2011 WL 2149095, at *7 (N.D.Cal. May 31, 2011) (“California law categorically protects manufacturers of prescription medical devices from strict liability for design defects”); Adams v. I-Flow Corp., 2010 WL 1339948, at *6 (C.D.Cal. March 30, 2010) (“design defect theories of products liability . . . are unequivocally barred by California law”); In re Guidant Corp. Implantable Defibrillators Products Liability Litigation, 2007 WL 1725289, at *18 (D. Minn. June 12, 2007) (“California exempts manufactures of prescription drugs and medical devices from design defect claims”) (applying California law); Yalter v. Endocare, Inc., 2004 WL 5237598, at *4 (C.D. Cal. Nov. 8, 2004) (“prescription drugs and medical devices are considered to be unavoidably unsafe products”), aff’d, 220 F. Appx. 657 (9th Cir. 2007); Hanohano v. Uppal, 1997 WL 33426414, at *1 (Cal. Super. June 3, 1997) (“[u]nder Comment k, manufacturers of implanted medical devices cannot be strictly liable for design defects”). See also Sanchez v. Boston Scientific Corp., 38 F. Supp.3d 727, 736 (S.D.W. Va. 2014) (“California does not recognize strict liability for defective design of implantable medical devices”) (applying California law); Centeno v. Bayer Healthcare Pharmaceuticals, Inc., 2014 WL 4809565, at *4 (S.D. Ill. Sept. 26, 2014) (“To the extent that plaintiff seeks recovery in strict liability for design defects, her . . . Cause of Action is not cognizable under California law”) (applying California law).

Further, as discussed at length here, California (and other states’) law does not require an “implanted” device to apply comment k across the board.  In Armstrong v. Optical Radiation Corp., 57 Cal. Rptr.2d 763, 772 (Cal. App. 1996), a case involving “a thick, transparent jelly-like fluid” that is “a surgical aid,” the court applied comment k and held:

[W]e note that California law precludes strict liability for a design defect in a medical device. In the context of medical devices, design defects must be pursued under a negligence theory.

Id. at 772 (citation omitted).

As we complained above, the only contrary decision comes from an MDL, where state law was improperly manipulated as a settlement tool. See In re DePuy Orthopaedics, Inc. Pinnacle Hip Implant Products Liability Litigation, 2016 WL 9559961, at *2-3 (N.D. Tex. Sept. 20, 2016) (ignoring “several decisions from California’s intermediate appellate courts”; creating distinction between different FDA classes of medical devices despite numerous California cases applying comment k to both Class II and Class III devices).

Colorado

Our 2011 post assigned Colorado to the “case-by-case” approach.  As to medical devices, Wollam v. Wright Medical Group, Inc., 2012 WL 45106955 (D. Colo. Sept. 30, 2012), applied the same case-by-case method to medical devices:

In asserting this defense, [defendant] bears the burden of establishing that the [device’s]“utility must greatly outweigh the risk created by its use, the risk must be a known one; the product’s benefits must not be achievable in another manner; and the risk must be unavoidable under the present state of knowledge.”

Id. at *5.  Wollam relied on a couple of prior cases involving neither drugs nor devices, but blood products.  In Hawkinson v. A.H. Robins Co., 595 F. Supp. 1290 (D. Colo. 1984), involving a pre-MDA medical device, the court similarly held, “to rely on comment k, a manufacturer must show that the product was properly prepared, and properly marketed, accompanied by appropriate warnings and directions for use.”  Id. at 1308.

However, the most recent decision out of Colorado, Haffner v. Stryker Corp., 2014 WL 4821107 (D. Colo. Sept. 29, 2014), applied Restatement Third §6, rather than comment k, so it is open to question which standard is currently Colorado law.  Id. at *3.  In no instance has a distinction been drawn between prescription drugs and prescription medical devices.

Connecticut

While not addressing the “across-the-board”/”case-by-case” distinction directly the Connecticut Supreme Court in Vitanza v. Upjohn Co., 778 A.2d 829, 837 (Conn. 2001), held that “the policy considerations contained in comment (k) to §402A are persuasive and are in accord with this state’s product liability jurisprudence.”  In Hurley v. The Heart Physicians, P.C., 898 A.2d 777, 783 (Conn. 2006), the court applied the same policies to a prescription medical device.

In Vitanza, we adopted comment (k) to § 402A of the Restatement (Second) of Torts, concluding that the policy considerations set forth therein are persuasive and in accord with this state’s product liability jurisprudence. . . .  Numerous courts have determined that they [policy considerations] are applicable to prescription medical device cases.

Id. at 784 (citations and quotation marks omitted).  See also Breen v. Synthes-Stratec, Inc., 947 A.2d 383, 388 (Conn. App. 2008) (“under Connecticut law, comment (k) is not limited to prescription drugs but also is applicable to medical devices”).  Notably, Breen also “decline[d],

to accept the plaintiff’s invitation to draw a bright line distinction between class II and class III medical devices in determining the applicability of comment (k). . . .  The plaintiff has failed to provide any persuasive reason why a blanket rule excepting all class II medical devices from the application of these doctrines is appropriate or necessary.  Indeed, beyond the plaintiff’s mere reference to the portion of the definition of a class III device, . . . the plaintiff has failed to explicate his argument as to why only class III devices should fall within the ambit of comment (k). . . .  Moreover, the plaintiff has not cited any cases in which such a distinction has been applied, and we decline to draw a distinction here.

Id. at 390 (citations and quotation marks omitted).  For other Connecticut cases applying comment k to medical devices, see:  Allen v. Mentor Corp., 2006 WL 861007, at *7 (D. Conn. March 31, 2006) (applying comment k to medical device); Ferrari v. Johnson & Johnson, Inc., 2017 WL 6389870, at *4 (Conn. Super. Nov. 28, 2017) (observing that Hurley “extended” comment k to prescription medical devices); Wegryn v. Smith & Nephew, Inc., 2008 WL 803405, at *3 (Conn. Super. March 5, 2008) (“there is no persuasive reason to distinguish between a prescription implantable medical device and prescription drugs when raising . . . Section 402A, of the Restatement (Second) of Torts comment (k)”); see also Havanick v. C. R. Bard, Inc., 2016 WL 7116138, at *3-4 (S.D.W. Va. Dec. 6, 2016) (“Connecticut courts consider comment k as a defense against strict liability to manufacturers of medical device companies”) (applying Connecticut law).

Delaware

Delaware has never adopted strict liability or Restatement (Second) of Torts §402A (1965).  Thus, the comment k question cannot arise.

District of Columbia

We put the District in the “across-the-board” category in 2011 due to the lack of any “case-by-case” adjudication in this jurisdiction’s case law.  Both then, and now, there is no medical device precedent in the District, however, the unavoidably unsafe product doctrine has been applied in the same fashion to blood products.  Fisher v. Sibley Memorial Hospital, 403 A.2d 1130, 1134 (D.C. 1979); Kozup v. Georgetown University, 663 F. Supp. 1048, 1058-59 (D.D.C. 1987), aff’d in pertinent part, vacated on other grounds, 851 F.2d 437 (D.C. Cir. 1988).  There is no basis to conclude that medical devices would be treated any differently.

Florida

We considered Florida law comment k law unsettled in 2011, but since then most of the cases have utilized a “case-by-case” approach.  One thing that is not unsettled, however, is that whatever Florida law is, it applies to prescription drugs and medical devices equally.  “Florida courts apply the basic elements of a strict liability claim with equal force to medical device and prescription drug manufacturers.” Bailey v. Janssen Pharmaceutica, Inc., 288 F. Appx. 597, 607 (11th Cir. 2008) (applying Florida law).  Bailey, a drug case, cited and followed Adams v. G.D. Searle & Co., 576 So.2d 728 (Fla. App. 1991), which involved a medical device.  Adams applied a “case-by-case” approach. Id. at 733 (“We therefore reject a blanket approach and decline to apply comment k to all prescription products.  Instead, we follow those courts which hold that comment k is an affirmative defense to a strict liability claim.”).

Other Florida law cases have applied comment k to medical devices in a similar fashion.  Tillman v. C.R. Bard, Inc., 96 F. Supp.3d 1307, 1341 (M.D. Fla. 2015) (following Adams; “[t]o receive the protection of comment k, [defendant] must show that ‘the product is as safe as current testing and research permit” at the time of distribution’”); Byrnes v. Small, 60 F. Supp.3d 1289, 1299 (M.D. Fla. 2015) (following Adams; “[c]omment k . . . has been adopted by Florida courts as an affirmative defense to a strict products liability claim for medical devices”); Ocasio v. C.R. Bard, Inc., 2015 WL 3496062, at *5-6 (M.D. Fla. June 3, 2015) (following Adams); Brady v. Medtronic, Inc., 2014 WL 1377830, at *6 (S.D. Fla. April 8, 2014) (the device “is an unavoidably unsafe product that falls within the purview of comment k”); Mardegan v. Mylan, Inc., 2012 WL 12850781, at *6-7 (S.D. Fla. Jan. 31, 2012) (following Adams; transdermal patch with attributes of both a drug and a medical device); Duncan v. Iolab Corp., 1991 WL 544617, at *1 (M.D. Fla. Nov. 18, 1991) (applying comment k to bar strict liability against medical device), aff’d, 12 F.3d 194 (11th Cir. 1994).

Georgia

In 2011, we had Georgia as trending towards “case-by-case” application of comment k.  None of the cases we cited involved medical devices, and no new decision does so either.  The most in-depth discussion of comment k occurred in Bryant v. Hoffmann-La Roche, Inc., 585 S.E.2d 723, 726-28 (Ga. App. 2003), and we think it’s significant that Bryant relied on cases involving prescription drugs, prescription medical devices, and prescription vaccines, without drawing any distinctions between them.

Hawaii

Hawaii applied comment k on a “case-by-case” basis to a medical device in Larsen v. Pacesetter Systems, Inc., 837 P.2d 1273 (Haw. 1992), finding a device that had “many different types” on the market was “sufficiently analogous to a new and experimental drug to warrant comment k exemption from strict products liability.”  Id. at 1286.  Since 2011Larsen’s approach was likewise applied to prescription drugs under Hawaii law.  Segovia v. Bristol-Myers Squibb Co., 2016 WL 1587220, at *4-5 (D. Haw. April 19, 2016); Forsyth v. Eli Lilly & Co., 1998 WL 35152135, at *3-4 (D. Haw. Jan. 5, 1998).  Once again, there is no precedent for treating prescription drugs and prescription medical devices differently under comment k.

Idaho

As we discussed at length in our 2011 post, Idaho was the poster child for the “case-by-case” approach.  The case that made it so, however, Toner v. Lederle Laboratories, 732 P.2d 297 (Idaho 1987), was not a prescription drug case, but instead involved a vaccine.  Only recently, was the first Idaho law case involving a medical device decided.  See Hepburn v. Boston Scientific Corp., 2018 WL 2275219 (D. Idaho May 17, 2018).  Not surprisingly, Hepburn applied Toner’s construction of comment k to medical devices.  Id. at *6.

Illinois

In 2011, we concluded that Illinois was a “case-by-case” state for comment k purposes.  That is just as true for medical devices as for drugs.  The earliest decision to apply comment k, Greenberg v. Michael Reese Hospital, 415 N.E.2d 390 (Ill. 1980), contained a lengthy policy discussion before concluding that “public policy dictates against the imposition of strict liability in tort for injuries resulting from the administration of X-radiation treatments.”  Id. at 393-95.  See also:  Mele v. Howmedica, Inc., 808 N.E.2d 1026, 1042 (Ill. App. 2004) (Illinois . . . require[s] trial courts to determine on a case-by-case basis whether any medical device or other product qualifies as unavoidably dangerous”); Huskey v. Ethicon, Inc., 848 F.3d 151, 157-58 (4th Cir. 2017) (“under Illinois law, courts determine ‘on a case by case basis’ if a particular product falls within comment k”) (applying Illinois law).  Huskey cited an Illinois prescription drug case, Glassman v. Wyeth Laboratories, Inc., 606 N.E.2d 338, 342 (Ill. App. 1992), finding no difference between drugs and devices for comment k purposes.

