We’ve already provided two “reports from the front” about how the federal government is faring in False Claims Act cases where it has moved to dismiss actions over the objections of the relators supposedly pursuing recovery in the government’s name.  Here’s a third one, about Polansky v. Executive Health Resources, Inc., ___ F.4th ___, 2021 WL 4999092 (3d Cir. Oct. 28, 2021).  It’s the same basic fact pattern as the decisions discussed in our prior posts – the federal government, after declining to become involved, allowed a False Claims Act (“FCA”) relator to sue in its name for a while, but grew less and less enamored of the litigation, and ultimately moved, contrary to the wishes of the contingent fee relator, to dismiss the case with prejudice.  Here, the government so moved shortly after “the parties commenced discovery.”  Id. at *2.  That in itself is significant, since FCA relators are often free riders from a discovery standpoint, demanding big bucks, but with little information of their own, so the government, in the name of which the relator is suing, has to expend almost all of the discovery related time and effort.

Having provoked the government into seeking to dismiss his FCA action, the relator took the extreme position that once the government decided not to intervene, it could never thereafter seek to dismiss the action.  2021 WL 4999092, at *4.  That got nowhere.  Nothing in the FCA “suggests that the relator’s right to control the action is exclusive vis-a-vis the Government.”  Id. at *6.  Further:

had Congress intended so draconian a consequence as to strip the Government of all ability to terminate a case brought in its name, it would not have obscured it in a clause preserving the “status and rights of the [relator].”  Congress does not alter the fundamental details of a regulatory scheme in vague terms or ancillary provisions − it does not, one might say, hide elephants in mouseholes.

Id. (citations and quotation marks omitted).

Polansky saw fit to require the government to move to intervene before it could seek dismissal.  “[T]he Government must intervene before it can move to dismiss, but it can seek leave to intervene at any point in the litigation upon a showing of good cause.”  Id. at *5.  “Good cause,” Polansky held, “mean[s] simply a legally sufficient reason, and it is a standard the Government routinely satisfies.”  Id. at *7 (citation and quotation marks omitted).  Moreover, the intervention requirement seems mostly a formality, since Polansky went on to deem the government’s motion to dismiss as also constituting a motion to intervene:

Although the Government did not formally file such a[n intervention] motion before the District Court, that is no cause for remand on this record.  Instead, we construe the Government’s motion to dismiss as including a motion to intervene because intervention was in substance what the government sought and in form what the False Claims Act requires.

Id. at *11 (citation and quotation marks omitted).

On the merits, the Third Circuit declined to adopt either the position “giv[ing] the government an unfettered right to dismiss an action” or “the rational relation test . . . drawn from . . . substantive due process jurisprudence.”  Polansky, 2021 WL 4999092, at *10-11.  As discussed in our prior post, these are the positions taken by the District of Columbia, and the Ninth, Circuits, respectively.  Compare Swift v. United States, 318 F.3d 250, 252 (D.C. Cir. 2003), with United States ex rel. Sequoia Orange Co. v. Baird-Neece Packing Corp., 151 F.3d 1139, 1145 (9th Cir. 1998).  Instead, Polansky chose to complicate matters still further by adopting a third variant – judging the government’s dismissal motion against the standards of Fed. R. Civ. P. 41(a), governing voluntary dismissal.  Polansky, 2021 WL 4999092, at *8.  That means that, where, as in most cases, the government is seeking dismissal after the litigation has progressed, “dismissal must be only by court order, on terms the court considers proper.”  Id. at *9.

What the heck does that mean?

Polansky doesn’t really say.  Instead, the decision simply finds no abuse of discretion because:

The Court exhaustively examined the interests of the parties, their conduct over the course of the litigation, and the Government’s reasons for terminating the action.  It discussed, for instance, the litigation costs that [the] suit imposed on the Government, . . . [as well as] the prejudice to the non-governmental parties, concluding that, even though the litigation was at an advanced stage and significant resources had been expended on it by both the parties and the Court, there was little risk of prejudice. . . .  As for [the relator] , the District Court considered his argument . . . [and] also noted that [relator] had engaged in potentially sanctionable conduct during the course of discovery, and that this behavior was material and plays a role in the final disposition of this case.

Polansky, 2021 WL 4999092, at *11-12.  Thus, Polansky provides essentially no guidance to future courts faced with similar motions.  We do not know whether any of these actions are in fact required by the new Rule 41(a)-based standard – only that, since the district court did all that it did, dismissal was affirmed.

So while we can report that, once again, the government successfully obtained dismissal in Polansky we can’t tell you where, on the spectrum between Swift and Sequoia Orange, the Third Circuit falls, or even whether the Polansky is more, or less, deferential to the government’s position than the latter decision.

