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

We truly dislike decisions that find that claims of failure to report adverse events to the FDA are non-preempted, parallel violation failure to warn claims. Failure to report claims are not parallel.  Federal law does not require warnings to plaintiff or her doctors.  State law does not require warnings to the FDA. In the absence of a state-law duty to make reports to a government agency, a failure to report claim is an improper private attempt to enforce the FDCA. It is a claim that should not survive either express or implied preemption.

But, some courts do allow it, such as Bull v. St. Jude Medical, Inc., 2018 WL 3397544 (E.D. Pa. Jul. 12, 2018). Now, we think the Bull court is overstating when it says “most courts” to have considered a failure to report claim have found it to be a parallel claim. We refer you to our PMA Preemption scorecard which clearly shows this is an issue on which courts are split. Nor is the reasoning of the opinion anything new. Defendant had a duty under state law to warn physicians and a duty under federal law to comply with adverse event reporting requirements and those two requirements aren’t in conflict with each other. Id. at *8. But just because two roads don’t intersect doesn’t mean they are parallel.

And, because Pennsylvania doesn’t recognize a state law failure to report claim, any such claim exists solely as a result of the FDCA and therefore should also be impliedly preempted. Again, having concluded there are parallel duties, Bull also concludes no implied preemption. The court found that plaintiff alleged a valid state law failure to warn claim that was based on a failure to comply with its federal duty to report adverse events to the FDA. Id. at *9.

We don’t like those conclusions, but it’s also not the first time we’ve seen them. Where we usually take solace is that more often than not a finding that a failure to report claim is not preempted is followed by a finding that it is also not adequately pleaded. We refer you back again to the PMA Preemption scorecard for the many, many decisions reaching that conclusion. The primary reason the claim fails TwIqbal – failure to sufficiently plead causation.

Unfortunately, the court in Bull gave plaintiff a pass on pleading physician-specific warning causation. The complaint “does not even allege that [plaintiff’s] doctors consulted the [FDA adverse event] database, or any other source of . . . adverse event reports, when making their treatment decisions.” Id. But the court found that unnecessary. Instead, all that was required was an allegation that prior to the implantation of the device in plaintiff, defendant failed to disclose adverse events that if disclosed may have led her doctor’s not to use the device. Id.

That shouldn’t be enough. Even Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc), which allowed a failure to report claim, acknowledged that causation is a particularly problematic hurdle for plaintiffs:

Because they predicate their claim on [defendant’s] reporting duty to the FDA, as they must to avoid express preemption, [plaintiffs] face a causation hurdle that would not otherwise exist.  To prevail, they will ultimately have to prove that if [defendant] had properly reported the adverse events to the FDA as required under federal law, that information would have reached [the prescribing] doctors in time to prevent [plaintiffs’] injuries.

Stengel, 704 F.3d at 1234-35 (concurring opinion). Therefore, the causal chain requires both that the FDA would do something differently (such as make the adverse events public), and that that hypothetical action by the FDA would have caused the prescriber, in turn, to change his/her prescribing decision in some way that would have prevented the claimed injuries. Plaintiff’s allegations in Bull, as set forth in the opinion, are much too vague to support a plausible causation claim.

And the analysis shouldn’t have stopped there. The opinion actually sets forth sufficient facts that were pleaded to support reaching just the opposite conclusion on causation.

First, would the FDA would have done something differently? Plaintiff had the device implanted in 2010 and began experiencing problems with it in 2015. Bull at *5. Per the facts alleged, in 2009 the FDA conducted an inspection of defendant’s manufacturing facility. Id. at *2. The report of that inspection included information about Medical Device Reports (MDRs) that were either untimely or not submitted to the FDA. Id. at *3. It also included an analysis of MDRs both at the company and within the FDA’s database. Id. at *2-3. So, what the facts establish is that the FDA became aware of these adverse events a year before plaintiff received the device and at no time prior to plaintiff’s surgery did the FDA require defendant to take any further action to warn physicians beyond the existing labeling and warnings. So there is no causal nexus between the alleged failure to report and plaintiff’s injury.

Moreover, to the extent plaintiff relies on a 2011 FDA Safety Officer Report and a 2012 483 Inspection, those took place after plaintiff was implanted with the device and if they involve allegedly unreported events after 2010 – they can have no bearing on causation. To establish causation plaintiff should be required to prove (and plead) that had the adverse events been properly reported to the FDA, the information would have reached plaintiff’s physician in time to prevent the alleged injuries.

Second, would plaintiff’s doctors have done something differently? Well, because the FDA didn’t take action the answer is there is nothing to trigger plaintiff’s doctors doing anything different either. But, there is also the added fact that in this case after the events were reported and the FDA did require some additional warnings and even after the FDA recalled the device – plaintiff’s doctors did not explant the device. Id. at *5. While we are only privy to what’s reported in the complaint, we think the second link in the causal chain is likely broken as well.

We have a hard time imagining this case getting beyond summary judgment on causation based on what we see as the regulatory history from the opinion. We’ve talked in greater detail about this causation hurdle in failure to report cases here. So, while defendant lost at this stage, we are optimistic about a win in the future.

We’ve already unloaded on Hammons v. Ethicon, Inc., ___ A.3d ___, 2018 WL 3030754 (Pa. Super. June 19, 2018), where the court made a virtually unprecedented holding that a defendant challenging personal jurisdiction on Due Process grounds had the burden of proof in the course of allowing a litigation tourist from Indiana to stay in Pennsylvania, based on “contacts” that had no causal relationship to that plaintiff’s injuries.  Hammons involved high profile mass tort litigation, and we’re sure the story there is far from over.