Indiana

In 2011, we noted confusion in Indiana comment k jurisprudence, with courts going both ways – all in cases involving prescription drugs.

Citing the “dearth” of decisions concerning “dangers in the use of medical devices,” the Seventh Circuit “f[ou]nd no principled basis for such a distinction” between the two types of prescription medical products in Phelps v. Sherwood Medical Industries, 836 F.2d 296, 299, 303 (7th Cir. 1987) (applying Indiana law).  Phelps, however, did not directly address comment k.  In Parks v. Danek Medical, Inc., 1999 WL 1129706 (N.D. Ind. June 17, 1999), the court analogized to those cases applying the “across the board” approach:

[S]trict liability design claims for “unavoidably unsafe” products are barred, pursuant to the Restatement (Second) of Torts §402A cmt. k (1965).  “The legal effect of finding a product to be ‘unavoidably unsafe’ under comment k is that a plaintiff may recover based on improper or negligent preparation or inadequate warning, but not on the basis that the design of the product was defective.”  Unavoidably unsafe products include prescription drugs.  It is undisputed that the device at issue was available only by prescription and comment k has been held to apply to prescription medical devices, as well as to prescription drugs.

Id. at *6 (citing Phelps; other citations and footnote omitted).  Cf. McAfee v. Medtronic, Inc., 2015 WL 3617755, at *3 (N.D. Ind. June 4, 2015) (plaintiff essentially conceded comment k barring strict liability warning claim), on reconsideration on other grounds, 2016 WL 2588807 (N.D. Ind. May 5, 2016).

Iowa

As we pointed out in 2011, Iowa appellate authority had applied comment k without case-specific risk/benefit balancing in cases involving both prescription drugs, Moore v. Vanderloo, 386 N.W.2d 108, 116 (Iowa 1986), and vaccines, Petty v. United States, 740 F.2d 1428, 1439 (8th Cir. 1984).  In addition to those cases, Iowa law had applied the “unavoidably unsafe” principle to an over-the-counter medical device, a tampon . See Kehm v. Procter & Gamble Manufacturing Co., 724 F.2d 613, 621 (8th Cir. 1983) (“where the product is inherently unavoidably unsafe, liability hinges on the adequacy of the warning to users, an issue which, like negligence in non-products cases, turns on the reasonableness of the defendant’s responses to foreseeable dangers”) (applying Iowa law).

We still haven’t found an Iowa law case applying comment k/unavoidably unsafe to a prescription medical device, but we have no reason to believe such devices would be treated differently than the other types of medical products, prescription and otherwise, to which this principle has been applied.

Kansas

In 2011, we concluded Kansas was a “case by case” jurisdiction for comment k.

Kansas courts appear to have applied this comment k standard identically to medical devices and vaccines, in addition to prescription drugs.  See Humes v. Clinton, 792 P.2d 1032, 1039 (Kan. 1990) (applying unavoidably unsafe exception to medical device); Johnson v. American Cyanamid Co., 718 P.2d 1318, 1323-24 (Kan. 1986) (same, vaccine); Graham v. Wyeth Laboratories, 906 F.2d 1399, 1406 (10th Cir. 1990) (same; vaccine) (applying Kansas law); Graham v. Wyeth Laboratories, 666 F. Supp. 1483, 1496-97 (D. Kan. 1987) (earlier ruling in same case).   We see no basis under Kansas law for disparate standards depending on the type of prescription medical product.

Kentucky

In 2011, Kentucky appeared to be moving away from early precedent suggesting “case-by-case” application of comment k to a broader approach.  The critical case involved prescription drugs, Larkin v. Pfizer, Inc., 153 S.W.3d 758, 761, 770 (Ky. 2004), in which Kentucky adopted both comment k and the Third Restatement’s version of the learned intermediary rule.  Since Larkin repeated the Third Restatement’s equivalence between “drugs” and “medical devices” several times, id. at 761-62, 763, taking the decision at its word indicates that these two types of prescription medical products are to be treated the same.  We’re not sure any longer about Kentucky backsliding from “case by case,” but we are pretty sure that the same standards apply to both prescription drugs and medical devices.

In Prather v. Abbott Laboratories, 960 F. Supp.2d 700 (W.D. Ky. 2013), the court answered this question affirmatively:

At issue is whether . . . a prescription medical device, is within comment k’s purview.  As stated in the comment, unavoidably unsafe products “are especially common in the field of drugs.”  Though that may be the case, comment k certainly does not foreclose the possibility of extending its reach to medical devices.  Rather, comment k operates when the product at issue is unavoidably unsafe − that is, it is both useful and desirable, but marked by a known, reasonable risk.

*          *          *          *

The Court does not discern a meaningful difference between this device and a prescription drug, and does not believe the framers of comment k would exclude such a product.  [It] is highly useful and desirable product used for postoperative pain management.  As will be discussed, to the extent scientifically knowable at the time, the risk of injury posed by the [device] was marginal.  Therefore, the Court finds that the [device is within the ambit of comment k.

Id. at 707 (numerous citations omitted).  Prather went on to apply the same “case by case” approach previously used with prescription drugs.  Id. (citing Weiss v. Fujisawa Pharmaceutical Co., 2006 WL 3533072, at *3 (E.D. Ky. Dec. 7, 2006)).  See also Clark v. Danek Medical, Inc., 1999 WL 613316, at *4 (W.D. Ky. March 29, 1999) (“Plaintiffs’ claims are most appropriately considered in that [comment k] context”).

Louisiana

Although Louisiana courts had not discussed comment k in such terms, their application looked like “across-the-board” to us in 2011.

The only case directly applying comment k to Louisiana law is questionable precedent indeed, since the opinion in McPheron v. Searle Laboratories, Inc., 888 F.2d 31 (5th Cir. 1989), certified the question to the Louisiana Supreme Court, but was later vacated on grounds that sounded like a settlement.  See McPheron v. Searle Laboratories, 904 F.2d 251 (5th Cir. 1990).  Bearing that in mind, the Fifth Circuit in McPheron stated:

{Plaintiff] contends that the court below erred in applying this doctrine to [a medical device that] is not a “true” prescription drug, which is taken into and absorbed by the body.  The great weight of the authority in other jurisdictions is to the contrary. . . .  The minority view is that the question of whether a prescription medical device is an unavoidably unsafe product entitled to comment k protection is a question of fact for the jury.

Id. at 33 (citations omitted).  At least, that’s what the Fifth Circuit thought in 1989.  We’ve not seen a Louisiana law case involving comment k and medical devices since.

Also indicative that there are no differences in the application of comment k to various prescription medical products is Chauvin v. Sisters of Mercy Health Systems, Inc., 818 So. 2d 833 (La. App. 2002), which “strongly agree[d] with the need to consider comment k and the ‘unavoidably unsafe’ defense” in a blood products case.  Id. at 840.   Accord Bourque v. Louisiana Health Systems Corp., 956 So. 2d 60, 65 (La. App. 2007) (“agree[ing] with . . .  the reasons enunciated in Chauvin”) (blood product case).

Maine

We viewed Maine as “wobbly” in the “case-by-case” approach back in 2011, chiefly on the discussion in Violette v. Smith & Nephew Dyonics, Inc., 62 F.3d 8, 13 n.3 (1st Cir. 1995) (applying Maine law), a medical device case.  A similar result was reached in a drug case in Doe v. Solvay Pharmaceuticals, Inc., 350 F. Supp. 2d 257, 267-68 (D. Me. 2004), aff’d, 153 F. Appx. 1, 2005 WL 2837538 (1st Cir. 2005), which also relied on the Third Restatement.  No reason exists to think Maine would apply comment k differently to prescription drugs than to medical devices.

Maryland

Mostly on the basis of the Court of Appeals’ language in Miles Laboratories, Inc. v. Doe, 556 A.2d 1107 (Md. 1989), a blood products case, we concluded in 2011 that Maryland applied comment k “across the board.”  Id. at 1121 (citing “the singular medical utility” of such products generally).  See also Doe v. Miles Laboratories, Inc., 927 F.2d 187, 191-93 (4th Cir. 1991) (likewise applying comment k in blood product case).

However, several Maryland law cases since then have weighed in on the side of “case-by-case.”  Allen v. Boston Scientific Corp., 2015 WL 5838511, at *3 (S.D.W. Va. Oct. 5, 2015) (applying Maryland law); Stidham v. Boston Scientific Corp., 2015 WL 2452984, at *4 (S.D.W. Va. May 22, 2015) (applying Maryland law); Grinage v. Mylan Pharmaceuticals, Inc., 840 F. Supp.2d 862, 869 n.5 (D. Md. 2011) (generic drug).

There is no indication in any of these cases that Maryland law would apply different standards to different types of prescription medical products.

Massachusetts

“Massachusetts court decisions have consistently hewed to the letter of comment k.”  Tersigni v. Wyeth-Ayerst Pharmaceuticals, Inc., 2014 WL 7464759, at *1 (D. Mass. June 25, 2014).  Massachusetts was another “wobbly” “across-the-board” state in 2011, based in part on Lareau v. Page, 840 F. Supp. 920 (D. Mass. 1993), aff’d, 39 F.3d 384 (1st Cir. 1994), a medical device (contrast dye) case, that applied comment k and unavoidably unsafe doctrine without individualized adjudication. Id. at 933.  The same rather wobbly approach, without case-specific adjudication, was applied to a prescription biologic in Calisi v. Abbott Laboratories, 2013 WL 5441355, at *15 (D. Mass. Sept. 27, 2013).  Cf. Nickerson v. G.D. Searle & Co., 900 F.2d 412, 422 (1st Cir. 1990) (pre-trial defense reliance on comment k was not an “admission” that medical devices were unavoidably unsafe).

Michigan

Based on a very small sample of one case, we thought Michigan was an “across-the-board” state in 2011.  Since then, a similarly small sample of one case, Michigan law was applied in a manner that looks more “case-by-case” in Davis v. C.R. Bard, Inc., 2012 WL 6082933, at *8 (E.D. Mich. Dec. 6, 2012), an medical device case.

Based on more thorough investigation, we’re not sure Davis is accurate, though, since in Antcliff v. State Employees Credit Union, 327 N.W.2d 814, 821 n.10 (Mich. 1982), the Michigan Supreme Court referred prescription drugs as a class as “an unavoidably unsafe product.”  See also Dunn v. Lederle Laboratories, 328 N.W.2d 576, 579 (Mich. App. 1982) (declaring vaccine to be “an unavoidably unsafe product” without case-by-case evaluation).

Minnesota

Unusually, for most states, Minnesota’s comment k law developed mostly in the context of medical devices.  As the law appeared in 2011, Minnesota was a “case-by-case” state.  Kociemba v. G.D. Searle & Co., 680 F. Supp. 1293, 1300-01 (D. Minn. 1988) (involving pre-Medical Device Amendments medical device); see Woodard v. Stryker Corp., 2012 WL 12860868, at *7 (D. Wyo. Feb. 9, 2012) (submitting comment k inquiry to the jury under Kociemba) (applying Minnesota law); Johnson v. Zimmer, Inc., 2004 WL 742038, at *8 nn.5-6 (D. Minn. March 31, 2004) (citing to both comment k and the Restatement Third).

The same “case-by-case” approach has been applied in Minnesota prescription drug product liability cases. Schedin v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 776 F. Supp.2d 907, 914 (D. Minn. 2011).  Once again, there is no reason to believe that comment k is applied differently to different types of products.

Mississippi

Mississippi was a “case-by-case” jurisdiction in 2011.

A very early Mississippi law case also applied this approach to vaccines.  Alman Brothers Farms & Feed Mill v. Diamond Laboratories, Inc., 437 F.2d 1295, 1302-03 (5th Cir. 1971) (applying Mississippi law).  We haven’t seen a Mississippi case on comment k and medical devices, but we see no basis for treating them differently under the law.

Missouri

In 2011, we classified Missouri as a “case-by-case” state.