We have been following the issue of potential product liability for software, including in connection with medical devices, for a while.  Much of our attention, predictably, has been on FDA regulation of device software, including issues related to resistance to hacking to obtain information or cause harm.  Like here, here, here, and here.  We (well, Bexis and a colleague) have also taken a dive into the legal implications of the brave new world of 3D Printing.  As of that publication in 2017, there had not yet been any published decisions finding that software was a product for purposes of any state’s product liability law.  Id. at 163.  We have been surprised by the relative paucity of litigation over personal injuries against software manufacturers, social media companies, application developers, and manufacturers of various products that utilize software.  They get sued over alleged consumer economic injuries, business torts, contract disputes, and a range of anti-competitive behaviors all the time, but not that much over claims that defects in software resulted in physical injuries to actual people.  At least so far.

Given that we are just simple drug and device product liability lawyers, the issues in this post made us enlist an honest-to-goodness tech nerd lawyer, Gerry Stegmaier.  He deals with things like cybersecurity, privacy, the internet, and investigations for tech companies.  That makes this a hybrid (or perhaps cyborg) guest post with a modified disclaimer about responsibility and blame.  Not that we really think our disclaimers do much in the real world.

If science fiction has taught us anything, however, it is that technological advances can have unintended consequences.  That certainly goes for software.  HAL 9000 in 2001:  A Space Odyssey losing it on the crew – software.  Skynet in the Terminator movies achieving self-awareness, triggering a nuclear holocaust, and sending a cyborg back in time, only to have that cyborg get crushed by a hydraulic press and give humans the technology to create Skynet – software (and the time paradox).  Self-driving cars deciding who gets injured in no-win situations – software.  Asimov’s first law of robotics, that a robot may not injure a human being or, through inaction, allow a human being to come to harm – software.  Robots, of course, need to be programmed to do their thing.  More and more, as everything from vacuums to drones to automobiles seem to operate independent of contemporaneous human judgment and guidance, we will be increasingly faced with questions related to programming and the performance of that programming when tied to traditional products.

Marc Andreessen famously said, “software is eating the world.”  Unfortunately, much like litigation over obesity, the world will look to allocate responsibility for the effects of electronic over-eating.  Programming, at least in almost all of its current forms, reflects advanced human judgment and guidance as general intelligence in artificial intelligence does not yet exist, regardless of current industry hype cycles.  Increasing reliance on software and the programming it embodies may be scary to Luddites and anti-Luddites alike.  The role that humans play in the programming may assuage some, whereas others may despair at human fallibility (or our collective arrogance).  We cannot really spell that all out for everyone, but we do know that injuries happen and people sue over them.

In Holbrook v. Prodomax Automation Ltd., No. 1:17-cv-219, 2021 U.S. Dist. LEXIS 178325 (W.D. Mich. Sept. 20, 2021), we have what we think is the first decision to recognize software as a product for purposes of state product liability law.  It involves a death from an accident at an assembly line that used a bunch of robots and – as is almost always the case with product liability cases involving machinery—a plaintiff (here, an employee) who undisputedly failed to follow in-place safety policies.  Her estate sought to impose liability on a number of entities principally on the theory that the software that ran the robots was insufficient to protect her from her own irresponsible actions.  Owing to some quirks of Michigan law, it was the defendants that wanted the allegedly defective software to be considered a product.  That is the opposite of what we expect most software/programming companies would want when faced with potential liability for personal injuries.

Some Software Background

The software industry, despite occasional rhetoric suggesting it makes “products,” has much to lose and little to gain should the law surrounding intangibles be retooled.  Decisions that would habitually recognize and revisit the notion that software is not a product for purposes of product liability law will most certainly catch Silicon Valley and the rest of the software world by surprise.  Few software companies possess lawyers, much less product management teams, with any specific experience or familiarity with product liability law.  Where companies provide software for products, the software itself is almost never considered a component of the product nor is it or would it be “manufactured” using product-related standards.  In essence, the saying that if something does not have bugs it could not be software (which brings a smile to any software engineer’s face) has important implications if imported into product liability law.  Software is almost always intended to replace things that people used to do, whether that is driving, reading x-rays, or (as in Holbrook) operating an assembly line.  The law traditionally has judged what people do by a negligence standard of a “reasonable person” in the same position.  Product liability, however, imposes strict liability.  So to treat software as “products” runs the risk of replacing reasonableness with strict liability standards with respect to everything software does.  All of which brings us to the present case directly.

Holbrook’s Facts

The facts of the case are a bit complicated for those not versed in assembly line manufacturing, but we will to boil them to focus on the software liability issues for the two remaining defendants, one of which (Flex-N-Gate or “FNG”) was the parent company of the decedent’s employer and the other of which (Prodomax) designed, built, and installed the employer’s assembly line.  The companies that made the robots utilized in the assembly line had been dismissed.  FNG used the assembly line to make trailer hitch receiver assemblies for a certain brand of pickup trucks, and the decedent was employed as a maintenance technician.  To perform maintenance while the assembly line was operating, the decedent was supposed to press a button and wait for a green light before entering through a security door.  Pressing the button would turn off the robots in that area and raise the height of the safety walls around it, preventing other robots from entering the area.  She was also supposed to have locked the door to the area she was entering in an open position, which would also prevent robots from entering that area.

