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

After more than a month away at trial, we probably should not have picked a case that hit so close to home, so to speak.  Spear v. Atrium Medical Corp., — F. Supp. 3d –, 2022 WL 3357485 (E.D. Pa. Aug. 12, 2022), is a hernia mesh case brought by a frequent flyer lawyer via a cookie-cutter complaint not tailored to the law or facts of the case.  The decision considers a number of recurring issues, including the meaning of a Pennsylvania Supreme Court decision that reversed in part a case we won on summary judgment.  Even for an order on motion to dismiss, Spear was far too generous for the plaintiffs, at least for us.

We start with what should be a recitation of the basic facts of the case, except that the opinion omitted the basic facts.  The court indicated the hernia device at issue, the month when it was implanted, and the month when plaintiffs sued.  Curiously absent were the name of the implanting physician, where the device was implanted, that the device was available only by prescription, what injuries plaintiffs claimed, how he claimed they occurred, what intervention (if any) happened, and a number of other items we would have expected to be presented.  Are we just being curmudgeonly, like we might be if we pointed out that the decision often did not cite Pennsylvania state court decisions correctly?  Not only that.  As we have noted previously, the presentation of facts can foretell the rigor of the analysis to follow.  It did here.

The procedural history was presented.  Plaintiff sued the US manufacturer, its US parent (at the time of the implant), and its parent’s Swedish parent (at the time of the implant).  (The court did not mention that the manufacturer was sold in 2018.)  The US entities filed a motion to dismiss on 12(b)(6) and the Swedish entity filed a motion to dismiss both on lack of personal jurisdiction and on 12(b)(6).  We will take on the personal jurisdiction issue first, as it should have been very simple given the current Supreme Court precedent.  Since Bauman, it has been clear that there is no general personal jurisdiction over foreign entities simply because they have subsidiaries in the US.  Under Walden, specific personal jurisdiction over a non-resident defendant must be based on contacts with the forum created by the defendant that give rise to the claim.  When the Spear court addressed the Swedish indirect parent’s jurisdictional motion, it cited no Supreme Court or recent authority.  Without analysis, it concluded that:  “Plaintiffs have not established a prima facie case of jurisdiction. They have, however, made enough of a showing to warrant discovery on jurisdiction.”  Id. at *5.  The cite for the latter conclusion was “Toys “R” Us, Inc. v. Step Two, S.A., 318 F.3d 446 (3d Cir. 2003) (“[C]ourts are to assist the plaintiff by allowing jurisdictional discovery unless the plaintiff’s claim is ‘clearly frivolous.’ ”).”  We find this strange, not just because of the citation issues, but because Toys “R” Us predated Bauman and Walden by nine years.  As the Bauman court said, “it is hard to see why much in the way of discovery would be needed to determine where a corporation is at home.”  517 U.S. 117, _ n. 20 (2014).  The Swedish company was surely not at home in Pennsylvania for purposes of general jurisdiction.  In terms of specific jurisdiction according to the standards of Walden, one would expect there to be detailed allegations in the complaint relating to the direct actions of the Swedish company giving rise to liability.  In terms of whether there was a non-frivolous basis for a claim to be asserted against the Swedish company in Pennsylvania, one would expect the court to evaluate the allegations in the complaint.  None of that is presented in Spear, so it reads like a rubber stamp for unnecessary jurisdictional discovery based on a case from well before the tightening of the jurisdictional standards.  That is troubling.

The rest of the opinion had similar analytical and temporal issues.  The first up of the six asserted claims was strict liability design defect.  We will not attempt to do a full recap of all the posts and decisions on the issue of whether Pennsylvania recognizes such a claim for prescription medical products. (See here, here, here, and here)  Suffice it to say that it was long considered established law that it did not.  Over the last few years, there have been a number of decisions out of Pennsylvania federal courts addressing the question of whether such a claim can be maintained against the maker of a prescription medical device.  Just as drawing a line on applying the learned intermediary doctrine to some but not all prescription medical products makes no sense, so would drawing such a line on strict liability.  The strong majority of courts to consider this issue have applied the ruling from Hahn v. Richter, 673 A.2d 888 (Pa. 1996), which rejected strict liability in a prescription drug case, to cases over prescription medical devices.  Last year, the Pennsylvania Supreme Court accepted the Third Circuit’s request to consider this issue again, but that case was resolved before a decision. So, the issue remains open, at least to some.