Now there’s Webb-Benjamin, LLC v. International Rug Group, LLC, ___ A.3d ___, 2018 WL 3153602 (Pa. Super. June 28, 2018), a small commission dispute case involving a single event in Canada.  Heck, the non-resident defendant was not even registered in Pennsylvania until after the events in question.  Id. at *1.  In Webb-Benjamin, another panel of the same court has ruled that a corporation’s mere act of registering to do business in Pennsylvania subjected it to general personal jurisdiction, supposedly because registration equals “consent” and consent is a separate basis for personal jurisdiction not subject to the Due Process analysis.

Webb-Benjamin relied almost exclusively on Bors v. Johnson & Johnson, 208 F. Supp.3d 648 (E.D. Pa. 2016) (which we criticized here), and an asbestos case following Bors, Gorton v. Air & Liquid Systems Corp., 303 F. Supp.3d 278 (M.D. Pa. 2018). Webb-Benjamin, 2018 WL 3030754, at *4.  Thus,

Guided by the reasoning in Bors and Gorton, we conclude that [Bauman] does not eliminate consent as a method of obtaining personal jurisdiction.  Accordingly, pursuant to 42 Pa. C.S.A. §5301, Pennsylvania may exercise general personal jurisdiction over [plaintiff’s] claims against [defendant].

Id. at *5.

The analysis in Webb-Benjamin and the two district court cases is fairly simple.  First, the aforementioned §5301(a) “qualification as a foreign entity under the laws of this Commonwealth” is a “sufficient basis . . . to exercise general personal jurisdiction over such person.”  Second, registration is a form of “consent” to personal jurisdiction.  Third, “consent” is distinct ground for general personal jurisdiction not subject to the ordinary general jurisdiction tests enunciated in Daimler AG v. Bauman, 571 U.S. 117 (2014).  That’s simple, but also simply wrong.

First, the statute says what it says.  But a state statute cannot trump federal Due Process – that’s what the Supremacy Clause is all about.  Thus, Judge New recognized that to interpret the state’s registration statute in this fashion renders it unconstitutional as applied to a non-resident corporation being sued by a non-resident plaintiff over activities outside the state of Pennsylvania:

Under the current state of Pennsylvania law, the only way foreign corporations such as Defendant can avoid Pennsylvania courts’ assertion of general jurisdiction over them is for those corporations to avoid doing business in Pennsylvania.  Faced with this Hobson’s choice, a foreign corporation’s consent to general jurisdiction in Pennsylvania can hardly be characterized as voluntary.  In light of the Supreme Court’s repeated admonishment that the Due Process Clause prohibits a state from claiming general jurisdiction over every corporation doing business within its borders, it logically follows the Due Process Clause also prohibits a state from forcing every corporation doing business within its borders to consent to general jurisdiction.

Mallory v. Norfolk Southern Railway Co., 2018 WL 3025283, at *5 (Pa. C.P. Phila. Co. May 30, 2018) (citations omitted).  The United States Supreme Court has repeatedly stated that a corporate defendant must be “at home” in order to justify general jurisdiction – not merely that it conduct “continuous and substantial” business.  E.g., BSNF Railway. v. Tyrrell, 137 S.Ct. 1549 (2017); Daimler AG v. Bauman, 571 U.S. 117 (2014); Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915 (2011).

Personal jurisdiction, “represents a restriction on judicial power . . . as a matter of individual liberty.”  Insurance Corp. of Ireland v. Compagnie des Bauxites de Guinee, 456 U.S. 694, 702 (1982).  A mere state statute cannot change federal constitutional law.  “By wrapping general jurisdiction in the cloak of consent, Pennsylvania’s mandated corporate registration attempts to do exactly what the United States Supreme court prohibited.”  Mallory, 2018 WL 3025283, at *6.  Indeed, the same Pennsylvania statute expressly recognizes Due Process limitations.  See 42 Pa. Cons. Stat. §5308 (“tribunals of this Commonwealth may exercise jurisdiction under this subchapter only where the contact with this Commonwealth is sufficient under the Constitution of the United States”); 42 Pa. C.S.A. §5307 (jurisdiction only extends “to the extent permitted by the Constitution of the United States”).

Nor does Webb-Benjamin’s step two accurately state the law.  The Pennsylvania statute itself treats registration and consent as separate means of obtaining general jurisdiction.

(a) General rule. − The existence of any of the following relationships . . . shall constitute a sufficient basis . . . [for] general personal jurisdiction. . . .

(i) Formation under or qualification as a foreign entity under the laws of this Commonwealth.

(ii) Consent, to the extent authorized by the consent.

(iii) The carrying on of a continuous and systematic part of its general business within this Commonwealth.

42 Pa. C.S. §5301(a)(1-3) (emphasis added).  On its face, the statute plainly distinguishes between registration and consent.  They are different bases for jurisdiction.  Webb-Benjamin improperly merges subsections (a)(i) and (a)(ii).

Nor does the United States Supreme Court currently (as opposed to 100 years ago) consider registration to do business as a form of consent.  Generally, the Court has dispensed with “the fiction[] of implied consent to service on the part of a foreign corporation” in favor of “ascertain[ing] what dealings make it just to subject a foreign corporation to local suit.”  Shaffer v. Heitner, 433 U.S. 186, 202-03 (1977).

We initially upheld these [corporate registration] laws under the Due Process Clause on grounds that they complied with Pennoyer’s rigid requirement of either “consent,” or “presence.”   As many observed, however, the consent and presence were purely fictional.

Burnham v. Superior Court, 495 U.S. 604, 617-18 (1990) (citations omitted).