The decedent did none of those things.

Instead, on one day in 2015, the decedent climbed over a wall into a particular area to conduct some required maintenance.  With none of the safety measures activated, once she had addressed the maintenance issue, a robot from another section, performing as programmed, entered the zone and crushed her, after which other robots burned her (as programmed to weld parts together).  The injuries were fatal.  Shortly after the accident, the assembly line was re-programmed to power down all the robots when any zone door was opened.  Were the robots truly robots, in an Asimovian science fiction sense, they could have followed his first law, which would have precluded them (again, through programming) from harming any human.  But, this isn’t science fiction and that type of sentient self-awareness does not yet exist.  Nor does the programming to allow a machine to address the situation independently.  This reality is not at all new and remains one that philosophers, scholars and artificial intelligence and machine learning experts continue to ponder and tackle.  (Not the most august source, but this should give you some idea of what we mean here.)

Holbrook’s Analysis

Shortening the procedural history some, the decedent’s estate brought both common law negligence—which would have been the sole claim possible, had a non-programmed human run over the plaintiff with a forklift—and product liability claims based on the programming of the assembly line.  The court decided dueling summary judgment motions.

As readers will know from plenty of litigation over the years on the “FDA defense,” Michigan enacted a fairly defense-friendly Product Liability Statute in 1995.  One aspect of that statute is that all common law negligence claims are abrogated when the statute applies.  Id. at *11.  Certain statutory requirements and defenses led to the defendants wanting claims based on the programming of the assembly line to be considered “product liability” claims.  Under the Michigan statute, a product liability action seeks recovery under any theory for physical injuries “caused by or resulting from the production of a product.”  Id. at *12.  A product includes all of its component parts.  Id. at *14.  Production, in turn, is defined broadly as the “manufacture, construction, design, formulation, development of standards, preparation, processing, assembly, inspection, testing, listing, certifying, warning, instructing, marketing, selling, advertising, packaging, or labeling” of a product.  Id. at *13.  This broad definition tends to be helpful to manufacturers in Michigan.

Whether software/programming is a product under Michigan law had not been addressed by any court, so the Holbrook court’s analysis was on a clean Erie slate.  As noted above, relatively few cases anywhere have addressed this issue and those that have—without the broad definition from the Michigan statute—have found it is not.  (A recent opportunity for an appellate decision on this issue under California and/or Wisconsin law went away when the Ninth Circuit limited its decision in Lemmon v. Snap, Inc., 995 F.3d 1085 (9th Cir. 2021), to the issue of immunity under Section 230 the Communications Decency Act, which generally immunizes interactive computer service providers from liability for publishing another’s content.)  Those decisions have generally looked to definitions, as in both the second and third Restatements of Torts, of products as tangible things—that is, something that can be touched—whereas intangible things like software would be a service or rights to intellectual property.  With the facts here and the Michigan statutory definition, however, the court’s focus was on the programming as a “component” of the assembly line, which was clearly a product.  2021 U.S. Dist. LEXIS 178325, **15-16.

The PLC programming is an “integral” and “essential” part of the 100 line because, as [the estate] puts it, “without . . . the PLC program . . . the robotic components would not have been orchestrated to move at all within the line.”

Id. at **16-17 (citation omitted).  Thus, the challenge to the programming in terms of safety measures was a challenge to the design of a product for purposes of the MPLS—a challenge that in most states few software producers would like to confront.  Interestingly, although the court stated that the programming was “either a product itself or a component of the [assembly] line,” id. at *16, it never directly rules that the programming, alone, was a product.  Indeed, it emphasizes that the “programming need not qualify as a product itself.”  Id. at *17.

The estate offered a number of arguments to try to avoid abrogation.  It argued that programming was not part of the assembly line’s design because it occurred after the assembly line’s installation.  “That the programming was completed at the facility does not make it any less a part of the product’s design.”  Id.at *18.  It also argued that the definition of “product” in the Restatement (Third) of Torts § 19 as “tangible personal property distributed commercially for us of consumption” should be followed, but Michigan courts had not relied on this definition and the MPLS statutory definitions discussed above were broader than the definition in the Restatement or in the current Black’s Law Dictionary.  Id. at *19.  The estate also argued that the software here would be considered a service under the Uniform Commercial Code, but the “ultra-broad definition of ‘production’ in the MPLS means that the heavy bulk of Prodomax’s work in making the [assembly] line would qualify as a provision of goods rather than services.”  Id. at **19-20.  It also challenged the premise of abrogation, but that was a dead end.