That includes medical devices.  Racer v. Utterman, 629 S.W.2d 387, 393 (Mo. App. 1981) (“On the record before us we find the surgical drape here to be an “unavoidably unsafe” product.  It is a highly useful product. . . .”); Joyce v. Davol, Inc., 2016 WL 775183, at *2-3 (E.D. Mo. Feb. 29, 2016) (finding comment k to be an affirmative defense in medical device case); In re NuvaRing Products Liability Litigation, 2013 WL 3716389, at *9 (E.D. Mo. July 12, 2013) (finding comment k defense not established on case-by-case analysis).  Cf. Kirsch v. Picker International, Inc., 753 F.2d 670, 671 (8th Cir. 1985) (applying learned intermediary rule to medical devices because “[p]rescription drugs and [this device] are marketed in similar fashion”) (applying Missouri law).

Montana

Back in 2011 we found only one prescription medical product/comment k case in the history of Montana law – from 1968 that applied the unavoidably unsafe defense without considering case-specific facts. Davis v. Wyeth Laboratories, Inc., 399 F.2d 121, 129 (9th Cir. 1968).

That’s still the case today.  We have no reason to believe that prescription medical devices – or prescription drugs for that matter – will be treated differently than vaccines for comment k purposes.

Nebraska

Nebraska is another “case-by-case” jurisdiction.  Freeman v. Hoffman-La Roche, Inc., 618 N.W.2d 827, 835-40 (Neb. 2000).  In its lengthy discussion, Freeman cited cases from other jurisdictions involving both prescription drugs and medical devices without distinguishing between those types of products.  The unavoidably unsafe doctrine has also been employed by Nebraska courts in medical device cases.  See Uribe v. Sofamor, S.N.C., 1999 WL 1129703, at *13 (D. Neb. Aug. 16, 1999).  There’s nothing new since 2011, and no reason to expect Nebraska courts to draw such distinctions going forward.

Nevada

The splintered decision in Allison v. Merck & Co., 878 P.2d 948 (Nev. 1994), as we discussed in more detail in 2011, makes it unclear whether, let alone how, Nevada applies comment k.  A footnote, citing comment k, but not discussing it in any detail, in Klasch v. Walgreen Co., 264 P.3d 1155, 1158 n.7 (Nev. 2011), provides some basis to believe that comment k could reappear, but so far that hasn’t happened.

There sure hasn’t been anything approaching a comment k discussion in a medical device case since Allison – suggesting that prescription drugs and medical devices rise or fall together on this issue.

New Hampshire

Since we wrote our post in 2011 the United States Supreme Court has declared, “New Hampshire takes a case-by-case approach to comment k.”  Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472, 505 (2013) (generic drug case).  That was essentially what we had thought before.

We haven’t seen a medical device/comment k case under New Hampshire law, but we have no reason to suspect that a different standard applies.

New Jersey

As we pointed out in 2011, by statute, it is now a complete defense (“shall not be liable”) that “[t]he harm was caused by an unavoidably unsafe aspect of the product and the product was accompanied by an adequate warning.”  N.J.S.A. 2A:58C-3(a)(3).

The statute draws no distinctions between prescription drugs and medical devices.  See Perez v. Wyeth Laboratories Inc., 734 A.2d 1245, 1251 (N.J. 1999) (statute applied; using “terminology relevant to prescription drugs” even though product was “a hybrid prescription medical device”).  It has been applied in medical device cases. See In re Panacryl Sutures Product Liability Cases, 263 F.R.D. 312, 319 (E.D.N.C. 2009) (applying New Jersey law).

New Mexico

We discussed in 2011 that comment k was applied with no case-specific analysis in Jones v. Minnesota Mining & Manufacturing Co., 669 P.2d 744, 759-60 (N.M. App. 1983), and Perfetti v. McGahn Medical, 662 P.2d 646, 649-50 (N.M. App. 1983), both medical device cases.

Both of these decisions were relied on extensively in Rimbert v. Eli Lilly & Co., 577 F. Supp. 2d 1174, 1201-04 (D.N.M. 2008), a prescription drug case.  So there doesn’t seem to be any basis for applying different tests to different types of prescription products in New Mexico.

New York

As discussed in our 2011 post, New York has never required “case-by-case” adjudication of the applicability of comment k to prescription medical products.  See, e.g., Martin v. Hacker, 628 N.E.2d 1308, 1311 (N.Y. 1993) (“even though its side effects may cause injury, a prescribed drug, accompanied by adequate warnings, is ‘not defective, nor is it unreasonably dangerous’”) (quoting comment k).  The Second Circuit applied comment k to a medical device in Bravman v. Baxter Healthcare Corp., 984 F.2d 71, 76 (2d Cir. 1993) (applying New York law):

The district court, however, was correct in dismissing [plaintiff’] product and design defect claims.  [Plaintiff] contends that the district court dismissed these claims because it had erroneously concluded that the [medical device] is an “unavoidably unsafe” product.  Unavoidably unsafe products are those that “in the present state of human knowledge, are quite incapable of being made safe for their intended ordinary use.”  Restatement (Second) of Torts § 402A cmt. k (1979).  Under New York law, unavoidably unsafe products “are not deemed defective or unreasonably dangerous so long as they are accompanied by proper directions for use and adequate warnings as to potential side effects.”

Id. at 75-75 (quoting Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87, 90 (2d Cir. 1980) (prescription drug case)).  See Militrano v. Lederle Laboratories, 769 N.Y.S.2d 839, 846-47 (N.Y. Sup. 2003) (applying comment k across-the-board in vaccine case), aff’d, 810 N.Y.S.2d 506 (N.Y. App. Div. 2006).

Here we run into see some slippage at the trial court level, as pro-plaintiff courts have partially subverted New York law by not enforcing comment k at the pleading stage.  Williamson v. Stryker Corp., 2013 WL 3833081, at *7-8 (S.D.N.Y. July 23, 2013) (refusing to follow Bravman; design defect claim survives because plaintiff pleaded failure to warn); Henson v. Wright Medical Technology, Inc., 2013 WL 1296388, at *7 (N.D.N.Y. March 28, 2013) (warning claim precludes comment k dismissal on pleadings); cf. Gensler v. Sanofi-Aventis, 2009 WL 857991, at *6 (E.D.N.Y. March 30, 2009) (same dodge with prescription drug).  The slippage however, is not peculiar to medical devices, just as the appellate authority applying comment k “across-the-board” comes from both prescription drug and medical device product liability litigation.

North Carolina

As discussed in 2011, comment k is not an issue in North Carolina because strict liability is statutorily barred.  N.C. Gen. Stat. §99B-6(d).

North Dakota

What little law that exists in North Dakota on comment k/unavoidably unsafe suggests that comment k is to apply on a “case by case” basis – both now, and in 2011.

Ohio

As we indicated in 2011, an Ohio statute mandates application of the unavoidably unsafe doctrine to all drugs and medical devices across the board.  Ohio Rev. Code. §2307.75(D) (“An ethical drug or ethical medical device is not defective in design or formulation because some aspect of it is unavoidably unsafe, if the manufacturer of the ethical drug or ethical medical device provides adequate warning and instruction).”  “Unavoidably unsafe” means “that, in the state of technical, scientific, and medical knowledge at the time a product in question left the control of its manufacturer, an aspect of that product was incapable of being made safe.”  Ohio Rev. Code § 2307.71(A)(16).  See Aaron v. Medtronic, Inc., 209 F. Supp.3d 994, 1014 (S.D. Ohio 2016) (“Plaintiffs’ strict liability claims are barred . . . due to the fact that [the device] is an ‘unavoidably unsafe product’”); Yanovich v. Sulzer Orthopedics, Inc., 2006 WL 3716812, at *11 (N.D. Ohio Dec. 14, 2006) (“an adequate warning is a defense to design defect claims”), aff’d, 255 F. Appx. 957 (6th Cir. 2007) but see Thompson v. DePuy Orthopaedics, Inc., 2015 WL 7888387, at *15 (S.D. Ohio Dec. 4, 2015) (“not all prescription medical devices are deemed unavoidably unsafe”; requiring “no alternative design which would have as effectively accomplished the same purpose or result with less risk”).

Before the statute, Ohio common law had applied comment k in a “case-by-case” fashion.  Once again, however, it did so to all prescription medical products, without exception:

[W]e hold that a prescription drug, vaccine, or like product is not “unavoidably unsafe” per se under Comment k to Section 402A. . . .   Whether such a product qualifies as “unavoidably unsafe” under Comment k is a determination to be made on a case-by-case basis.

White v. Wyeth Laboratories, Inc., 533 N.E.2d 748, 752 (Ohio 1988) (emphasis added) (vaccine case); see Burwell v. American Edwards Laboratories, 574 N.E.2d 1094, 1098 (Ohio App. 1989) (court properly “determined that the [medical device] belonged in the category of unavoidably unsafe products”) (relying on prescription drug cases).

Oklahoma

Several medical device cases supported our 2011 conclusion that Oklahoma was a “case-by-case” comment k state.  See Edwards v. Basel Pharmaceuticals, 933 P.2d 298, 300 (Okla. 1997) (patch); Tansy v. Dacomed Corp., 890 P.2d 881, 885-86 (Okla. 1994) (implant); McKee v. Moore, 648 P.2d 21, 24 (Okla. 1982) (IUD).  See also Littlebear v. Advanced Bionics, LLC, 896 F. Supp.2d 1085, 1092 (N.D. Okla. 2012); Reed v. Smith & Nephew, Inc., 527 F. Supp.2d 1336, 1354 (W.D. Okla. 2007); Alexander v. Smith & Nephew, P.L.C., 98 F. Supp.2d 1310, 1317 (N.D. Okla. 2000) (all applying same standard in medical device cases).

The identical standard has been applied in Oklahoma cases involving prescription drugs.  E.g., Eck v. Parke, Davis & Co., 256 F.3d 1013, 1017-18 (10th Cir. 2001) (applying Oklahoma law); Agee v. Purdue Pharmaceuticals, Inc., 2004 WL 5352989, at *4 & n.12 (W.D. Okla. Nov. 22, 2004), aff’d, 242 F. Appx. 512 (10th Cir. 2007).

Oregon

We concluded that Oregon was a “case-by-case” jurisdiction in 2011.  Two of the three relevant cases involved prescription medical devices – specifically IUDs.  Coursen v. A.H. Robins, 764 F.2d 1329, 1337 (9th Cir. 1985); Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1148-49 (D. Or. 1989).  The same standard applies to vaccines. Senn v. Merrell-Dow Pharmaceuticals, Inc., 751 P.2d 215, 218 n.4 (Or. 1988).  Once again there is no reason to believe that different standards apply to different types of prescription medical products.

Pennsylvania

As discussed in Hahn v. Richter, 673 A.2d 888, 889-91 (Pa. 1996), Pennsylvania has always applied comment k “across the board” in prescription drug cases.  See our 2011 discussion for more details on other Pennsylvania appellate authority doing so.  By the way, the then “pending” Pennsylvania Supreme Court appeal continued this application.  Lance v. Wyeth, 85 A.3d 434, 442 n.11 (Pa. 2014) (some jurisdictions “including Pennsylvania, have taken a blanket approach applying comment k to preclude strict-liability design-defect claims for all prescription drugs”).

While the Pennsylvania Supreme Court has never decided a comment k case involving a medical device, the intermediate appellate court did in Creazzo v. Medtronic, Inc., 903 A.2d 24 (Pa. Super. 2006):

[Plaintiffs] challenge the trial court’s determination that their strict liability claim is barred by Restatement 2d of Torts section 402A, comment k.  Comment k excludes certain products from the definition of “unreasonably dangerous” used in section 402A on the basis that they are incapable of being made safe for their intended use, but are useful nonetheless. . . .  [comment k quotation omitted]

In this case, the trial court applied this section to the [medical device], citing our Supreme Court’s decision in Hahn v. Richter [citation omitted], in which the high court adopted comment k. . . .  In applying comment k here, the trial court reasoned that given the potential utility of the [device], no significant distinction can be drawn between the device and the drug upon which the Supreme Court based its decision in Hahn.  The court concluded accordingly that strict liability could not be a basis for liability in this case. [Plaintiffs] contend that . . . comment k does not apply to medical devices because the comment text does not mention them.  They cite no authority, however, for so restrictive an interpretation either of comment k or of Hahn, nor do they provide significant analysis of the language they seek to apply. We find no reason why the same rational applicable to prescription drugs may not be applied to medical devices.