Further, in Insurance Corp. of Ireland, the Court listed the currently recognized ways by which a defendant could “consent” to personal jurisdiction in the forum:  (1) “submi[ssion] to the jurisdiction of the court by appearance”; (2) “parties to a contract may agree in advance to submit to the jurisdiction of a given court”; (3) “a stipulation entered into by the defendant”; (4) “agreements to arbitrate”; (5) “a judgment in personam may be rendered in a cross-action against a plaintiff in its courts”; (6) “waive[r] if not timely raised”; and (7) “fail[ure] to comply with a pretrial discovery order.”  456 U.S. at 705-06.  Corporate registration to do business is conspicuously absent from this list.  See also J. McIntyre Machinery, Ltd. v. Nicastro, 564 U.S. 873, 880-81 (2011) (more recent discussion of consent likewise omitting corporate registration).  Registration is not consent.  To the contrary, a state may not “requir[e] the corporation, as a condition precedent to obtaining a permit to do business within the State, to surrender a right and privilege secured to it by the Constitution.”  Koontz v. St. Johns River Water Management District, 570 U.S. 595, 607 (2013) (quoting Southern Pacific Co. v. Denton, 146 U.S. 202, 207 (1892)).

To conduct any business in Pennsylvania, however slight, a foreign corporation must register. 15 Pa. C.S. §412(a).  All 50 states and the District of Columbia have similar laws.  E.g., T. Monestier, “Registration Statutes, General Jurisdiction, & the Fallacy of Consent,” 36 Cardozo L. Rev. 1343, 1363-64 n.109 (2015) (string cite of all 50 states’ registration statutes).  Thus, if an authorizing statute was sufficient to create general jurisdiction – whether called “consent” or anything else – a corporation could constitutionally be subjected to general jurisdiction in every state where they conducted business, whether or no not the business was “continuous and substantial” – indeed even if they actually did no business at all (recall that the defendant in Webb-Benjamin only registered after the events at suit).  That result is incompatible with Bauman, which held that to “approve the exercise of general jurisdiction in every State in which a corporation engages in a substantial, continuous, and systematic course of business” would be “unacceptably grasping.”  571 U.S. at 138 (quotation marks omitted).  Since Webb-Benjamin’s “consent” theory does not even require “continuous and substantial” corporate activity as a predicate to general jurisdiction, Due Process does not allow theories of jurisdiction that would expose a corporation to suit for anything in any state:

[T]he same global reach would presumably be available in every other State. . . .  Such exorbitant exercises of all-purpose jurisdiction would scarcely permit out-of-state defendants to structure their primary conduct with some minimum assurance as to where that conduct will and will not render them liable to suit.

Id. at 139 (citation and quotation marks omitted).  “A corporation that operates in many places can scarcely be deemed at home in all of them.”  Id. at 139 n.20.  “[I]n-state business . . . does not suffice to permit the assertion of general jurisdiction.”  Tyrell, 137 S. Ct. at 1559.

Unlike Webb-Benjamin, almost every other appellate court in the country has read the Supreme Court’s decisions in BSNF, Bauman, and Goodyear to mean what they say, and has recognized the handwriting on the wall against expansive jurisdiction by consent theories.  We’ll start with Genuine Parts Co. v. Cepec, 137 A.3d 123 (Del. 2016), since:  (1) Delaware knows something about corporate law, and (2) until Bauman, Delaware law had recognized precisely the same consent theory of jurisdiction as Webb-Benjamin.  No longer.  Cepec understood that general jurisdiction by consent merely by means of registration to do business is incompatible with Bauman:

An incentive scheme where every state can claim general jurisdiction over every business that does any business within its borders for any claim would reduce the certainty of the law and subject businesses to capricious litigation treatment as a cost of operating on a national scale or entering any state’s market.  [Bauman] makes plain that it is inconsistent with principles of due process to exercise general jurisdiction over a foreign corporation that is not “essentially at home” in a state for claims having no rational connection to the state.  The foreign corporation in this case does not have its principal place of business in Delaware; nor is there any other plausible basis on which Delaware is essentially its home.  Hence, Delaware cannot exercise general jurisdiction over it consistent with principles of due process.

137 A.3d at 127-28 (footnote omitted)

General jurisdiction by consent was likewise rejected in State ex. rel. Norfolk Southern Railway Co. v. Dolan, 512 S.W.3d 41, 51-53 (Mo. 2017).  The court first observed, citing Cepec, that “a broad inference of consent based on registration would allow national corporations to be sued in every state, rendering [Bauman] pointless.”  Id. at 51.  It therefore refused to interpret its statute to raise such constitutional questions.  “The plain language of Missouri’s registration statutes does not mention consent to personal jurisdiction for unrelated claims.”  Id. at 52. Accord State ex rel. Bayer Corp. v. Moriarty, 536 S.W.3d 227, 232-33 (Mo. 2017) (following Dolan in prescription medical product case).

Similarly, the Illinois Supreme Court, in Aspen American Insurance Co. v. Interstate Warehousing, Inc., 90 N.E.3d 440 (Ill. 2017), rejected the proposition that corporate registration creates general jurisdiction:

[T]hat a foreign corporation registered to do business in Illinois is subject to the same duties as a domestic one in no way suggests that the foreign corporation has consented to general jurisdiction. . . .  [T]hat a foreign corporation has registered to do business under the Act does not mean that the corporation has thereby consented to general jurisdiction over all causes of action, including those that are completely unrelated to the corporation’s activities in Illinois.

Id. at 447-48.  Accord Campbell v. Acme Insulations, Inc., ___ N.E.3d ___, 2018 WL 2305692, at *4 (Ill. App. May 18, 2018) (“Nor does the fact that [defendant] has a registered agent for service of process in Illinois show that it consented to jurisdiction in this State”) (following Aspen).