With abrogation in place and with the estate’s agreement that FNG was not a manufacturer or seller under the MPLS, it was dismissed.

Prodomax could not rely on that distinction, so it argued that the decedent’s misuse—admitted by the estate—barred recovery under the MPLS.  It did not assert other defenses under the MPLS, including the one based on comment k—that the assembly line was unavoidably unsafe.  Under the MPLS, reasonably foreseeable misuse, an issue for the trial court to decide, is not a bar to recovery.  Here, the misuse was found to be foreseeable mostly because the security walls were easily climbed over when not raised.  Id.at *23.  It was insufficient that employees were trained on and expected to follow safety protocols, because “Prodomax anticipated improper wall-climbing and took measures, mainly through installing Vertiguard walls, to make such misuse more difficult.”  Id. at *24.  That’s one difference between strict liability, even of the statutory kind, and negligence.  Plaintiffs can recover despite acting unreasonably—while products must always perform safely.

Implications

While the defendants in Holbrook achieved their near term litigation objective, the longer term implications of the decision, or similar decisions, could have grave consequences for software development generally and for liability considerations related to any devices that are connected to the Internet or otherwise utilize software.  As a practical matter, this will increasingly implicate virtually all “smart” devices.  Software is generally regarded as being iterative (that is, involving repetitive actions), and one of the most distinctive features of Internet-enabled devices is their ability to not only continuously receive software updates but also to patch and otherwise repair existing software.  Thus, the introduction of strict liability via a determination that programming or software is a product could have profound implications.

Liability for defects in the design of software or how other products utilize software may not be terribly hard to prove in some cases.  Other situations, including alleged defects in open source software or machine learning, could be much more difficult to establish either what the defect was or who was responsible.

Unlike a prescription drug, for instance, software can and does get updated without running through lengthy studies and regulatory processes.  Like in Holbrook, the ability to make a change to address a safety issue relatively quickly and easily could be used against the software/programming companies in the context of risk/utility analysis.  Software providers probably will not have the learned intermediary (or sophisticated user) doctrine, comment k, or preemption as viable defenses.  In direct-to-consumer contexts, providers routinely seek to use contracts such as click-wrap licenses to allocate software-related liability including limitations on liability, forum selection clauses, compulsory arbitration and similar protective measures.  In the product liability context when personal injuries are at issue, we would not expect those clicks to be as meaningful as their authors might hope.  Overall, technology companies and similar organizations should closely monitor the Holbrook decision and others of its ilk.  Such groups might not ordinarily pay close attention to product liability law, but it would appear that product liability law may be on the cusp of paying closer attention to software development.

If drugs and medical devices undergo a product life cycle, so do drug and medical device litigations. We are currently laboring in the relatively early stage of a Multidistrict Litigation, where the court seems terrified of making any substantive decisions. We get no rulings. Rather, the parties are forced to listen to lectures about the need for everyone to work nicely together and, oh, while we’re at it, wouldn’t settlement be a grand idea? It is feckless judicial “management.”

By contrast, we are also in the mature stage of an MDL. There have been many inventory settlements, and the remaining cases have been remanded to judges who have little patience for bottom-feeders. Most remand cases are marked by sheer greed and craziness. There is little merit and judges are starting to … judge. We are seeing dismissals.

And we are thankful.

There are large numbers of pelvic mesh post-remand decisions these days that have been favorable for the defense. One cannot help but wonder why these cases could not have taken a ride in the ejection seat earlier. Thacker v. Ethicon, Inc., 2021 WL 5362076 (E.D.Kentucky Nov. 17, 2021), is particularly thoughtful – and favorable.

As is typical with these mesh cases, the plaintiff included every tort theory under the sun in her complaint. The defendant filed a motion for summary judgment on all claims and won across the board. As is also typical with these cases, the main action was with respect to failure to warn and design defect.

On warning, the defendant argued that the plaintiff had not mustered adequate evidence that a different warning would have made any difference. That is, there was a lack of warning causation. On this warning causation point, the Thacker decision goes through a number of causation-related bases for summary judgment (failure to read, not remembering reading, non-reliance, prior physician knowledge) before concluding that the implanting surgeon’s affirmative testimony on whether he would have done something differently was sufficiently strong that the plaintiff was obligated to come forward with some evidence to create an issue of fact. The plaintiff did not, so the court granted summary judgment on warnings.

Note that the Thacker court allowed that it might have arrived at a different result if there was a tabula rasa on warning causation. We do not agree with that. No evidence means no evidence and should mean no valid claim. A tie goes to the defendant. But the Thacker court says that a defendant first needs to come forward with evidence that a different warning would not have produced a different prescribing decision. Fine. We’ll deal with it. Consequently, the lesson for defendants is that, when in Kentucky, do not simply rest on absence of evidence of warning causation. Instead, the defense should ask questions of the treater to show absence of warning causation. In Thacker, the defense elicited from the treating physician that he believed the benefits of the mesh outweighed its risks, and he stood by his decision to use the mesh even with whatever additional information the plaintiff claimed should have been disclosed. Almost all treaters will give you that, so ask those questions at the deposition. If you get bad answers, don’t blame us. At least you’ll know you have a weak case. Alert settlement counsel. And give the case to someone else to take to trial. Surely, there is a young, eager lawyer down the hall hankering for trial experience. You can stay home and occasionally offer avuncular advice.