Strangely, the origin of the new “debate” over this issue seems to have been language in the Pennsylvania Supreme Court’s decision in Lance v. Wyeth, 85 A.3d 434 (Pa. 2014), a prescription drug case.  The defendant won Lance at the trial court level because 1) the prescribing physician testified in deposition (taken by some young hotshot) that no change in the warning as to the risk of primary pulmonary hypertension would have changed his decision to prescribe a weight loss medication to plaintiff’s decedent because her extreme obesity presented significant health risks and 2) plaintiff had no strict liability claims under Pennsylvania law.  On appeal, the plaintiff was allowed to carve out a previously unrecognized claim for what is generously called “negligent design” but is more accurately called “negligent failure to withdraw a legally marketed prescription medical product.”  (We will skip the massive preemption issues with such a claim, but feel free to peruse some posts.)  The appellate courts did not reverse the dismissal of the strict liability counts—knocked out of the master complaint on preliminary objections, the Pennsylvania equivalent of 12(b)(6).  Instead, the line remained firm that Pennsylvania allowed negligence claims for prescription medical products—albeit with an unwarranted expansion—and not strict liability claims.

Fast forward to Spear.  The question of strict liability was framed as “whether Pennsylvania law per se excludes medical devices from strict liability.”  2022 WL 3357485, *1.  Clearly, this is the wrong question for a federal district court sitting in diversity.  Better would have been “does Pennsylvania recognize strict liability claims for prescription medical devices and, if this has not been decided, would it?”  After noting that most Eastern District of Pennsylvania cases to decide the issue have rejected strict liability—but without acknowledging the even stronger majority among other courts addressing the issue—the court looked to a footnote in Lance and general language from Tincher v. Omega Flex, Inc., 104 A.3d 328, 396 (Pa. 2014), a case about steel tubing used as a gas line.  Without analysis, the court stated “Given these decisions, there is little to support a prediction that the Pennsylvania Supreme Court would expand comment k to medical devices as a categorical exception from strict liability.”  2022 WL 3357485, *1.  Even setting aside that the case involves a prescription medical device, huh?

The cited language from Lance suggests little to support this facile conclusion:

Wyeth is quick to point out that many other jurisdictions have not implemented a blanket approach to comment k, as it pertains in the strict-liability arena, and, thus, it takes the position that such cases are irrelevant. We do not share Wyeth’s view, however, that blanket application of the commentary for purposes of strict liability and preclusion of negligence-based liability premises necessarily go hand-in-hand. Indeed, it is our perspective that this Court applied a rather one-dimensional analysis in its adoption of a blanket approach to comment k in the first instance. For example, the terse opinion in Hahn does not so much as mention, let alone evaluate, the reasons why many other jurisdictions had interpreted comment k to require a case-by-case assessment concerning the availability of its protections. Compare, e.g., Hahn, 543 Pa. at 560–63673 A.2d at 889–91,with Toner, 732 P.2d at 304–09.

We emphasize that we are not revisiting Hahn; rather, our point is only that the truncated analysis in the Hahn line offers a poor foundation for extrapolation. See generally infra section IV.

Lance, 85 A.3d at 452 n. 21 (internal citations as in original).  Nor does the language from Tincher that was apparently being cited:

In either case, this jurisdiction’s experience with the repercussions of attempting to articulate specific principles of liability of broad application in implementing the strict liability cause of action make us reticent to go far beyond the necessities of an individual case and embrace a broad new approach premised upon what may prove to be procrustean categorical restrictions.