In the otherwise unfortunate Bristol-Myers Squibb Co. v. Superior Court, 377 P.3d 874 (Cal. 2016), reversed, 137 S. Ct. 1773 (2017), the California Supreme Court likewise held that “a corporation’s appointment of an agent for service of process, when required by state law, cannot compel its surrender to general jurisdiction for disputes unrelated to its California transactions.”  Id. at 798.  See also Am Trust v. UBS AG, 681 F. Appx. 587, 589 (9th Cir. 2017) (consent to jurisdiction not required of corporations registering to do business) (applying California law).  The same conclusion governs Wisconsin law.  In Segregated Account of Ambac Assurance Corp. v. Countrywide Home Loans, 898 N.W.2d 70 (Wis. 2017), the court overturned lower court precedent, cautioning that it “generally avoids interpreting statutes in a way that places their constitutionality in question,” which was precisely basing general jurisdiction on corporate registration would do:

The shade of constitutional doubt that Goodyear and [Bauman] cast on broad approaches to general jurisdiction informs our assessment of this court’s older cases. . . .  Significantly, the [Bauman] Court cautioned that “cases decided in the era dominated by Pennoyer’s territorial thinking should not attract heavy reliance today.”  134 S.Ct. at 761 n.18 (citation omitted). . . .  [W]e  instead give preference to prevailing due process standards when interpreting a contemporary statute for the first time. . . .  [S]ubjecting foreign corporations to general jurisdiction wherever they register an agent for service of process would reflect the “sprawling view of general jurisdiction” rejected by the Supreme Court.

Id. at 82.  Accord Figueroa v. BNSF Railway Co., 390 P.3d 1019, 1021-22 (Or. 2017) (“we conclude that appointing a registered agent to receive service of process merely designates a person upon whom process may be served.  It does not constitute implied consent to the jurisdiction of the Oregon courts.”); Magill v. Ford Motor Co., 379 P.3d 1033, 1038 (Colo. 2016) (corporate registration cannot support general jurisdiction where defendant’s in-state contacts “pale in comparison to the significant contacts that were deemed ‘slim’ in” Bauman).

So that’s seven state high courts rejecting general jurisdiction based on considering registration to do business as “consent” since Bauman – to zero in favor.

Appellate authority in other jurisdictions is in accord with the above decisions.  The Second Circuit in Brown v. Lockheed-Martin Corp., 814 F.3d 619 (2d Cir. 2016) (applying Connecticut law), refused to “err[] in casually dismissing related federal due process concerns” and became the first post-Bauman appellate decision to reject “consent” based on mere registration to do business as a basis for general personal jurisdiction.  Id. at 636.  “[T]he history of such statutes suggests that assent only to specific jurisdiction is what the statute required.” Id. at 637. So-called “consent” jurisdiction, if generally conferred by registration to do business raises the same constitutional concerns that drove the result in Bauman:

In any event, we can say that the analysis that now governs general jurisdiction over foreign corporations − the Supreme Court’s analysis having moved . . . to the more demanding “essentially at home” test . . . − suggests that federal due process rights likely constrain an interpretation that transforms a run‐of‐the‐mill registration and appointment statute into a corporate “consent” − perhaps unwitting − to the exercise of general jurisdiction by state courts.

Id.  “If mere registration and the accompanying appointment of an in state agent – without an express consent to general jurisdiction – nonetheless sufficed to confer general jurisdiction by implicit consent, every corporation would be subject to general jurisdiction in every state in which it registered, and [Bauman’s] ruling would be robbed of meaning by a back‐door thief.”  Id. at 640.  See also Wal-Mart Stores, Inc. v. Lemaire, 395 P.3d 1116, 1120 (Ariz. App. 2017) (“there is no need to base personal jurisdiction solely upon a murky implication of consent to suit − for all purposes and in all cases − from the bare appointment of an agent for service.  We therefore agree with those decisions holding that registration statutes do not imply consent to general jurisdiction.”); Magwitch, LLC v. Pusser’s West Indies, Ltd., 200 So.3d 216, 218 (Fla. App. 2016) (registration cannot create general jurisdiction; old law “has yielded to the two-prong analysis for long-arm jurisdiction set forth in recent decades by the Supreme Court”); Dutch Run Mays Draft, LLC v. Wolf Block LLP, 164 A.3d 435, 444-45 (N.J. App. Div. 2017) (court could not “agree business registration rises to consent to submit to the general jurisdiction in the forum,” given Bauman’s “clear narrow application of general jurisdiction”); Stisser v. SP Bancorp, Inc., 174 A.3d 405 (Md. App. 2017); Salgado v. OmniSource Corp., 2017 WL 4508085, at *5 (Tex. App. Oct. 10, 2017) (having a “registered agent in Texas . . . [alone] is not enough to subject a nonresident defendant to general jurisdiction”) (unpublished); Northern Frac Proppants, II, LLC v. 2011 NF Holdings, LLC, 2017 WL 3275896, at *16 (Tex. App. July 27, 2017) (“general jurisdiction contacts are not established by showing that foreign business entities . . . were registered to do business in Texas, and had registered agents for service of process in Texas”) (unpublished); Gulf Coast Bank & Trust Co. v. Designed Conveyor Systems, LLC, 717 F. Appx. 394, 398 (5th Cir. 2017) (rejecting “other outdated view[s] of general jurisdiction”; no general jurisdiction by reason of corporate registration) (applying Louisiana law).

There are literally dozens of trial court level decisions in numerous other states that also reject corporate registration as a basis for general jurisdiction when a corporate defendant is not “at home” under Tyrell/Bauman.  For prior decisions, see our 50-state survey on jurisdiction by consent.  For future decisions (not divided by state) see our post-BMS jurisdictional cheat sheet.

With WebbBenjamin, those of us who defend cases in Pennsylvania now have to cope with loopy Superior Court decisions on both general and specific jurisdiction.  Pennsylvania’s prior reputation as a hotbed of litigation tourism remains well and fairly earned.  Expect multiple appeals to the Pennsylvania Supreme Court, and perhaps even higher, to the United States Supreme Court.