On design defect, most of the usual alternatives proposed by the usual plaintiff medical expert were not alternative products at all. Kentucky law turns out to be quite good on the need for a safer, feasible alternative product. The plaintiff’s expert (who shows up in many, many, many of these pelvic mesh cases and has made many, many, many dollars from this enterprise — $8 million at last count) suggested three other surgical procedures that did not use polypropylene mesh. Those were not alternative products; they were completely different altogether. They weren’t remotely in the same product category. It is like suggesting in a motorcycle accident case that the safer alternative was a car. Or walking.

The one product listed by the plaintiff expert that arguably could qualify as an alternative design under Kentucky law was a mesh that was lighter and contained less polypropylene. But the Thacker court held that the plaintiff did not establish a submissible case that such mesh was feasible. The plaintiff expert’s report was ipse dixit on that point, and the plaintiff didn’t offer anything else (another manifestation of the “don’t do anything” post-remand problem of the MDL plaintiff’s business model that we’ve discussed elsewhere). The Thacker court’s decision on this issue is important because it squarely holds that the expert’s mere say-so that the alternative was feasible and safer is not enough to fend off summary judgment.

There is a lengthy footnote discussing both sides of the FDA approval issue for alternative designs of FDA approved/cleared products. The plaintiff’s proposed safer alternative mesh had not been approved or cleared by the FDA for the indication at issue in the case. To our mind, that fact should render the product not feasible. The jury has no basis to speculate that a regulatory submission would have garnered positive action by the FDA. In any event, that issue did not drive the Thacker decision either pro or con. The Thacker court indicated that the effect of FDA silence probably turns on how a particular jurisdiction lays out the requirement of a safer, feasible alternative. But it didn’t matter in Thacker. With or without FDA approval/clearance, there simply was nothing of substance in the record to show feasibility or increased safety, so the Thacker court granted summary judgment on design defect as well.

The failure of the warning and design defect claims doomed the entire case. The various labels of the remaining causes of action, whether styled as negligence, strict liability, or anything else, were immaterial. Accordingly, the Thacker court dismissed the entire case case with prejudice.

Happy Thanksgiving. Save some spuds, cranberries, and a spot on the couch for us.

A couple of months ago we were sufficiently impressed by a guest post we received concerning Iowa and the learned intermediary rule.that we invited counsel familiar with the other states that lacked state-court appellate authority to give us their best pitch for the rule in those states.  We had volunteers for South Carolina and Wisconsin (Idaho, Maine, New Hampshire, North Dakota, Puerto Rico, Rhode Island, South Dakota, and Vermont are still available if anyone wants to volunteer).  Here’s the first one to be completed, South Carolina – authored by Jim Rogers, Joe Fornadel, and Shannon Coy, all of Nelson Mullins.  We thank them for stepping forward.  As always, our guest posters deserve 100% percent of the credit (and any blame) for what follows.

**********

Introduction

The current state of South Carolina law remains largely unchanged from the Blog’s 2007 coverage [ed. note the 2007 post is regularly updated]: it remains true that no South Carolina state appellate court has adopted the learned intermediary doctrine (“LID”) in a prescription medical product case against a product manufacturer.  There is an abundance of examples of federal courts taking their best Erie guess that the South Carolina Supreme Court would do so if presented squarely with the issue and some bread crumbs left by state court appellate decisions indicating the same.  Indeed, since 1984, the Fourth Circuit has held that the LID should be applied in the prescription product context under South Carolina law (with no contrary state precedent in the interim), making the issue largely academic for federal court practitioners.  Nevertheless, the LID has not crossed the goal line yet via a clear state appellate court decision, though there is little reason to believe that it will not at some point in the future.

History of the LID in South Carolina State Courts

The first South Carolina appellate court decision to mention the LID was Bragg v. Hi-Ranger, Inc.  There, the intermediate Court of Appeals considered the trial court’s instruction on the sophisticated user defense, which likened a sophisticated user to a “learned intermediary.”  462 S.E.2d 321, 331 (S.C. Ct. App. 1995).  Indeed, the current model jury charges contain this same language.  See Anderson, S.C. Requests to Charge – Civil, 32-8 (“Under South Carolina law, a manufacturer has no duty to warn of potential risks or dangers inherent in a product if the product is distributed to what we call a learned intermediary or distributed to a sophisticated user”).  Neither the Bragg decision nor the model charge go into any detail on the LID, but the recognition of the overlap between these doctrines is informative, particularly in the absence of any appellate caselaw expressly adopting the LID, let alone any declining to do so.