Creazzo, 903 A.2d at 30-31 (citations omitted) (emphasis added).

Plaintiffs have tried and tried to avoid application of Pennsylvania’s “across-the-board” rule to medical devices, to no avail − the only area of significant disagreement concerns manufacturing, not design, defect claims.  See Lawrence v. Synthes Inc., 2002 WL 32747667, at *24 n.101 (Pa. C.P. July 25, 2002) (“[p]rescription medical devices must be analyzed similarly” to Hahn), aff’d mem., 860 A.2d 1142 (Pa. Super. 2004) (table); Ideluca v. C.R. Bard, Inc., 2018 WL 807158, at *3 (W.D. Pa. Feb. 9, 2018) (strict liability warning and design claims properly dismissed); Smith v. Howmedica Osteonics Corp., 251 F. Supp.3d 844, 848 (E.D. Pa. 2017) (“[w]here Comment k applies, its plain language bars strict liability claims that assert a design defect”); Wagner v. Kimberly-Clark Corp., 225 F. Supp.3d 311, 316 (E.D. Pa. 2016) (“Pennsylvania law prohibits strict liability claims based on a ‘design’ defect or a ‘failure to warn’ . . . against medical device and drug manufacturers”); Carson v. Atrium Medical Corp., 191 F. Supp.3d 473, 477 (W.D. Pa. 2016) (“the Court will apply Comment k, without exceptions, to medical devices”); McLaughlin v. Bayer Corp., 172 F. Supp.3d 804, 833 (E.D. Pa. 2016) (“Comment k’s prohibition of strict liability-design defect and strict liability-failure to warn claims for prescription drugs should also apply to medical devices”); Wilson v. Synthes United States Products, LLC, 116 F. Supp.3d 463, 465 (E.D. Pa. 2015) (comment k “has been consistently applied by Pennsylvania state and federal courts to medical device cases, leading to a finding that plaintiffs may not assert strict liability claims against medical device manufacturers”); Runner v. C.R. Bard, Inc., 108 F. Supp.3d 261, 266 (E.D. Pa. 2015) (following “the settled doctrine among our colleagues that comment k bars the imposition of strict liability against medical device manufacturers”); Cutruzzula v. Bayer Healthcare Pharmaceuticals, 2015 WL 8488670, at *3 (Mag. W.D. Pa. Nov. 17, 2015) (in face of defendant’s motion, “removing Plaintiff’s strict liability claims in light of Lance and Hahn”), adopted, 2015 WL 8492767 (W.D. Pa. Dec. 10, 2015); Kramme v. Zimmer, Inc., 2015 WL 4509021, at *4-5 (M.D. Pa. July 24, 2015) (“we predict that the Pennsylvania Supreme Court would apply comment k to prescription medical devices, as it is applied to prescription drugs”; Tincher did not change the existing jurisprudence concerning strict liability with respect to prescription drugs and medical devices”); Cogswell v. Wright Medical Technology, 2015 WL 4393385, at *3 (W.D. Pa. July 16, 2015) (“Plaintiff’s argument that exceptions be made is unpersuasive, and the Court will apply Comment k to medical devices”); Terrell v. Davol, Inc., 2014 WL 3746532, at *5 (E.D. Pa. July 30, 2014) (“in the case of prescription drugs and devices, strict liability claims based on all three defective conditions, including manufacturing defects, are barred in Pennsylvania”) (footnote omitted); Stout v. Advanced Bionics, LLC, 2013 WL 12133966, at *8 (W.D. Pa. Sept. 19, 2013) (“claims based upon strict product liability are barred by comment k”); Shelley v. Ethicon, Inc., 2013 WL 3463505, at *2 (E.D. Pa. July 10, 2013) (“Hahn has been broadly applied to both prescription drugs as well as prescription medical devices.”); Kline v. Zimmer Holdings, Inc., 2013 WL 3279797, at *6 (W.D. Pa. June 27, 2013) (“the motion to dismiss should be granted with respect to Plaintiffs’ strict liability design defect and failure to warn claims”); McPhee v. DePuy Orthopedics, Inc., 989 F. Supp.2d 451, 461 (W.D. Pa. 2012) (“agree[ing] with the prediction of our sister courts in this Circuit that the Supreme Court of Pennsylvania would extend this holding to medical device manufacturers”); Kee v. Zimmer, Inc., 871 F. Supp.2d 405, 409 (E.D. Pa. 2012) (“as a matter of Pennsylvania law, there is no strict liability for harm caused by medical devices”); Gross v. Stryker Corp., 858 F. Supp.2d 466, 481 (W.D. Pa. 2012) (courts “have continued to apply comment k to medical devices”); Killen v. Stryker Spine, 2012 WL 4498865, at *3-4 (E.D. Pa. Sept. 28, 2012) (comment k precludes strict liability design and warning claims in medical device cases); Doughtery v. C.R. Bard, 2012 WL 2940727, at *3 (E.D. Pa. July 18, 2012) (following “numerous courts in this district [that] have predicted that the Supreme Court would extend comment k to prescription medical devices”; Horsmon v. Zimmer Holdings, Inc., 2011 WL 5509420, at *2 (W.D. Pa. Nov. 10, 2011) (“[w]hile other jurisdictions might recognize caveats to Comment k’s exclusion of strict liability claims, this Court must apply Pennsylvania law, which does not recognize such caveats”); Esposito v. I-Flow Corp., 2011 WL 5041374, at *4 (E.D. Pa. Oct. 24, 2011) (“[p]rescription drugs and medical devices . . . are unavoidably dangerous products”); Riley v. Medtronic, Inc., 2011 WL 3444190, at *10 (W.D. Pa. Aug. 8, 2011) (“comment k applies to medical devices”); Geesey v. Stryker Corp., 2010 WL 3069630, at *5 (E.D. Pa. Aug. 4, 2010) (“comment k applies to medical devices”); Kester v. Zimmer Holdings, 2010 WL 2696467, at *9 (W.D. Pa. June 16, 2010) (Hahn “‘unambiguously’ denies the application of strict liability”); Halsel v. Zimmer, Inc., 2009 WL 10689768, at *3 (W.D. Pa. March 25, 2009) (“the Pennsylvania Supreme Court likely would find that comment k to §402A is applicable to prescription medical devices and would bar strict liability claims”); Giacalone v. Lacrimedics, Inc., 2008 WL 11365183, at *5 n.6 (E.D. Pa. Nov. 24, 2008) (noting the “many” Pennsylvania decisions applying comment k to medical devices); Soufflas v. Zimmer, Inc., 474 F. Supp.2d 737, 750 (E.D. Pa. 2007) (“predicting, based on its reasoning in Hahn, that Pennsylvania Supreme Court would extend §402A’s comment k to exclude prescription medical devices from strict liability”); Parkinson v. Guidant Corp., 315 F. Supp.2d 741, 747 (W.D. Pa. 2004) (“the same considerations exempting prescription drugs from the ambit of §402A equally apply to prescription medical devices”); Davenport v. Medtronic, Inc., 302 F. Supp.2d 419, 442 (E.D. Pa. 2004) (“Comment k precludes application of Section 402A to prescription medical devices”); Murray v. Synthes U.S.A., Inc., 1999 WL 672937, at *7 (E.D. Pa. Aug. 23, 1999) (“the same reasoning underlying Comment k that excludes prescription drugs from Section 402A should also apply to prescription medical devices”); Burton v. Danek Medical, Inc., 1999 WL 118020, at *7 (E.D. Pa. March 1, 1999) (“the same reasoning underlying Comment k that excludes prescription drugs from Section 402A should also apply to prescription medical devices”); Taylor v. Danek Medical, Inc., 1998 WL 962062, at *7 (E.D. Pa. Dec. 29, 1998) (“predict[ing] that the Pennsylvania Supreme Court will determine, pursuant to its reasoning in Hahn, that prescription medical devices are likewise not covered by” strict liability).

Courts in other states, likewise interpreting Pennsylvania law, have also applied comment k across the board to medical devices:

Lance’s recognition that negligent design claims are available in a pharmaceutical products liability case does nothing to upset [general] rule precluding strict liability claims against pharmaceutical drug manufacturers. . . .  Pennsylvania uses a “blanket approach applying comment k to preclude strict-liability design-defect claims for all prescription drugs.”  Lance, 85 A.3d at 442 n.11.  This court concludes that Plaintiff . . . may bring negligence claims predicated on failure to warn, design defect, or other negligence-based theories, but she cannot bring strict liability claims. . . .

Plaintiffs other arguments fare no better. . . .  [C]ertain generic prescription drugs are allowed to be sold even though they do not go through the FDA’s pre-market approval process, and these drugs retain their exemption from strict liability. . . .  Simply put, Plaintiff’s arguments about the level of regulatory scrutiny brought to bear on drugs and medical devices do not satisfy the court that they fare differently under comment k of the Second Restatement.

In re Zimmer NexGen Knee Implant Products Liability Litigation, 2015 WL 3669933, at *35-36 (N.D. Ill. June 12, 2015) (applying Pennsylvania law) (citations omitted).  Accord Delaney v. Stryker Orthopaedics, 2009 WL 564243, at *6 (D.N.J. March 5, 2009) (“Comment k of Section 402A denies application of strict liability to products considered ‘unavoidably unsafe’”; “[t]his prohibition has been extended to medical devices”) (applying Pennsylvania law).

Finally, in the one pre-Hahn case to consider a medical device, Ford v. McGhan Medical Corp., 142 Pitts. Leg. J. 201 (Pa. C.P. Allegheny Co. 1994), the court decided, again that prescription drugs and medical devices were treated the same, but applied a “case-by-case” approach.  Ford no longer accurately states Pennsylvania law, but does illustrate the principle at issue here – that whatever substantive approach that courts take towards comment k, that approach should apply to all types of prescription medical products.

Puerto Rico

Our 2011 comment, “[t]here’s no comment k law that we know of in Puerto Rico,” remains accurate today.

Rhode Island

We classified Rhode Island as “case-by-case” in 2011.  We have found no Rhode Island cases discussing comment k, one way or the other, as to any prescription medical product other than a prescription drug.

South Carolina

Based solely on Brooks v. Medtronic, Inc., 750 F.2d 1227 (4th Cir. 1984) (applying South Carolina law), a medical device case, we concluded in 2011 that South Carolina treated comment k in an “across-the-board” fashion. Id. at 1230-31 (prescription medical products ““are deemed ‘unavoidably unsafe,’ but are not defective or unreasonably dangerous if they are marketed with proper directions for use or include adequate warnings of potential side effects”).

So the reverse of the common situation has been true in South Carolina – medical device precedent has been applied in prescription drug cases.  See Carnes v. Eli Lilly & Co., 2013 WL 6622915, at *3-4 (D.S.C. Dec. 16, 2013) (applying Brooks to prescription drug case; rejecting plaintiff’s attempt to distinguish between drugs and devices).

South Dakota

In another N = 1, situation, in 2011, we concluded that the only available South Dakota comment k precedent applied it in an “across-the-board” fashion.

The number of relevant comment k cases still equals one in South Dakota.

Tennessee

The only comment k language out of Tennessee in 2011 sounded like “across-the-board” to us.  See also Laws v. Johnson, 799 S.W.2d 249, 252 (Tenn. App. 1990) (holding, without individualized analysis that comment k “governs the case at bar” involving prescription drug).

Since then, in Rodriguez v. Stryker Co., 680 F.3d 568 (6th Cir. 2012) (applying Tennessee law), the court agreed with the application of comment k to medical devices:

In rejecting [plaintiff’s] strict liability claim, the district court invoked comment k . . ., which insulates from liability manufacturers of unavoidably unsafe products that are properly prepared and accompanied by an adequate warning.  [Plaintiff] does not argue that the district court erred in applying comment k to his claim. . . .  Because plaintiff’s] duty-to-warn arguments fail, this argument necessarily fails as well.

Id. at 575. See Isbell v. Medtronic, Inc., 97 F. Supp. 2d 849, 861 (W.D. Tenn. 1998) (labeling  medical devices as “unavoidably unsafe products” based on prescription drug precedent); Harwell v. American Medical Systems, Inc., 803 F. Supp. 1287, 1300 (M.D. Tenn. 1992) (applying comment k to medical device without individualized application, beyond citing to another case similarly holding).