Today’s guest post is by Reed Smith associate Regina Nelson.  In it she tackles an issue that inevitably arises whenever ediscovery for defendants is successful, that is, what must be done to have the fruits of that discovery be admitted at trial, otherwise known as authentication.  She discusses a recent Pennsylvania appellate case that addressed this issue.  As always our guest bloggers are 100% responsible for their posts, and deserving of all the credit (and any blame) for what they write.

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Social media is ubiquitous.  Almost everyone knows someone who is a member of Facebook, Twitter or Instagram, even those of us who do not use these services personally.  As people post about their comings and goings or opinions on social media, it is not surprising that they are becoming an issue in both civil and criminal cases.  The blog has a cheat sheet, “Ediscovery for Defendants,” with over 100 decisions, devoted to discovery of plaintiffs’ social media.

In a recent case of first impression in Pennsylvania, the Superior Court in a criminal case Commonwealth v. Mangel, 181 A.3d 1154 (Pa. Super. Ct. Mar. 15, 2018), discussed what lawyers need to do at trial to authenticate an opponent’s social media pages – in this case, on Facebook.  While Mangel applied Pennsylvania law, it is potentially relevant to federal cases as well because Pennsylvania Rule of Evidence 901 is almost identical to Federal Rule of Evidence 901.

Under Pennsylvania Rule of Evidence 901, authentication is a prerequisite  to admission of most evidence.  Like the federal rule, the standard is adequate proof that the evidence is what it purports to be.  Usually testimony is enough to authenticate evidence.  Evidence can also be authenticated by other methods, including circumstantially.  Id. at 1159.  Admissibility of electronic communications is evaluated on a case-by-case basis.  Merely showing that the electronic communication belonged to someone was not sufficient to authenticate it.  See Commonwealth v. Koch, 39 A.3d 996, 1005 (Pa. Super. Ct. 2011).  Mangel addressed how much circumstantial evidence was sufficient to corroborate the identity of the sender.

In Mangel, the trial court had denied a Motion in Limine to admit Facebook posts and messages allegedly authored by the defendant in an assault and battery case.  Id. at 1155.  The alleged victim could identify the defendant from Facebook pictures.  Id. at 1155-56.  The social media evidence at issue was:  (1) screenshots of certain Facebook account pages in the name of the defendant, and (2) a Facebook screenshot of a photograph of purportedly bloody hands had been posted by another person.  Id. at 1156.

To authenticate the Facebook evidence, the prosecution relied on a qualified expert in computer forensics.  Id.  After researching Facebook and finding a relevant account, the expert determined that the Facebook account she located with a search for the defendant’s name also matched that of the Facebook pages provided to her by the Commonwealth.  Id.  That identification evidence was significantly undermined on cross-examination, however.  First, the prosecution expert conceded that she could not say to a reasonable degree of certainty that the defendant, and not someone else, authored the posts.  Id. at 1157.  Second, the expert failed to obtain an IP address for the account in question.  Id.   Third, the expert was impeached by defense counsel with a Facebook search showing multiple accounts for someone with the same name as the Defendant.  Id.  After hearing this testimony, the trial court denied the Motion in LimineId.

The Superior Court in Mangel expressed concerns about authorship of the Facebook pages and posts similar to the Koch case, which it discussed at some length.  Id. at 1160.  To authenticate social media evidence, the  prosecution had to present direct or circumstantial evidence corroborating the identity of the on-line author.  Id. at 1161.  Critically, the defendant in Mangel did not concede at any time that the Facebook account was his or that he authored the posts.  Id. at 1163.  Establishing authorship was key due to the nature of social media.  “[T]he same authorship concerns . . . in relation to e-mails and instant messages, exist in reference to Facebook and other social media platforms, that can be accessed from any computer or smart phone with the appropriate user identification and password.”  Id. at 1162.  Another failing by the prosecution only compounded its expert’s weaknesses.  It never obtained the username or password for the Facebook account to confirm its authenticity.  Id. at 1163.  That a Facebook page contained the defendant’s name, hometown and school was not sufficient to establish that the defendant actually authored the posts on the page.

The mere fact that the Facebook account in question bore [defendant’s] name, hometown and high school was insufficient to authenticate the online and mobile device chat messages as having been authored by [him].  Moreover, there were no contextual clues in the chat messages that identified [him] as the sender of the messages.

Id. at 1164.

In addition to concerns about identity and authorship, issues also arose with the content of the messages and posts.  Id. at 1163-64.  Nothing established the time the posts and messages were created.  Id. at 1163.  Absence of a timestamp precluded confirmation that the posts were made in connection with the alleged incident.  Id. at 1163-64.  The Facebook posts were ambiguous in that they did not specifically reference the defendant.  Id. Finally, the posts and messages were devoid of any “distinct characteristics” indicative of the author’s personal style that might have corroborated the defendant as their author. Id.

Thus, the Superior Court agreed with the trial court’s decision.  There must be affirmative evidence that the defendant was the actual sender of the messages.  Id. at 1164. Mangel should serve as a reminder that locating seemingly relevant social media evidence is only the first, not the last step.    Social media evidence must also be authenticated before it will be admitted into evidence.  By all means, learn from the mistakes made by the prosecutors in Mangel.

To avoid a similar situation, those seeking to authenticate social media should consider taking certain steps:

  • Establish who, other than the account owner, has access and/or authorship rights.  If such other persons exist, their actions must be excluded.
  • Seek authorship admissions from the owner.
  • If, as in Mangel, such admissions are not forthcoming, conduct additional investigations to exclude other potential authors.
  • If Facebook messenger or some other messaging tool is involved, similarly establish authorship of relevant posts.
  • If necessary, depose the non-authoring recipients of messages to confirm their knowledge of the sender’s identity.
  • Obtain relevant IP addresses of social media evidence, ideally from material provided by the social network operator.
  • Obtain timestamps, or other temporal data, again from the website operator.
  • Obtain available metadata from the operator and have it forensically reviewed.
  • Hire a competent expert, knowledgeable about the applicable certainty standards for opinions, who will not wilt under cross-examination.
  • Include questions about the contents of the social media at issue, such as identification of photographs, in deposition outlines for witnesses other than the account owner.
  • If slang is an obstacle, have slang interpreted by the account owner and (if necessary) others during discovery.