Almost a decade later, the South Carolina Supreme Court favorably discussed the LID in Madison v. American Home Prods. Corp., but the facts of the case did not put the issue squarely before the court.  595 S.E.2d 493, 494 (S.C. 2004).  There, the plaintiff ingested an anti-depressant and subsequently harmed her son and herself.  Following a criminal conviction related to the assault and battery of her son, the plaintiff sued both the drug manufacturer and the pharmacy that filled the prescription.  Ultimately, and for reasons not bearing further discussion here, the trial court never considered the substance of the claims against the manufacturer and there was no express appellate determination that the LID applied in this context.  Nevertheless, the pharmacy successfully sought dismissal of the claims stated against it.  In upholding this dismissal, the Supreme Court held that, among other things, “impos[ing] strict liability on pharmacists” was inappropriate, as “‘strict liability is inconsistent with the learned intermediary doctrine, which places the duty to warn on the prescribing physicians, and not pharmacists.’” Id. at 496 (citing David J. Marchitelli, Liability of Pharmacist Who Accurately Fills Prescription for Harm Resulting to User, 44 A.L.R. 5th 393, 419, § 2(a)(1996)).

In short, the South Carolina Supreme Court’s discussion of the LID in Madison is helpful and can be read as holding that the LID would apply in the context of a failure to warn claim stated against a prescription product manufacturer (as can the model charge regarding the sophisticated user defense).  A plaintiff may argue that the court set forth multiple grounds for affirming the grant of summary judgment for the pharmacy in Madison, thus making the LID endorsement mere dicta in an opinion that did not expressly address failure to warn claims directed at a manufacturer.  A defendant would call it an alternative holding.  Either way, this is a narrow objection to the LID, and potentially impossibly so, in light of the persuasive federal case law interpreting this doctrine.

Federal Courts & the LID
When Applying South Carolina Law

Though there may be some gap into which an enterprising state court plaintiff’s counsel could build an argument that the LID has not been recognized under South Carolina law, no such gap exists within the Fourth Circuit.  Federal courts have routinely reached the same conclusion when making their Erie guess as to whether the LID should apply in the prescription product context: it should.

In 1984, and predating Bragg by over a decade, the Fourth Circuit stated that, “[a]lthough the South Carolina Supreme Court has not addressed the issue, we conclude that it would expressly adopt the [LID], generally accepted and supported by sound policy, restricting the manufacturer’s duty to warn the prescribing physician.”  Brooks v. Medtronic, Inc., 750 F.2d 1227, 1231 (4th Cir. 1984).  Brooks involved a cardiac pacemaker and the Fourth Circuit held that the manufacturer of that prescription medical device had no duty to warn the patient of the risks associated with the device under the LID.  Id.

Since Brooks, the Fourth Circuit and the District Court for the District of South Carolina have applied the LID faithfully and repeatedly when interpreting South Carolina law.  See Bean v. Upsher-Smith Pharms., Inc., 765 F. App’x 934, 936 (4th Cir. 2019) (citing Brooks and affirming application of LID in context of prescription drugs), aff’g 2017 WL 4348330, at *7-*8 (D.S.C. Sept. 29, 2017); Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003 (4th Cir. 1992) (citing Brooks and applying the LID in prescription device context), aff’g No. D:90–0845–8, 1991 WL 11695212, at *1 (D.S.C. Dec. 11, 1991); McLeod v. Sandoz, Inc., No. 4:16-CV-01640-RBH, 2018 WL 1456739, at *3 (D.S.C. Mar. 23, 2018) (citing Odom and applying LID in prescription drug context); Harrison v. Davol, Inc., No. 8:17-1033-TMC, 2017 WL 10109447, at *3 (D.S.C. Nov. 8, 2017) (citing Brooks and Odom and applying the LID in the prescription device context); McLeod v. Sandoz, Inc., No. 4:16-CV-01640-RBH, 2017 WL 1196801, at *9-*10 (D.S.C. Mar. 31, 2017) (citing Brooks and Odom and applying LID in the prescription drug context); Luberda v. Purdue Frederick Corp., No. 4:13–cv–00897–RBH, 2014 WL 1315558, at *5 (D.S.C. Mar. 28, 2014) (citing Brooks and Odom and applying LID in the prescription drug context); Carnes v. Eli Lilly & Co., No. CA 0:13-591-CMC, 2013 WL 6622915, at *3 (D.S.C. Dec. 16, 2013) (citing Brooks and Odom and applying LID to prescription drugs); Sauls v. Wyeth Pharms., Inc., 846 F.Supp.2d 499, 502 (D.S.C. 2012) (citing Brooks and Odom and applying LID in prescription drug context); King v. Stryker Corp., No.  2:10-cv-3069-RMG, 2012 WL 12981763, at *5 (D.S.C. Apr. 3, 2012) (citing Brooks and applying LID in prescription device context); Fisher v. Pelstring, 817 F.Supp.2d 791, 811 (D.S.C. 2011) (citing Brooks and Odom and applying LID in prescription drug context); Jones v. Danek Med., Inc., No. 4:96–3323–12, 1999 WL 1133272, at *7 (D.S.C. Oct. 12, 1999) (citing Brooks and applying LID in prescription device context); see also Cribbs v. Beaufort Memorial Hosp., No. 9 05 415-PMD, 2005 WL 8166096, at *3 (D.S.C. Oct. 5, 2005) (in context of claims that hospital failed to warn of certain risks, holding that “‘virtually every jurisdiction considering the issue, including the Fourth Circuit, has concluded that the learned intermediary doctrine should apply not only to prescription drugs, but also to medical devices, which are prescribed or inserted by a physician’”) (quoting Pleasant v. Dow Corning Corp., No. 3:92–3180–17, 1993 WL 1156110, at *6 (D.S.C. Jan. 7, 1993) (citing Brooks)).