Our reticence respecting the Third Restatement scheme is not a judgment on our part that, as a matter of policy, articulating categorical exemptions from strict liability is not a viable or desirable alternative. Courts, which address evidence and arguments in individual cases, are neither positioned, nor resourced, to make the kind of policy judgments required to arrive at an a priori decision as to which individual products, or categories and types of products, should be exempt.

Tincher, 104 A.3d at 396.

What followed was a bizarre discourse on how drugs are “intrinsically dangerous” because they “are comprised of biologics meant to interact with and have an effect upon human tissue.”  2022 WL 3357485, *2.  On the purportedly other hand,

Medical devices, at least before implantation, are inert.  They may not remain so, and their insertion may trigger a systemic response from the patient’s body, but their physical characteristics are significantly different from medications.  If, with proper choice of materials and proper methods of fabrication, an implant can be supplied that is not inherently dangerous, then the rationale behind comment k does not readily apply.

Id.  The typical allegations in surgical mesh cases might be instructive.  So might the statutory definition of a medical device, which includes an instrument that is “intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals.”  21 U.S.C. § 321(h).

Following this bit of shoddy analysis, the Spear court turned to plaintiffs’ failure to warn claim.  After blindly applying its prior reasoning on strict liability design defect to strict liability failure to warn, the court gave a cursory analysis of whether plaintiffs had properly pled their claim.  With a time warp worthy of Riff Raff and Magenta, the court managed to ignore TwIqbal in its analysis.  Instead, it looked to Pennsylvania’s ultimate requirement of proof of expert testimony to prove a prescription drug (!!!) failure to warn claim as a reason why these plaintiffs did not have to plead a viable claim for failure to warn up front.  Id. at *2.  This creative reasoning is quite contrary to TwIqbal.  Many tort claims, and pretty much all product liability claims, will ultimately require expert support, yet those plaintiffs still have to meet Rule 8 pleading standards.  It certainly does not take an expert to write some allegations that “The device’s Instructions for Use did not advise physicians of the true risk of [whatever allegedly happened to this particular plaintiff].  If they had, then Dr. [whatever the name of the implanting surgeon was] would not have implanted the device in plaintiff.”  This plaintiff did not even do this much and the Spear opinion does not provide the information to fill in those brackets.

Next up was the Lance claim for “negligent design.”  The court acknowledged that “Some decisions in this district deem [Lance language describing negligence in broad terms] to be dicta, and interpret Lance as limiting negligent design claims involving medical products solely to the theory that the product was too dangerous to market.”  Id. at *3.  Yet the court followed the other (minority) view that Lance opened the door to “a broader theory of liability to include the claim that sound design requires the product to be accompanied by warnings.”  Id.  It clearly did not.  Summary judgment on negligent failure to warn in Lance, which was not overturned on appeal, is what led to Lance’s creation of a new non-warnings claim in the first place.  As Spear’s remaining discussion of the issue showed, the court did not understand the difference between a warnings claim, a design claim, and the claim that the product should not have been sold at all.  Strangely, in a footnote on whether pleading an alternative design was required, the court noted that language in a Lance footnote was “best understood as related to the Court’s approval of a theory not previously recognized by Pennsylvania law:  that some products are too dangerous to market.”  Id. at *3 n.6.  We could go on, but we will refrain.

After dismissing warranty claims because plaintiff did not oppose that portion of defendants’ motion, the court seems to have discovered Rule 9, specifically (b), in considering plaintiff’s negligent misrepresentation claim.  We do not have a problem with the result—plaintiff had not provided sufficient detail, but got a chance to amend—although the reasoning left something to be desired.  Without deciding whether 9(b)’s heightened pleading standards apply to a negligent misrepresentation claim, the court cited 2001 and 2007 Eastern District of Pennsylvania cases for a “degree of specificity” standard.  If the court decides future motions to dismiss or for summary judgment, then we hope it can be more rigorous and look to recent law, including from relevant courts like the United States Supreme Court.