We were reading the appallingly bad personal jurisdiction (and other things, but those aren’t what we’re interested in today) decision in Hammons v. Ethicon, Inc., ___ A.3d ___, 2018 WL 3030754 (Pa. Super. June 19, 2018).  While many of the jurisdictional issues in Hammons are factually limited to the particular defendant and the particular product, one holding made us drop what we were doing and turn to research.

That question is very simple – who has the burden of proof where the issue is whether a plaintiff’s assertion of personal jurisdiction violates Due Process.

Hammons held:

A defendant making a challenge to the court’s personal jurisdiction has, as the moving party, the burden of supporting its objection to jurisdiction.

2018 WL 3030754, at *6 (quoting De Lage Landen Services, Inc. v. Urban Partnership, LLC, 903 A.2d 586, 589 (Pa. Super. 2006)) (emphasis added).

This holding − that the defendant, not the plaintiff who asserted jurisdiction in the first place, has the burden of proof when a constitutional challenge to personal jurisdiction is raised – is virtually unprecedented and contrary to practically all the cases we have seen addressing this issue. It also seems intuitively wrong, since analogous issues, such as subject matter jurisdiction, standing, and the admissibility of evidence, impose the ultimate burden of proof on the party advocating jurisdiction or admissibility of evidence, even though the opposing party usually makes the motion to have the issue decided.

Moreover, in Hammons we think that the burden of proof question matters.  Much of Hammons revolves around the same third-party contractor issue that we recently discussed in this post about another adverse jurisdictional decision from the same Philadelphia mass tort.  Although Hammons tries harder to disguise the lack of causal relationship between what the third party did (knitting the mesh together) and any design or manufacturing claim actually asserted by the plaintiff (see 2018 WL 3030754, at *9 (defendant “worked together” with the third-party “in Pennsylvania to design, test and manufacture the” product), the problem we identified in the prior post still exists – Hammons never states how this third-party’s activities contributed to the particular defect/injuries alleged by this plaintiff.  None of the “specifications” for the knitting originated with the Pennsylvania entity, but rather with the defendant. Id. (“knitted . . ., and tested samples for, compliance with [defendant’s] specifications”).

Ultimately, we don’t think that the Superior Court’s proposition – that any allegation of “design” or “manufacturing” defect allows jurisdiction to rest on any arguably in-state “design” or “manufacturing”-related activities where those activities don’t have anything to do with what allegedly injured the plaintiff – flies under Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017) (“BMS”).

But there’s a second set of allegations in Hammons, that the defendant “relied heavily on an Allentown, Pennsylvania gynecologist . . . for the development, study, and marketing of [the product].”  Id.

Those facts, whether significant or wildly overblown, were nonetheless “trial evidence,” id. − meaning that plaintiff did not assert them in opposition to the defendant’s previous jurisdictional motion.  The court’s excuse for considering them was:

We may affirm on any ground.  Thus, we need not confine our reasons for affirming to evidence adduced during proceedings on [defendant’s] preliminary objections to jurisdiction.

Id. at 9 n.6 (citation and quotation marks omitted).

That’s fine if the defendant bears the burden of proof, and is thus responsible for ensuring a complete jurisdictional record.  But if the plaintiff bore the burden of proof in Hammons, then the plaintiff had the obligation to complete the jurisdictional record in a timely fashion, and it would not be proper for an appellate court to decide the jurisdictional issue on facts that the trial court did not have before it because the plaintiff failed to present them.  Reliance on such after-the-fact facts is called “sandbagging,” and is generally frowned upon. E.g., Com. v. Johnson, 456 A.2d 988, 996 (Pa. Super. 1983).  We can’t evaluate whether the extent of this Pennsylvania consulting was enough for this litigation tourist to remain in a Pennsylvania court under BMS, but we do believe that it was procedurally improper for an appellate court to consider it if the party being benefited bore (and thus failed to meet) the burden of proof on personal jurisdiction.

All this being said, we can’t say with 100% certainty that the Hammons burden of proof ruling is erroneous – because neither the United States Supreme Court nor the Pennsylvania Supreme Court appears to have decided the burden-of-proof question in the specific context of personal jurisdiction.  No controlling decision of a higher court was ignored – at least that we could find.

In researching this question, we (of course) looked at to United States Supreme Court and found very little.  In Burger King Corp. v. Rudzewicz, the Court phrased the inquiry in the passive voice, “[o]nce it has been decided that a defendant purposefully established minimum contacts within the forum State, these contacts may be considered.”  471 U.S. 462, 476 (1985).  So did Asahi Metal Industries Co. v. Superior Court, 480 U.S. 102, 114, (1987) (“[w]hen minimum contacts have been established”).  Such language neatly avoids the burden of proof question, and presumably arises because the Supreme Court is usually dealing with undisputed factual records.

We found even less precedent in the Pennsylvania Supreme Court – not even passive voice holdings.

However, review of Superior Court precedents shows that the Hammons position was not even the majority rule.  A majority of Pennsylvania Superior Court decisions hold something like this:

Once the moving party supports its objections to personal jurisdiction, the burden of proving personal jurisdiction is upon the party asserting it.