Indeed many federal court plaintiffs have not even disputed that the LID applies in the prescription product context.  E.g., Bean, 2017 WL 4348330, at *7–*8; Odom, 979 F.2d at 1003; McLeod, 2018 WL 1456739, at *3.  Some still choose to contest the issue, but the authors are not aware of any successful attempts in that regard.  Carnes, 2013 WL 6622915, at *4 (“Plaintiffs have not identified, and the court is unaware of, any decision from the South Carolina Supreme Court or Court of Appeals rejecting the learned intermediary doctrine in a prescription drug case”).

The most recent opinion from the Fourth Circuit on the issue, Bean, provides several interesting updates on the LID under South Carolina law (at least within the Fourth Circuit).  First, the Fourth Circuit read Madison as having “proven” the Fourth Circuit’s prediction in Brooks as “correct.”  765 F. App’x at 936.  This reading should foreclose any wiggle room potentially allowed by the fact that the Supreme Court was not squarely presented with a classic application of the LID in Madison.  Second, the Fourth Circuit also recognized that, even though the FDA requires direct-to-consumer warnings for some prescription products, this requirement does not impact to whom the manufacturer’s duty to warn runs for the purposes of a failure to warn claim.  Id. at 937.  The Fourth Circuit explained that to hold otherwise would contravene the FDA’s intent that the requirements for such direct-to-consumer warnings do not “alter the duty or set the standard of care for manufacturers.”  Id. (quoting 63 Fed. Reg. 66378, 66384 (Dec. 1, 1998)).

Looking beyond the Fourth Circuit, the Texas Supreme Court included South Carolina among the “highest courts of at least thirty-five states [that] have adopted some form of the [LID]” on the strength of MadisonCentocor, Inc. v. Hamilton, 372 S.W.3d 140, 173 n.17 (Tex. 2012).  Federal courts applying South Carolina law in other jurisdictions also have found that South Carolina follows the LID.  See Nodine v. Shiley Inc., No. SA CV 97-431-GLT EEX, 1999 WL 1487423, at *2 (C.D. Cal. Jan. 28, 1999) (involving application of the LID in the context of a fraud claim against the manufacturer of an artificial heart valve), aff’d, 240 F.3d 1149 (9th Cir. 2001) (affirmed on statute of limitations grounds without discussion of the substantive claim); Purnell v. United States, No. CIV.A. 86-4475, 1987 WL 11212, at *1 (E.D. Pa. May 21, 1987) (citing Brooks and applying LID in prescription drug context).  Additionally, the District Court for the Eastern District of Texas listed South Carolina in a table of forty-eight jurisdictions that either apply or recognize the LID without exception to prescription drugs.  See In re Norplant Contraceptive Prod. Liab. Litig., 215 F. Supp. 2d 795, 806 (E.D. Tex. 2002) (citing Brooks and Odom).

Thus, it is settled that, at least in federal courts, the LID should be applied when analyzing South Carolina law.  This nearly 30-year body of caselaw should be persuasive, though admittedly not binding, on any state court presented with the issue.

Conclusion

As reported on the Blog back in 2007 [ed. note the 2007 post is regularly updated], the issue of whether the LID applies under South Carolina law remains on the goal line.  The South Carolina Supreme Court’s holding in Madison implies that the LID is viable and, indeed, in the eyes of the Fourth Circuit, this opinion was enough to push the issue over the goal line.  Bean, 765 F. App’x at 936.  Further, a review of the remaining published opinions involving the LID reveals no reason to suspect that the LID would not be adopted.  More broadly, most jurisdictions have adopted the LID at this point and the latest Restatement section regarding the same recognizes as much.  Restatement (Third) of Torts: Prods. Liab. § 6, cmt. b (Am. Law. Inst. 1998) (“The obligation of a manufacturer to warn about risks attendant to the use of drugs and medical devices that may be sold only pursuant to a health-care provider’s prescription traditionally has required warnings directed to health-care providers and not to patients”) (emphasis added).  There is little reason to believe the South Carolina Supreme Court will not cross the goal line at the first opportunity to do so, but, until then, the issue remains unsettled in South Carolina state courts.