Texas

And now for one of the states that prompted this post.  As we stated in 2011:

Texas is a comment k/unavoidably unsafe product across-the-board state.  Centocor, Inc. v. Hamilton, 310 S.W.3d 476, 516 (Tex. App. 2010) (comment k “provide[s] a defense to a design defect claim”), app. pending; Schwarz v. Block Drug Co., 180 F.3d 261, 1999 WL 274409, at *1 (5th Cir. 1999) (“Under comment K of the Restatement of Torts (Second) § 402A, a drug manufacturer is responsible in damages only if it failed to warn of a defect of which it knew or should have known.”) (unpublished); Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1273-74 (5th Cir. 1974) (applying unavoidably unsafe standard without individualized assessment); Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007) (“[p]rescription drugs are not susceptible to a design defect claim where, as here, the drug is “accompanied by proper directions and warning”); Carter v. Tap Pharmaceuticals, Inc., 2004 WL 2550593, at *2 (W.D. Tex. Nov. 2, 2004) (“[u]nder Texas law, all FDA-approved prescription drugs are unavoidably unsafe as a matter of law”); Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 595 (W.D. Tex. 2002) (“[t]he Court thus holds that under Texas law and comment k of the Restatement, Defendants can only be held strictly liable if the drug was not properly prepared or marketed or accompanied by proper warnings”); cf. Brockert v. Wyeth Pharmaceuticals, Inc., 287 S.W.3d 760, 770-71 (Tex. App. 2009) (affirming summary judgment against design defect claim involving prescription drug on ground of lack of alternative design); Gerber v. Hoffmann-La Roche Inc., 392 F. Supp.2d 907, 922 (S.D. Tex. 2005) (same).

To these we would include the additional citations that we found when we researched our prior post discussing the legal rulings in Pinnacle Hip:

Pinnacle Hip complained, in a footnote, that “Texas caselaw offers almost no guidance on how to go about that case-by-case inquiry.”  Id. at [772] n.22.  There is good reason for that lack of precedent – because Texas law has not employed tests that require such inquiry.  See . . . Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 930 F. Supp.2d 808, 817-18 (S.D. Tex. 2013) (applying comment k to prescription drug without case-by-case analysis); Woodhouse v. Sanofi-Aventis United States LLC, 2011 WL 3666595, at *3-4 (W.D. Tex. June 23, 2011) (holding, without further analysis, that “comment k applies to products such as [defendant’s prescription drug]”). . . .

Omitting substantially identical citations to Reyes, Holland, Carter, and Hackett.

Since 2011, the most noticeable development was the Texas Supreme Court’s reversal in Hamilton and its resounding adoption of the learned intermediary rule, which we celebrated here.  The discussion of the unavoidably unsafe doctrine in Hamilton certainly sounds “across-the-board,” since it does not draw any product-specific distinctions, and equates unavoidably unsafe with availability only by a physician’s prescription:

[A]s the official comment to the Restatement (Second) of Torts notes, the learned intermediary doctrine applies particularly to the medical field and unavoidably unsafe products like prescription drugs, which, by law, cannot go from the manufacturer to the end user except through a prescribing physician.  In other products-liability contexts, such as the sophisticated user or bulk supplier scenarios, however, the doctrine could apply to any type of product, not just those that are unavoidably unsafe, and the applicability of the learned intermediary doctrine in those contexts turns on whether the manufacturer’s or supplier’s reliance on the intermediary to warn the end user is reasonable.

Id. at 165 (comment k citation omitted) (emphasis added).

Further, with respect to the Fifth Circuit’s supposed distinction between prescription drugs and medical devices, Hamilton cited and relied on medical device (and vaccine) cases, in addition to prescription drug decisions, interchangeably throughout its discussion of learned intermediary principles.  Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 155 n.16, 159-60, 170 (Tex. 2012).  If Hamilton had thought there was some fundamental divide between types of prescription medical products, as Pinnacle Hip supposed, 888 F.3d at 772, surely the Texas Supreme Court would have included something, anything – not even a footnote – containing a caveat leaving open that possibility.  Nothing.  Instead, where Hamilton mentioned medical devices, it treated them as equivalent to prescription drugs.

  • 372 S.W.3d at 155 n.16 (including “medical device” case in string citation of Texas cases following learned intermediary rule).
  • Id. at 157 (applying Restatement §6, which as discussed above, treats drugs and devices identically).
  • Id. at 158 n.17 (including at least five medical device decisions among the “prescription drug” cases adopting rule).
  • Id. at 159 (more reliance on Restatement §6).
  • Id. at 166 (discussing as one “informational materials provided by healthcare providers, pharmaceutical and medical-device manufacturers”).

Also, since 2011, “Texas courts have applied Comment k to exempt prescription drugs from strict liability under a design defect theory.”  Anastasi v. Wright Medical Technology, Inc., 16 F. Supp.3d 1032, 1041 (E.D. Mo. 2014) (“Texas courts have applied Comment k to exempt prescription drugs from strict liability under a design defect theory”).  See Robles v. C.R. Bard, Inc., 2015 WL 11120857, at *3 (N.D. Tex. March 23, 2015 (“agree[ing] with Defendants that comment k applies to medical devices as well as pharmaceutical drugs”; only surviving claim requires inadequate warnings); Friske v. ALZA Corp., 2011 WL 13233327, at *12 (N.D. Tex. April 29, 2011) (“the Court acknowledges and agrees with the widespread interpretation that comment k provides that prescription drugs in general are unavoidably dangerous as a matter of law”; refusing to distinguish between drug and medical device attributes of drug-eluting skin patch).

So, that’s the Texas law that we have.  What law did Pinnacle Hip offer to support a different interpretation?

Zilch.  Not even a “lone federal district court decision,” 888 F.3d at 772 n.19 – which as just discussed is hardly “lone” at all.  Pinnacle Hip cites not one Texas law decision either:  (1) applying comment k on a “case by case” basis; or (2) distinguishing between medical devices and prescription drugs for comment k/unavoidably unsafe product purposes.  888 F.3d at 772.  Yet Pinnacle Hip has the gall to state that the defense position is “based on conjecture.”

Once again, we’re dealing with the improper MDL phenomenon of construing state product liability law far more expansively than any state court has ever done, in order to maximize settlement pressure. Nor is the Pinnacle Hip MDL the only source of such abuse.  See Adams v. Boston Scientific Corp., 177 F. Supp.3d 959, 965 (S.D.W. Va. 2016), and numerous similar decisions from the same MDL. Adams refused to apply comment k “across the board” to medical devices that were “neither FDA-approved nor a prescription drug.” Id. at 965.  No Texas court has ever drawn the first distinction, which appears to be between FDA “approval” and “clearance,” and the distinction is meaningless since design defect claims involving Class III medical devices are preempted.  The second point is simply bogus.  The case cited, Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 682 F. Supp.2d 662, 679 (N.D. Tex. 2010), doesn’t even involve a prescription medical product, but rather OTC medication, so it has no relevance to the reasons that real Texas law has applied comment k to all prescription medical products without distinction.  As again, the only contrary precedent to treating prescription medical products equally under comment k is a consequence of MDL abuse.  Don’t mess with Texas law.

Utah

Utah is another state where MDL abuse is threatening established across-the-board application of comment k by drawing spurious distinctions between different types of prescription medical products.  As discussed in 2011, the Utah Supreme Court emphatically adopted “across-the-board” application of comment k in Grundberg v. Upjohn Co., 813 P.2d 89, 95 (Utah 1991), a prescription drug case.  Utah decisions involving medical devices (drug-eluting patches for the most part) have mostly applied Grundberg, and thus comment k “across-the-board”).  Elkins v. Mylan Laboratories, Inc., 2013 WL 3224599, at *4 (D. Utah June 25, 2013) (“[b]ased on this clear authority [Grundberg], Plaintiff’s design defect strict liability claim must be dismissed”); Stanley v. Mylan Inc., 2010 WL 3718589, at *5 (D. Utah Sept. 17, 2010) (“allow[ing] the case to proceed on the understanding that Plaintiffs will not press for a strict-liability design-defect claim”); Lake-Alien v. Johnson & Johnson, L.P., 2009 WL 2252198, at *3 (D. Utah July 27, 2009) (rejecting distinctions between product type; “In the case of prescription pharmaceutical patches, it is nonsensical to separate the liability of the overall product and the substance that it releases.”); Grange v. Mylan Laboratories, Inc., 2008 WL 4813311 (D. Utah Oct. 31, 2008) (“Plaintiffs’ strict liability claim is dismissed to the extent that it is based on an alleged design defect”).  But see Creech v. Stryker Corp., 2012 WL 33360, at *5 n.6 (D. Utah Jan. 6, 2011) (refusing to apply Grundberg to medical devices).

The footnote in Creech was itself critiqued by a footnote in In re Wright Medical Technology, Inc. Conserve Hip Implant Products Liability Litigation, 178 F. Supp. 3d 1321 (N.D. Ga. 2016):

The Creech court’s interpretation of Grundberg overreaches. . . .  The Creech court’s footnote regarding Comment k is inconsistent with the Utah Supreme Court’s holding in Grundberg and, to the extent it concludes that, in Utah, Comment k has been found not to apply to medical devices, the Creech decision misinterprets Grundberg.

In its August 31, 2015, Order, the Court reached a conclusion consistent with the Utah Supreme Court’s decision in Grundberg, and further noted that most courts that had considered the issue have concluded that Comment k applies to medical devices. . . .  The Court concludes again that Utah state courts, when presented with the issue, will conclude that Comment k applies to prescribed medical devices.

Id. at 1350 n.17.  However, that earlier ruling, incorrectly utilized a sub rosa “case-by-case” approach to comment k.  See In re Wright Medical Technology, Inc. Conserve Hip Implant Products Liability Litigation, 127 F. Supp.3d 1306, 1357 (N.D. Ga. 2015) (“[f]or Comment K to apply, a device design ‘must be as safe as the best available testing and research permits’”) (quoting Tansy v. Dacomed Corp., 890 P.2d 881, 885 (Okla. 1994)).  As stated above, however, Oklahoma, unlike Utah, is a “case by case” state.

On appeal, in a decision we didn’t like for a variety of other reasons, the Eleventh Circuit agreed in Christiansen v. Wright Medical Technology, Inc., 851 F.3d 1203 (11th Cir. 2017) (applying Utah law), quoted extensively from Grundberg , found it error to apply what amounted to a case-by-case approach to comment k in a medical device case, but held that the error was “harmless” because the defendant had failed to establish that its device had in fact undergone FDA scrutiny. Id. at 1217 (“the record is silent as to whether that device had obtained FDA approval”).  As you might expect this whole episode also involves an MDL, and incredible pressure to affirm to avoid overturning a great deal of MDL time and effort – but at least the Eleventh Circuit called out the “error” for what it was.  Cf. Cook v. Boston Scientific Corp., 2015 WL 5842744, at *3-4 (S.D.W. Va. Oct. 6. 2015) (avoiding Grundberg by distinguishing between PMA and 510(k) devices that no Utah court has ever drawn).  The pattern of MDL abuse through novel, expansive construction of comment k is quite clear.

In any event, as we discussed recently, the issue of comment k, unavoidably unsafe products and medical devices under Utah law, has now been certified to the Utah Supreme Court, which has the opportunity to sort things out. See Burningham v. Wright Medical Group, Inc., 2018 WL 922362 (D. Utah Feb. 15, 2018).

Vermont

In 2011, we wrote, “There’s nothing about comment k in Vermont.”  There still isn’t.

Virginia

Likewise, what we said about Virginia in 2011 still stands:

Virginia’s never adopted any part of Restatement (Second) of Torts §402A (1965), and rejects strict liability altogether, so it’s also not adopted comment k.  Abbot v. American Cyanamid Co., 844 F.2d 1108, 1115 (4th Cir. 1988).

Virgin Islands

Three in a row.  In 2011, and now, “There’s no comment k law in the Virgin Islands that we know of.”