Schiavone v. Aveta, 41 A.3d 861, 865 (Pa. Super. 2012) (quoting Gaboury v. Gaboury, 988 A.2d 672, 675 (Pa. Super. 2009) (emphasis added), aff’d, 91 A.3d 1235 (Pa. 2014) (per curiam).  See N.T. v. F.F., 118 A.3d 1130, 1134 (Pa. Super. 2015) (also quoting Gaboury); Sulkava v. Glaston Finland Oy, 54 A.3d 884, 889 (Pa. Super. 2012) (“Once the moving party supports its objections to personal jurisdiction, the burden of proving personal jurisdiction is upon the party asserting it.”); Mendel v. Williams, 53 A.3d 810, 816 (Pa. Super. 2012) (quoting Schiavone); Taylor v. Fedra International, Ltd., 828 A.2d 378, 381 (Pa. Super. 2003) (“Once the moving party supports its objections to personal jurisdiction, the burden of proving personal jurisdiction is upon the party asserting it.”); Barr v. Barr, 749 A.2d 992, 994 (Pa. Super. 2000) (same); Grimes v. Wetzler, 749 A.2d 535, 540 (Pa. Super. 2000) (“Once the [defendants] supported their jurisdictional objection, the burden shifted to [plaintiff] to prove that there is statutory and constitutional support for the trial court’s exercise of jurisdiction.”); General Motors Acceptance Corp. v. Keller, 737 A.2d 279, 281 (Pa. Super. 1999) (”Once the movant has supported its jurisdictional objection, however, the burden shifts to the party asserting jurisdiction to prove that there is statutory and constitutional support for the court’s exercise of in personam jurisdiction.”); McCall v. Formu-3 International, Inc., 650 A.2d 903, 904 (Pa. Super. 1994) (“once the moving party has supported his objection to jurisdiction, the burden of proof shifts to the party asserting jurisdiction”); Rivello v. New Jersey Automobile Full Insurance Underwriting Ass’n, 615 A.2d 342, 343 (Pa. Super. 1994) (“once the defendant properly raises the issue of jurisdiction, the plaintiff has the burden of proving that jurisdiction is proper”); Derman v. Wilair Services, Inc., 590 A.2d 317, 319 (Pa. Super. 1991) (same); (“When, as here, a defendant properly raises an objection on the ground of a lack of in personam jurisdiction, the plaintiff has the burden of proving that the exercise of jurisdiction is permissible.”); Babich v. Karsnak, 528 A.2d 649, 654 (Pa. Super. 1987) (same); Bergere v. Bergere, 527 A.2d 171, 173 (Pa. Super. 1987) (“When a defendant raises lack of personal jurisdiction, it becomes the plaintiff’s burden to prove that the exercise of jurisdiction is permissible.”).  There are older cases, but you get the point….

We tried following the line of cases Hammons quoted to see how a contrary position originated.  That wasn’t hard.  We started with the De Lage case, which Hammons quoted.  The burden of proof didn’t really matter in De Lage, since that case affirmed dismissal for lack of personal jurisdiction.  903 A.2d at 592.  On the burden issue, De Lage in turn quoted (id. at 589-90) two cases: King v. Detroit Tool Co., 682 A.2d 313, 314 (Pa. Super. 1996) (for the proposition, “A defendant making a challenge to the court’s personal jurisdiction has, as the moving party, the burden of supporting its objection to jurisdiction”), and Gall v. Hammer, 617 A.2d 23, 24 (Pa. Super. 1992).  King cited Scoggins v. Scoggins, 555 A.2d 1314, 1317 (Pa. Super. 1989).

Taking Gall first, it’s not any different in content from the string cite we have above – only in organization and placement.  In the body of the opinion, Gall did indeed state, “When a defendant challenges the court’s assertion of personal jurisdiction, that defendant bears the burden of supporting such objections to jurisdiction by presenting evidence.”  617 A.2d at 24.  That may involve a burden of production, but not the ultimate burden of proof.  The “then what” proposition in Gall was dropped to a footnote.  “The burden of proof only shifts to the plaintiff after the defendant has presented affidavits or other evidence in support of its preliminary objections challenging jurisdiction.”  Id. at 24 n.2.  So Gall is not authority for holding that a defendant, alone, bears the burden of proof when personal jurisdiction is at issue.  Nor is Scroggins.  In that case, the court simply separated “if X” from “then Y.”  Here is the complete discussion in Scroggins, with the two propositions highlighted:

When a defendant wishes to challenge the court’s exercise of in personam jurisdiction, he may do so by filing preliminary objections.  As the moving party, the defendant, has the burden of supporting its objections to the court’s jurisdiction.

Once the plaintiff has produced some evidence to support jurisdiction, the defendant must come forward with some evidence of his own to dispel or rebut the plaintiff’s evidence.  The moving party may not sit back and, by the bare allegations as set forth in the preliminary objections, place the burden upon the plaintiff to negate those allegations.  Only when the moving party has properly raised the jurisdictional issue does the burden of proving jurisdiction fall upon the party asserting it.  Where an essential factual issue arises from the pleadings as to the scope of a defendant’s activities within the Commonwealth, the plaintiff has the right to depose defendant as to his activities within the Commonwealth.

555 A.2d at 1317-18 (multiple citations omitted) (emphasis added as described above).

Thus the Hammons holding that the defendant has the burden of proof − period – on personal jurisdiction is unwarranted even by Superior Court precedent.  It confuses the initial burden of production of evidence with the ultimate burden of proof.  Hammons, along with the case it quotes, misstates the burden of proof by omitting the holding of numerous prior Superior Court panels that, once the defendant puts on some evidence to support its jurisdictional position (which we’re sure was done), then the burden switches to the plaintiff to establish jurisdiction as “the party asserting it.”  That makes practical sense as well.  If plaintiffs didn’t bear the burden of proof, why would they need jurisdictional discovery?

The majority Pennsylvania rule, that the plaintiff bears the ultimate burden of proof on personal jurisdiction, is also the federal rule.  While the United States Supreme Court hasn’t decided the issue, the Courts of Appeals have done so many times, and appear to be unanimous in imposing the ultimate burden of proving personal jurisdiction on the plaintiff asserting it.  Here are a few of the many decisions (the search pulled up 881 cases):

To survive a motion to dismiss for lack of personal jurisdiction, a plaintiff must plead sufficient facts to support a reasonable inference that the defendant can be subjected to jurisdiction within the state.  But where, as here, the parties submit affidavits to bolster their positions on the motion, and the district court relies on the evidence, the motion is in substance one for summary judgment.  The plaintiff bears the burden of proof on the issue of personal jurisdiction, and must establish jurisdiction by a preponderance of the evidence at trial or when the court holds an evidentiary hearing.

Creative Calling Solutions, Inc. v. LF Beauty Ltd., 799 F.3d 975, 979 (8th Cir. 2015) (citations and quotation marks omitted).

It was [plaintiff’s] burden to convince the district court that it had jurisdiction over the persons of the defendants.  That is, [plaintiff] had to satisfy a threshold requirement, the prima facie establishment of jurisdiction.  The plaintiff bears the burden of establishing a prima facie case of jurisdiction over the movant, non-resident defendant.

PVC Windoors, Inc. v. Babbitbay Beach Construction, N.V., 598 F.3d 802, 810 (11th Cir. 2010) (citations and quotation marks omitted).

The plaintiff bears the burden of establishing” personal jurisdiction, and though he need only make a prima facie case at the Rule 12(b)(2) stage, his burden escalates to preponderance of the evidence by the end of trial.

In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, 888 F.3d 753, 778 (5th Cir. 2018) (citations and quotation marks omitted).

See also, e.g., John Crane, Inc. v. Shein Law Center, Ltd., 891 F.3d 692, 695 (7th Cir. 2018) (“When challenged, the plaintiff has the burden of proving personal jurisdiction.”) (citation omitted); Scottsdale Capital Advisors Corp. v. The Deal, LLC, 887 F.3d 17, 20 (1st Cir. 2018) (“a plaintiff must proffer evidence which, if credited, is sufficient to support findings of all facts essential to personal jurisdiction and may not rely on unsupported allegations”) (citation and quotation marks omitted); Friedman v. Bloomberg L.P., 884 F.3d 83, 90 (2d Cir. 2017) (“The plaintiff bears the burden of demonstrating that the court has personal jurisdiction over each defendant.”) (citation omitted); Anwar v. Dow Chemical Co., 876 F.3d 841, 847 (6th Cir. 2017) (“Plaintiffs have the burden of establishing that a district court can exercise jurisdiction over the defendant”); Morrill v. Scott Financial Corp., 873 F.3d 1136, 1141 (9th Cir. 2017) (“When a defendant moves to dismiss for lack of personal jurisdiction, the plaintiff bears the burden of demonstrating that jurisdiction is appropriate.”); Polar Electro Oy v. Suunto Oy, 829 F.3d 1343, 1348 (Fed. Cir. 2016) (“The plaintiff bears the burden of establishing minimum contacts”); Grayson v. Anderson, 816 F.3d 262, 268 (4th Cir. 2016) (“a plaintiff must establish facts supporting jurisdiction over the defendant by a preponderance of the evidence”) (citation omitted); Niemi v. Lasshofer, 770 F.3d 1331, 1347 (10th Cir. 2014) (“the plaintiff generally must establish, by a preponderance of the evidence, that personal jurisdiction exists”) (citation and quotation marks omitted); Williams v. Romarm, SA, 756 F.3d 777, 785 (D.C. Cir. 2014) (”[plaintiffs] have the burden of establishing a factual basis for the court’s exercise of personal jurisdiction over [defendant]”); Control Screening LLC v. Technological Application & Production Co., 687 F.3d 163, 167 (3d Cir. 2012) (“The plaintiff bears the burden to prove, by a preponderance of the evidence, facts sufficient to establish personal jurisdiction.”) (citation and quotation marks omitted).  That’s a clean sweep.  Every federal court of appeals imposes the ultimate burden of proof on plaintiffs in personal jurisdiction matters.

Finally, because of what personal jurisdiction represents, we think that the burden of proof should be on the plaintiff as a matter of policy.  Personal jurisdiction is an essential element of due process of law.  “Because ‘[a] state court’s assertion of jurisdiction exposes defendants to the State’s coercive power,’ it is ‘subject to review for compatibility with the Fourteenth Amendment’s Due Process Clause.”  BMS, 137 S. Ct. at 1779 (quoting Goodyear Dunlop Tires Operations, S.A. v. Brown, 564 U.S. 915, 918 (2011)).  “The Due Process Clause protects an individual’s liberty interest in not being subject to the binding judgments of a forum with which he has established no meaningful contacts, ties, or relations.” Burger King, 471 U.S. at 471-72.  The constitution “operates as a limitation on the jurisdiction of state courts to enter judgments affecting rights or interests of nonresident defendants.”  Kulko v. Superior Court, 436 U.S. 84, 91 (1978).  Restrictions on personal jurisdiction “are more than a guarantee of immunity from inconvenient or distant litigation.  They are a consequence of territorial limitations on the power of the respective States.”  Hanson v. Denckla, 357 U.S. 235, 251 (1958).  Given the interests at stake, even if there were no precedent, we think that Due Process considerations mandate that plaintiffs demonstrate that their assertion of personal jurisdiction over defendants is constitutional.

In any event, the peculiar burden of proof ruling in Hammons seems to us to cry out for additional review, which should begin with the en banc Superior Court being given the opportunity to sort out the discrepancies in that court’s panel decisions on this issue.

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

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

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

No – heat was.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Therefore,

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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