Washington

We discussed in 2011 how, for a long time, Washington had been an “across the board” comment k state in cases involving both prescription drugs and medical devices.  See Young v. Key Pharmaceuticals, Inc., 922 P.2d 59, 63 (Wash. 1996) (under comment k, a prescription drug manufacturer is liable “only if it failed to warn of a defect of which it either knew or should have known . . . it is liable in negligence and not in strict liability”) (prescription drug case); Terhune v. A.H. Robbins Co., 577 P.2d 975, 977-78 (Wash. 1978) (“the duty of the manufacturer to warn of dangers involved in use of a product is satisfied if he gives adequate warning to the physician who prescribes it”) (pre-Medical Device Amendments device case); Transue v. Aesthetech Corp., 341 F.3d 911, 916 (9th Cir. 2003) (“comment k provides a blanket exemption from strict liability for design defect claims on all prescription medical products”) (medical device case); Adams v. Synthes Spine Co., 298 F.3d 1114, 1117 (9th Cir. 2002) (“Washington applies this [comment k] rule not only to such medical products as vaccines for deadly diseases, but . . . much more broadly, to medical products where the physician acts as a learned intermediary”) (medical device case); Payne v. Paugh, 360 P.3d 39, 50, 53 (Wash. App. 2015) (“comment k establishes an exception to strict liability for unavoidably unsafe products’ such as prescription drugs and medical devices”; “for a design defect claim against a medical device manufacturer of an unavoidably unsafe product under comment k, . . . the standard is negligence”); Kaspers v. Howmedica Osteonics Corp., 2015 WL 12085853, at *8 (W.D. Wash. Oct. 23, 2015) (comment k precludes strict liability as “to [plaintiff’s] two remaining strict liability claims − design defect and failure to warn”). See also Rogers v. Miles Laboratories, Inc., 802 P.2d 1346, 1350-51 (Wash. 1991) (applying comment k to biological).

Most recently, in Taylor v. Intuitive Surgical, Inc., 389 P.3d 517 (Wash. 2017), the court “h[e]ld that the comment k exception is not available to a manufacturer who fails to adequately warn.”  Id. at 528.  That starts to sound more like “case-by-case,” but it’s too soon to tell.  While the product in Taylor was a medical device, the court’s rationale for limiting comment k was not peculiar to medical devices, so we still think that however comment k is going to be applied in Washington, it will applied the same to all prescription medical products.

West Virginia

As of 2011, we found two federal district court cases in West Virginia predicting adoption of a “case-by-case” approach to comment k’s unavoidably unsafe product principle. Both involved vaccines.

Since then, another West Virginia federal district court launched a diatribe against comment k in a medical device case, calling it a “useless relic” and “redundant”:

[W]hat is a defective product must be analyzed in traditional tort terminology.  Through subsequent interpretations . . ., West Virginia has effectively rid itself of the need for the useless relic that is comment k.  Accordingly, there is no reason to apply comment k separately in this case, as its principles have become a part of West Virginia law.  I find additional support in the fact that West Virginia courts have never discussed or applied comment k.

Mullins v. Ethicon, Inc., 117 F. Supp. 3d 810, 820 (S.D.W. Va. 2015) (citations, quotation marks and footnote omitted).  As for the two contrary decisions, “[b]oth cases dealt with vaccines . . . where the quintessential example used by comment k was at issue.”  Id.  Mullins is, we believe, unique in this respect, being the only court in the nation to employ a categorical separation of vaccines from all other prescription medical products.  But that singular distinction was secondary to its main holding, which is that “the West Virginia Supreme Court of Appeals has not and would not adopt comment k” in any situation, id.,which would make West Virginia the fourth state to disregard comment k altogether (not counting those states that reject strict liability).

Whatever West Virginia does, there is little support for treating prescription drugs separately from prescription medical products.

Wisconsin

As we observed in 2011, Wisconsin is another of the few states that does not follow comment k at all.  Collins v. Eli Lilly & Co., 342 N.W.2d 37, 52 (Wis. 1984).  Subsequent tort reform required a risk/utility approach to design defects, but did not include a unavoidably unsafe product exception. See Wis. Stat. §895.047(1)(a).

Wyoming

We concluded in 2011 that Wyoming did not require individual adjudication of whether products were unavoidably unsafe under comment k.  See Thom v. Bristol-Myers Squibb Co., 353 F.3d 848, 852 (10th Cir. 2003) (“Comment k to § 402A establishes that this rule [strict liability] does not apply to ‘unavoidably unsafe products’”) (prescription drug case); Tobin v. Smithkline Beecham Pharmaceuticals, 164 F. Supp.2d 1278, 1288 (D. Wyo. 2001) (“’unavoidably unsafe’ products simply refers to that area of the law regarding those products, such as pharmaceutical drugs, which despite the manufacturers best efforts and intentions contain an unavoidable risk”).  All of this sounds “across the board.”  Nothing in any of these decisions suggests that prescription drugs and medical devices would be subject to different standards.

Sure, it was enjoyable to read In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Product Liability Litigation, ___ F.3d ___, 2018 WL 1954759 (5th Cir. April 25, 2018) (“Pinnacle Hip”), to see plaintiffs’ counsel hoisted on their own petard of improper and prejudicial evidence and arguments.  But there’s more to Pinnacle Hip than “Lanier-on-a-spit,” as it has been described in these parts.  Indeed, blogging plaintiffs’ attorney Max Kennerly, dropped a comment to our first Pinnacle Hip post (which we published – we scrub only spam, not opposing views) asserting that “the rest of the opinion was a huge win for plaintiffs.”

We largely disagree with Max’s comment, and this post explains why.

Initially, we note that the defendant in Pinnacle Hip was swimming decidedly upstream in all of its legal arguments, since it was opposing a jury verdict entered against it and seeking entry of judgment as a matter of law in its favor.  2018 WL 1954759, at *2.  That means all the trial evidence is construed in the plaintiffs’ favor.  Id. at *3 (“JMOL is warranted only if a reasonable jury would not have a legally sufficient evidentiary basis to find for the nonmovant.”) (citations and quotation marks omitted).

Design Claims

The first claim addressed in Pinnacle Hip was design defect.  See 2018 WL 1954759, at *3-9.  The defendant raised several arguments, all unsuccessfully.  First, the defendant argued that plaintiff had failed to satisfy the Texas alternative design requirement because that alternative that the plaintiffs offered – a “metal on plastic” (“MoP”) hip implant – was really a “different product” from the defendants’ metal-on-metal design (“MoM”), and thus cannot serve as a design alternative.  This is an argument we have featured several times on the blog.  In Pinnacle Hip, the conclusion was that “based on the record, that MoP is a viable alternative design to MoM.”  Id. at *4.

While we would have liked to win this, on the facts, this distinction between alternative product and design is more difficult for the defense than in the cases we’ve discussed in our prior posts, which usually involve not using the product at all, or using some other product that is much less suited for the use in question.  Our classic example of alternative cause abuse is Theriot v. Danek Medical, Inc., 168 F.3d 253 (5th Cir. 1999), a Bone Screw case in which the supposed “alternative” was a different type of surgery not using the product at all.  That’s distinct from redesigning one part of a device system to use a different material, as indeed, Pinnacle Hip pointed out.  2018 WL 1954759, at *9.  Pinnacle Hip reaffirmed that similar-use products that “fail[] to perform the discrete kinds of functions for which the alleged defective was designed” or with a “wide disparity in price” cannot be considered alternative designs.  Id. at *4, *7.  However , the risk/utility defect test “contemplates that a proposed alternative design might reduce a product’s utility . . . without rendering the alternative an entirely different product.”  Id. at *5.  That means some variation has to exist without “moot[ing] the entire defect test.”  Id.

Construing the record to favor plaintiffs, Pinnacle Hip resulted in another point on the uncertain, “practically impossible to settle in the abstract,” id., at *4, line between different design and different product.  While we’d like to have won, Pinnacle Hip does not move the line itself in any lasting fashion prejudicial to the defense.  The ultimate holding was that a “cross-linked” MoP is not sufficiently different from the defendant’s MoP design to be considered a different product.  2018 WL 1954759, at *6 & n.13.  The underlying principle that the distinction between product and design seeks to protect is preventing automatic liability against whole classes of products – cigarettes, motorcycles, birth control pills, or pedicle screw fixation devices – for simply being what they are and having certain inherent risks.  That principle remains intact after Pinnacle Hip.

The defendants also lost a preemption argument – that design defect claims “’stand[] as an obstacle to the accomplishment and execution of the full purposes and objectives’ reflected in the MoM-related regulations of the FDA.”  2018 WL 1954759, at *7.  According to the defendants, because the plaintiffs were seeking “categorical” liability, that all MoMs should be “banned outright,” there should be preemption. Id. at *8.  But that’s not what the Fifth Circuit found was what happened:

[I]t is not the case that plaintiffs’ theory reached all possible MoMs.  All would agree that, despite the sweeping language with which plaintiffs presented their case, their claims were impliedly limited to presently available technologies and the adverse health effects they allegedly engender.

Id.  But the record showed that “[t]he FDA effectively withdrew all MoMs from the market . . . and left open a single door in the form of PMA.”  Id.  On this set of facts, it could not be said that banning something that the FDA had already essentially removed from the market, save for an alternative that has not yet produced an FDA-approved product, was an interference with “the FDA’s regulatory objectives.”  Id.

While losing a preemption argument is not something we would recommend, this particular type of preemption argument has never been successful that we are aware of, so it’s no great loss.  We’ve advocated at some length that the Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), decision be overturned.  But that argument is predicated on changes to 510(k) clearance created by Congress in 1990.  In Pinnacle Hip, “MoMs were sold before 1976 and have traditionally been treated as pre-amendment class III devices.”  2018 WL 1954759, at *8.  So Pinnacle Hip doesn’t affect even the distinctions that we draw from Lohr.  The preemption argument rejected in Pinnacle Hip would require the complete reversal of Lohr, even on Lohr’s facts, to succeed.

By far the better preemption argument, based on current law, with respect to 510(k) design defect claims, is that they amount to “major changes” that require prior FDA review, and probably an entirely new supplemental submission, before they could be implemented.  That should put design defect claims at odds with the “independence principle” in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), resulting in preemption of all design claims that could make a difference in a product liability action.  That argument, which does not depend on Lohr either way, was not addressed at all in Pinnacle Hip.

Finally, the defendants in Pinnacle Hip also lost on their Restatement (Second) of Torts §402A, comment k (1965), argument, which was that Texas law holds all prescription medical products, including medical devices, to be “unavoidably unsafe” within the meaning of comment k, so that those “unavoidable” risks can only be warned about and not treated as design defects.  Pinnacle Hip was unwilling to expand Texas’ application of comment k from prescription drugs to include prescription medical devices.  2018 WL 1954759, at *9.  That places Pinnacle Hip in a distinct minority position, since literally hundreds of cases, and the Third Restatement, apply limits on design defect claims equally to all types of prescription medical products.  Bexis’ book collects these cases.  Drug & Medical Device Product Liability Deskbook §2.02[2] at pp. 2.02-13 to -16 n.14 (for the proposition that “almost all courts have extended the unavoidably unsafe product exception to medical devices”).  However, as the Fifth Circuit correctly pointed out, not many of those opinions are under Texas law.

The further discussion of case-by-case versus across-the-board comment k application in Texas, 2018 WL 1954759, at *9, is more troubling, as the trend in Texas courts (in drug and vaccine prescription product cases) has favored the “blanket” approach.  Pinnacle Hip complained, in a footnote, that “Texas caselaw offers almost no guidance on how to go about that case-by-case inquiry.”  Id. at *9 n.22.  There is good reason for that lack of precedent – because Texas law has not employed tests that require such inquiry.  See Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1273 (5th Cir. 1974) (applying comment k without case-by-case analysis to a vaccine; holding that the only viable claim was inadequate warning); Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 930 F. Supp.2d 808, 817-18 (S.D. Tex. 2013) (applying comment k to prescription drug without case-by-case analysis); Woodhouse v. Sanofi-Aventis United States LLC, 2011 WL 3666595, at *3-4 (W.D. Tex. June 23, 2011) (holding, without further analysis, that “comment k applies to products such as [defendant’s prescription drug]”); Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007) (“Prescription drugs are not susceptible to a design defect claim where, as here, the drug is ‘accompanied by proper directions and warning.’”) (quoting comment k); Carter v. Tap Pharmaceuticals, Inc., 2004 WL 2550593, at *2 (W.D. Tex. Nov. 2, 2004) (“Under Texas law, all FDA-approved prescription drugs are unavoidably unsafe as a matter of law”); Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 595 (W.D. Tex. 2002) (“under Texas law and comment k of the Restatement, Defendants can only be held strictly liable if the drug was not properly prepared or marketed or accompanied by proper warnings”).  Contra: Adams v. Boston Scientific Corp., 177 F. Supp.3d 959, 965 (S.D.W. Va. 2016) (refusing to apply comment k across-the-board in medical device case) (applying Texas law).  The comment k portion of Pinnacle Hip is where we think that Max is on the firmest ground.  The decision made Texas law worse.  This issue will ultimately be won in Texas appellate courts or perhaps before the Texas legislature, where it would be quite simple to extend the warning related presumption of §82.007 to all medical devices approved or cleared by the FDA.

Warning Claims

As to warning claims (which Texas law calls “marketing defects”), the defendants lost on adequacy as a matter of law.  Pinnacle Hip, 2018 WL 1954759, at *10.  Unfortunately, defendants usually lose on this ground, so it’s big news – and trumpeted on this blog – when a defendant wins a judicial holding that its warning is adequate as a matter of law.  No surprise there.  In Pinnacle Hip, that discussion ended:

Not until after the FDA issued its proposed rule in 2013 did defendants specifically warn about the metallosis, pseudotumors, and tissue necrosis − the sorts of conditions that plaintiffs maintained caused their revision surgery.

Id. at 11.  As defense counsel, we interpret the Fifth Circuit’s observation as an invitation to seek an adequacy as a matter of law ruling as to post-2013 claims (if there are any) in the litigation.

In the causation discussion pertaining to the warning claims, Pinnacle Hip of course followed the learned intermediary rule.  It discussed the role of “objective” evidence of causation:

At the threshold, the parties debate the relevance, under Texas law, of “objective evidence” − that is, evidence “that a different warning would have affected the decision of a reasonable doctor.” . . . Here, plaintiffs proffered objective evidence in [expert] testimony that, if the full risks of MoM were known to physicians, “they would run to [a different product].”

2018 WL 1954759, at *11 (citations omitted).  As we’ve discussed before, “objective” expert testimony about what “reasonable physicians” would have done is usually disallowed in learned intermediary cases.

On this point, however, Fifth Circuit law, has not been as favorable as other courts.  In Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 812 (5th Cir. 1992), the court actually allowed expert testimony on what a “reasonable” physician might have done – but that case was under Mississippi law.  See Ackermann v. Wyeth Pharmaceuticals, Inc., 526 F.3d 203, 212 (5th Cir. 2008) (suggesting that Thomas would not apply to Texas law).  We’ve been aware of the brief Texas Supreme Court passing reference to “objective” evidence in Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 171 (Tex. 2012) (plaintiffs “presented no objective evidence”), but felt no reason to let the other side know it was there.

Now it’s been discovered, however.  The Fifth Circuit allowed such evidence to be admissible, 2018 WL 1954759, at *12 (“objective evidence is at least relevant”), but did not find it decisive in situations where the plaintiff would otherwise have suffered dismissal.  Critically, Pinnacle Hip did not allow unsupported “expert” testimony about what an objectively “reasonable physician” would have done be enough to let plaintiffs survive when they didn’t have prescriber testimony – which would have been the equivalent of allowing a heeding presumption in Texas, something the Fifth Circuit rejected outright in Ackerman, 526 F.3d at 212-13.

Relevance, however, does not imply sufficiency.  In the [learned intermediary] context, causation entails two distinct factual predicates:  first, that the doctor would have read or encountered the adequate warning; and second that the adequate warning would have altered his treatment decision for, or risk-related disclosures to, the patient.  Centocor addressed only the latter, suggesting a jury might be allowed to presume a particular physician would respond “reasonably” to fuller disclosure.  But that presumption must yield to contrary subjective testimony by the treating physician, and Centocor fails to explain how objective evidence would apply to whether that doctor would have read or encountered the warning in the first instance.  When considered for the limited purpose intimated in Centocor, objective evidence would have little bearing on any of [these] plaintiffs’ claims.

Pinnacle Hip, 2018 WL 1954759, at *12 (footnotes omitted) (emphasis original).  Thus, where the plaintiffs had no testimony from their prescribing physicians, those claims continue to fail, and some “expert” claiming otherwise cannot change the result.  Id. (granting JMOL in no-prescriber testimony cases).  Likewise, any “objective” testimony “must yield to contrary subjective testimony by the treating physician.” Id.  So plaintiffs cannot create questions of fact with expert testimony where the prescriber has affirmatively testified that a different warning would not have changed what s/he did.

Only what the Fifth Circuit described as “mixed bag” prescriber testimony (the prescriber said different things in different parts of his testimony) cases got to the jury in Pinnacle Hip, id. at *13, and those have always been harder cases for the defense anyway.  At best, for plaintiffs, paying some expert to opine that a “reasonable” physician would have heeded a warning won’t save any plaintiff who lacked a plausible warning causation case in the first place.  At worst, Pinnacle Hip means more plaintiff-side noise at trial in cases already going to trial on warning causation.  All in all, the defense side is better off after Pinnacle Hip than where it had been in the Fifth Circuit with only the Thomas precedent.  We definitely don’t agree with Max here.

Personal Jurisdiction

In Pinnacle Hip, the manufacturer’s parent corporation was held potentially liable because of the amount of guidance and control permitted by an inference from the facts (based on a “clear error” standard).  2018 WL 1954759, at *15.  Those facts allowed the court to conclude that more than a “passive parent-subsidiary relationship” existed as to this product.  Id. at *16.  To us that’s “big whoop” for two reasons.  First, the “clear error” standard does not apply at the district court level where jurisdictional motions are initially decided.  Second, and more important going forward, the plaintiffs proceeded under a “stream of commerce” theory where the Fifth Circuit had previously “embraced [the] more expansive” (Brennan) side of the 4-4 split in Asahi Metal Industry Co. v. Superior Court, 480 U.S. 102 (1987).  Pinnacle Hip, 2018 WL 1954759, at *15.  As we’ve discussed, that broad “stream of commerce” jurisdictional theory is probably toast after Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017).  Pinnacle Hip did not even cite BMS in its discussion of personal jurisdiction, so we guess that this argument wasn’t raised.  In light of the BMS precedent, the Pinnacle Hip jurisdictional holding should be treated as something of a “one-off” applicable to this MDL, but not to future litigation where BMS will stand front and center.

Miscellaneous Claims

Pinnacle Hip includes the Fifth Circuit’s full-throated reaffirmance of our favorite Erie principle:

[T]hat debate [about what a Texas court might do] is beside the point.  When sitting in diversity, a federal court exceeds the bounds of its legitimacy in fashioning novel causes of action not yet recognized by the state courts.  Here, despite ample warning, the district court exceeded its circumscribed institutional role and expanded Texas law beyond its presently existing boundary.

2018 WL 1954759, at *17 (footnote, citations, and quotation marks omitted) (emphasis added).  The court therefore threw out the spurious invention of an “aiding and abetting” cause of action that had no reasonable predicate in Texas law.  Id.

The court did allow two arguably weird theories against the parent corporation – all product liability theories imposing liability against a non-manufacturing parent under a theory not also cognizable against the manufacturing subsidiary are likely to be weird − to survive.  One of those, so-called “nonmanufacturer seller” was tied to statutory exceptions to immunity for nonmanufacturers.  Id. at*18.  The court held, instead, that the parent was only held liable for old-fashioned design or warning liability, after the record (again, construed in favor of plaintiffs as verdict winners) established one of statutory exceptions from nonmanufacturer immunity.  Id. That’s a little peculiar to non-Texas lawyers, but since Texas has this statute, it must mean something.

The other oddball claim that survived is one of those “last refuge of a scoundrel” theories, negligent undertaking” (a/k/a “Good Samaritan”) liability.

Texas caselaw reveals no precise control threshold a parent must cross before undertaking a duty to its subsidiary’s customers.  Texas courts have made clear that mere possession of “the authority to compel” a subsidiary is not enough − the parent “must actually” exercise that authority in a manner relevant to the undertaking inquiry.

Pinnacle Hip, 2018 WL 1954759, at *19 (footnote omitted).  Based on the stringent standard for interpreting record evidence, the court let this one slide.  Id.  Not good, but not likely to arise very often.

But there’s more afoot than just these three theories. Two years ago, we awarded In re DePuy Orthopaedics, Inc., 2016 WL 6268090 (N.D. Tex. Jan. 5, 2016), our ranking as the number six worst decision of that year, chiefly because of the large number of unprecedented theories under Texas law that this opinion permitted:

(1) extending negligent misrepresentation beyond “business transactions” to product liability, unprecedented in Texas; (2) ignoring multiple US Supreme Court decisions that express and implied preemption operate independently (as discussed here) to dismiss implied preemption with nothing more than a cite to the Medtronic v. Lohr express preemption decision; (3) inventing some sort of state-law tort to second-guess the defendant following one FDA marketing approach (§510k clearance) over another (pre-market approval), unprecedented anywhere; (4) holding that the learned intermediary rule does not apply whenever a defendant “compensates” or “incentivizes” physicians to use its products, absent any Texas state or appellate authority; (5) imposing strict liability on an entity not in the product’s chain of sale, contrary to Texas statute (§82.001(2)); (6) creating a claim for “tortious interference” with the physician-patient relationship, again utterly unprecedented; (7) creating “vicarious” breach of fiduciary duty for engaging doctors to serve as expert witnesses in mass tort litigation also involving their patients, ditto; and (8) construing a consulting agreement with a physician as “commercial bribery” to avoid the Texas cap on punitive damages, jaw-droppingly unprecedented.

While only item (5) was at issue in Pinnacle Hip, the Fifth Circuit’s invocation of Erie conservatism bears ill for all of the other judicial flights of fancy that have been allowed during the course of the Pinnacle Hip litigation.

Constitutionality of Punitive Damages Cap

For completeness, plaintiffs also lost their constitutional challenge to the Texas statute capping punitive damages at twice compensatory damages.  “Plaintiffs’ cross-appeal is meritless, and we dispose of it by footnote.”  Pinnacle Hip, 2018 WL 1954759, at *1 n.4.  That footnote went further, and characterized those constitutional claims as “frivolous.”  Id. at *23 n.72.  No matter what the constitutional challenge, a punitive damages cap “need only survive rational-basis review,” which it did in Pinnacle Hip “by injecting predictability into exemplary damages awards and preempting potentially unconstitutional awards.”  Id. (citations omitted).

Conclusion

When all is said and done, we view Max’s characterization of Pinnacle Hip as a “huge win for plaintiffs” as mostly overblown hyperbole, perhaps worthy of inclusion in the closing arguments that the Fifth Circuit held warranted a new trial.  The Fifth Circuit did some damage to comment k, but all the rest of the legal holdings were trivial, fact-bound, not likely to be useful in future cases, or some combination of those.  The forceful reiteration of conservative principles of Erie predictions of state law leave us hopeful that the Pinnacle Hip MDL will see some Fifth Circuit-mandated clean up – or, if not, perhaps the appellate court’s not-so-veiled Parthian, parting shot may have to be fired in earnest:

[D]efendants, despite their serious critiques of the district judge’s actions in this case and related MDL proceedings, see In re DePuy Orthopaedics, Inc., 870 F.3d 345, 351 (5th Cir. 2017) (finding “grave error”), have not asked us to require these cases to be reassigned to a different judge under “this court’s supervisory power to reassign,” United States v. Stanford, 883 F.3d 500, 516 (5th Cir. 2018).  We express no view on the issue but note that reassignment is both “extraordinary” and “rarely invoked.”  Id. (citation and internal quotation marks omitted).

Pinnacle Hip, 2018 WL 1954759, at *27, n.83.  Obviously, the Fifth Circuit in Pinnacle Hip was uncomfortable with the prospect of overruling the JPMDL’s assignment of this MDL, but this final footnote stands as a clear warning that, if further provoked (such as by continuing consolidated trials, or resort to other prejudicial evidence that the court noted but did not rule on), it will consider doing so.

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

It may be post Mardi Gras season, but we don’t think there is ever a bad time to embrace the motto – “Laissez les bons temps rouler.” Quite literally – “Let the good times roll.” However, don’t try this with your high school French teacher, because after her gasp of horror, she will tell you that the grammatically correct way to get a party started in France is “Prenons du bons temps.” Of course, the Louisiana version is really Cajun French as opposed to France French and with both having so many good things to offer it’s really a matter of preference in a given moment. Like deciding if you’re in the mood for bouillabaisse or crawfish etouffee; a beignet or a croissant; a Hurricane or a Cabernet Franc.

Now that we’ve got you thinking about what’s for dinner, we can narrow our Louisiana focus to just the Louisiana Products Liability Act (“LPLA”) – hoping to whet your legal appetite now. In the case of Pierre v. Medtronic, Inc., 2018 U.S. Dist. LEXIS 67773 (E.D. Lous. April 23, 2018), plaintiff alleged she was injured as a result of defendant’s self-fixating mesh that was used in plaintiff’s abdominal surgery. Plaintiff alleges she suffered an infection and pain following her surgery. Id. at *2. We are jumping to the end of the decision to immediately lop off several of plaintiff’s claims. The court dismissed claims for breach of warranty of fitness for ordinary use, negligence, breach of implied warranty, negligent misrepresentation, and negligent design all on the grounds that they exceed the scope of the LPLA and the LPLA “sets forth the exclusive theories of liability for manufacturers for damage caused by their products.” Id. at *15.

So, what claims does the LPLA allow? Manufacturing defect, design defect, failure to warn, and express warranty. Id. at *5. And on defendant’s motion to dismiss, only half those claims survived. The first claim to survive, unusual for a drug/device case, is for manufacturing defect. That’s because here plaintiff had a specific allegation that the mesh used in her surgery was improperly sterilized which led to her development of an infection. Because plaintiff is challenging a deviation from the standard procedures for this product, she’s stated a claim for a manufacturing defect. But the court was clear that what plaintiff could not do is attack the defendant’s sterilization process generally, only this particular alleged deviation. Id. at *7-8.

Next plaintiff alleged two design defects. First plaintiff alleged that the mesh was defective in that it was made of polyester, a weaker material than used in other mesh products, and that the weaker material required a different method of being secured which ultimately led to causing plaintiff more pain than she would have suffered with a different method of attachment. Id. at *8-9. Since plaintiff alleged a design defect, alleged that that defect was the cause of one of her injuries (pain), and that alternative designs existed, she passed TwIqbal on this claim. Her second design claim, however, did not meet that standard. Plaintiff alleged that the design of the mesh caused her infection by lowering her pH. But missing from this claim is any suggestion of “the existence of a feasible alternative design that would prevent the alleged injury.” Id. at *10.

There was no splitting the baby on plaintiff’s failure to warn claim. It was dismissed in its entirety. As to the alleged failure to warn about infection, plaintiff relies exclusively on a single marketing document. However, plaintiff failed to allege any facts “to plausibly suggest that [plaintiff’s] surgeon relied, or any competent surgeon would rely, on this marketing document when deciding whether to perform surgery.” Id. at *11. A pretty demanding standard when you infer, and we think the court was so implying, that no competent surgeon relies on marketing material to make medical decisions. Moreover, the court pointed out several ways in which the marketing document cites to other documents, most importantly to the “Instructions for Use” of the mesh demonstrating that “Defendants did not rely solely, if at all, on the marketing document to warn users of the risks.” Id. at *12. Not to mention that the risk of infection is a “common surgical complication” most likely already known to plaintiff’s surgeon. Id.

Plaintiff’s second failure to warn claim was based on a failure to warn that the mesh might contract after surgery causing pain. Id. Here plaintiff failed to allege any facts about what warning was provided to plaintiff’s surgeon relying only on a boilerplate statement that defendant didn’t warn. Id. But such an “allegation is too broad to state a claim because it does not identify (1) which aspects of the product warranted a warning and (2) what injuries resulted from the failure to warn.” Id. at *13. Too vague to withstand dismissal.

So too was plaintiff’s breach of express warranty claim. Plaintiff only alleged that defendant warranted the product was safe and fit for its intended use, merchantable, adequately tested, and did not have dangerous side effects. Id. at *14. But a claim that a product is “safe” or “effective” is only a “general opinion” or “general praise,” insufficient to form the basis for an express warranty under the LPLA.

Of the 6 claims brought that were permissible under the LPLA, only 2 survived the motion to dismiss. Not a complete win, but good enough to put in the “good times” category. And if you don’t want to get embroiled in the French debate, we recommend following the lead of Shirley & Lee from 1956 or The Cars from 1978 and just let the good times roll (in English).

This post does not come from the Reed Smith side of the blog.

 

Favorable New Jersey appellate court decisions in product liability cases are almost always worthy of mention here. So we bring you Goodson v. C.R. Bard, 2018 WL 1370652 (N.J. App. Div. Mar. 19, 2018). To be truthful, we’re bringing it back to you. Bexis discussed the trial court’s decision to grant summary judgment to defendants last year.

As we discussed then, this is a case involving mesh used in hernia procedures. The particular mesh product involved in this case is not involved in the pelvic mesh MDL proceedings. And that may be reflected in the strength of the plaintiff’s expert reports, which is to say that they are not strong at all.  While the plaintiff used experts who have been involved in the pelvic mesh MDL, not one of them seemed to give the right opinions.

In particular, even though plaintiff brought a design defect claim, none of his experts gave an opinion that the design of this particular product was actually defective or that such a defect caused the plaintiff’s injuries. Id. at *4-5. Rather, his experts simply described various alleged risks of the product. This is not even close to sufficient to support a design defect claim. Id. Nor did any of the experts opine that there was a safer, feasible alternative design. Id. Similarly, even though plaintiff also brought a negligent failure to wan claim, none of the experts gave an opinion on the standard of care for issuing a warning or whether defendants met that standard. Id. at *5-6. In other words, plaintiff didn’t have a warnings expert to opine on whether the warning was adequate.

In short, plaintiff’s experts struck out looking.

To make matters worse, the treating doctor testified that he was aware of the potential risks of this mesh product and informed plaintiff of them. Id. at *6. There goes proximate causation under the learned intermediary doctrine.

Accordingly the New Jersey appellate division upheld the trial court’s grant of summary judgment to defendants. Unfortunately, it designated its opinion “not for publication.” That’s too bad. But rest assured: it happened. Westlaw already has it on-line. And the trial court’s decision, which Bexis’s post from last year lays out in considerable detail, has an excellent analysis of all the weaknesses in plaintiff’s case, an analysis that was essentially adopted by the Appellate Division. And, of course, we’ve written on it twice now. With all of that, we’re confident that you’ll find some way to make use of this appellate decision in your cases.

Last weekend we returned to Utah, one of the most beautiful states in the USA.  Over the years we had taken in the polite delights of Salt Lake City, the powderpuff snow of Park City, and the cinematic enthusiasms of the Sundance Festival.  This time was different.  It was an occasion to explore Zion National Park, where wind, water, and time have carved splendor out of the rocks.  The apricot-colored natural amphitheaters put on quite a show in February.  Mule deer didn’t mind us at all as they chomped on rough, stubborn grass, mere feet away from us and a frozen waterfall. We drove through a mile-long tunnel with occasional natural ‘windows’ allowing light in from the canyons.  Every sublime inch of the place, every cactus skirted by snow, every stone arch, every smiling hiker, every helpful ranger, supplied further proof that the National Park system truly is America’s best idea.  If Yellowstone, Yosemite, and Grand Canyon do not already clinch the argument, Zion silences the debate with one long shadow cast from the Court of the Patriarch peaks or one gurgling note from the demure but insistent Virgin River.

It was good to get back to Utah.

Today’s post also gets back to Utah.  Three weeks ago we reported on a federal court decision in Burlingame v. Wright Medical Group, Inc., (D. Utah), a product liability personal injury case involving a hip implant.  The defendant filed a motion for summary judgment.  The solitary vexing issue was whether comment k to section 402A of the Restatement (Second) of Torts applies to medical devices so as to shield them strict liability design defect.  Utah law governed, and it is absolutely clear that Utah law applied comment k across the board to prescription drugs. But what about medical devices?  Our take on that question is to wonder why devices and drugs should be any different.  The need for a prescription should be enough to establish the “unavoidably unsafe” element of comment k, so the issue should be clear.

That’s apparently what the defendant in Burlingame thought, too, as it argued that the federal court had all the case law it needed to apply comment k and dismiss the strict liability claim.  The plaintiff  also was content with existing law, but in a different way, as the plaintiff argued that the federal court could conclude that medical devices fell outside of comment k.  Neither party asked the court to certify the question to the Utah Supreme Court, but that is what happened. It not only happened sua sponte, it happened over both sides’ objections.  That is what we reported on three weeks ago.

But it is not the end of the story.   The federal court then invited the parties to try to agree on what issues should go to the Utah Supreme Court.  Well, inasmuch as neither party wanted to add the Utah Supreme Court to the festivities, should anyone really be surprised that the parties could not agree? The federal court certainly seemed surprised, and more than a little disappointed.   In a new opinion, Burlingame v. Wright Medical Group, Inc., 2018 U.S. Dist. LEXIS 25637 (D. Utah Feb. 15, 2018), the federal court blasts the parties for submitting one-sided, self-serving position papers.  Isn’t that a little like Captain Renault in Casablanca declaring how shocked he is that gambling has been going on at Rick’s Cafe?  Anyway, the federal judge grabbed a pen and crafted the following questions for the Utah Supreme Court to enjoy and resolve:

1.  Under Utah law, does the unavoidably unsafe exception to strict liability in design defect recognized in Comment K to section 402(A) of the Restatement (Second) of Torts apply to implanted medical devices?

2.  If the answer to Question 1 is in the affirmative, does the exception apply to all implanted devices, or does the exception apply only to some devices on a case-by-case basis?

3.  If the exception applies on a case-by-case basis, what is the proper analysis to determine whether the exception applies?

4.  If the answer to Question 1 is in the affirmative, does the exception require a showing that such devices were cleared for market approval through the FDA’s premarket approval process as opposed to the 510(k) clearance process?

Dear reader, we hope you do not think it presumptuous if we draft answers on behalf of the Utah Supreme Court:

1.  Yes, comment k applies to medical devices.  The number of courts that have distinguished between drugs and devices with respect to application of comment k is truly miniscule.  And the reasoning is … unimpressive. Why would Utah want to join such a dreadful, dull minority? But the correct adjective is “prescription,” not “implanted.”  Sure, any implanted device will require a prescription, but there are plenty of other medical devices that fit the unavoidably unsafe bill without being implants.  Ever heard of medical lasers?  Why some plaintiffs or courts fixate on implantation is beyond us.  The permanence of the thing shouldn’t matter.  Prescription drugs don’t stay in the system permanently.  If the court wants to stay parallel (not our favorite word in the DDL universe, but stay with us a moment) with drug comment k case law, the issue is whether or not a doctor’s prescription is required.

2.  The comment k exception should apply to all prescription medical devices.  Across the board.  Case-by-case noodling makes no sense, is a burden on the court, provides no guidance to parties and, all-in-all, is the way of nincompoops.

3.  See, by adopting across-the-board, we’ve already aided judicial economy by freeing you from answering this silly question.

4.  The only thing dumber than drawing a line between implant and no-implant would be to draw a line between preapproval and 510(k).  By the way, the court’s question mucks up the distinction between approval and clearance. More to the point, how does regulatory pathway determine the unavoidably unsafe categorization?  There is no logical connection whatsoever. Either pathway concludes in a determination of safety. You do know about the substantial similarity test, right?  The plaintiffs asked for this horrible question, didn’t they?  (To be fair, this is not the first time a court mixed up the 510(k) vs. PMA issue with comment k.  Last year, we grieved over an 11th Circuit decision that engaged in the selfsame heresy.)

Some of these certification questions strike us as being unsafe, but there is nothing remotely unavoidable about them.

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.