Some product liability cases are so bad they won’t fly even in California.  Gall v. Smith & Nephew, Inc., ___ Cal. Rptr.3d ___, 2021 WL 5027197 (Cal. App. Oct. 29, 2021), is one of those.  Plaintiff alleged that the defendant inadequately warned about the alleged risks of a hip implant, or alternatively that the device was defective in some other way, although “how” was never quite clear.  The trial court held that plaintiff “did not show anything was wrong with his implant,” id. at *1, and on appeal the court of appeal affirmed.

One thing California law has always been pretty good on is the learned intermediary rule.  As explained in Gall:

[F]or prescription drugs and implants, the doctor interrupts the ordinary commercial chain from the manufacturer to the final consumer.  Patients want to be able to rely entirely on their doctors’ informed and independent judgments.  The law and medical ethics both demand that doctors, for their patients’ benefit, evaluate scientific information about prescription drugs and implants.  Manufacturers thus must warn doctors about product risks. This duty does not extend to patients.

Id. at *3 (emphasis original).  Thus, the “decisive issue” was “what medical risks [the surgeon] knew” when he met with the plaintiff – “what [he] told [plaintiff] is a different matter.”  Id. (emphasis original).  When a prescribing physician is already “fully informed” about product risks, causation fails in a warning case because the physician “already had the needed warning.”  Id.

This surgeon knew a lot.

[His] deposition was unambiguous.  [The surgeon] knew about the metal ion issue because he read the underlying scientific studies as they appeared.  [He] used primary materials to keep himself current in his specialty and did not need or use manufacturers’ republications and warnings.

Id.  The surgeon “was clear and consistent throughout his deposition: he knew about this risk.”  Id.  Plaintiff’s attempt to seize on a single confused testimonial exchange punctuated by an objection from the surgeon’s counsel galled the court.  Plaintiff’s “proposed interpretation is not reasonable.  [The surgeon] testified he did know of the ion risk on [the relevant date].  [That] testimony was straightforward: steadfast, unequivocal, and with no backtracking.”  Id.

The learned intermediary’s indisputable knowledge of the relevant risks “deflate[d]” the plaintiff’s other arguments.  Purported “delay in getting data to the [FDA]” didn’t matter a hill of beans since the prescribing surgeon “knew of the . . . risk when counseling [plaintiff].”  Id. at *4.  These “secondhand reports were superfluous.”  Id.  For the same reason, neither did some foreign “agency alert” or “an allegedly deficient brochure.”  Id.  Those “merely repeated what [the surgeon] already knew.”  Id.  Addition of an FDA logo to previously known information changed nothing.  Gall found no “authority for the notion that an agency imprimatur changes the quality or significance of the science the agency relayed.”  Id.  Summary judgment on warnings affirmed.

Plaintiff’s other theory was called “manufacturing defect.”  Id.  In California, that requires the product to “differ[] either from what the manufacturer intended or from the standard items in the manufacturer’s same product line.”  Id. (citation omitted).  What gall!  Here the evidence was “contrary” to such a theory, showing instead two pre-implantation inspections of the product – one at the factory and one by the surgeon himself.  “Both inspections showed [plaintiff’s] implant was free of defects.”  Id.

Plaintiff relied on what sounds like an FDA inspection Form 483 that noted a “lack[ of] validation of supplier processes.”  Id.  Gall recognized that this was a load of gall – FDA process violations do not equate with defective products under California law:

[T]his report . . . show[ed] merely that [defendant’s] quality control process did not satisfy the regulatory authorities.  No evidence shows any defective product entered the stream of commerce.  [Plaintiff] cites no product defect precedent for substituting a process defect for a product defect.

2021 WL 5027197, at *4 (emphasis original).  Gall rejected this “proposed doctrinal innovation.”  Id.  Summary judgment affirmed on manufacturing defect.

Going forward, this point is the most significant part of the Gall decision.  Plaintiffs attempt this kind of claim all the time – asserting that claims that defendants failed to adhere to every jot and tittle of FDA-mandated GMP processes somehow equates to state-law product defects.  Gall is binding authority that, in California anyway, such manufacturing process violations do not translate to state-law torts.  Gall did not involve a Class III pre-market approved device, but its recognition of the inherent disconnect between FDA “processes” and California common-law “product defects”  should result in preemption of similar Class III claims.  To qualify as “parallel” claims, alleged FDCA violations must be genuinely equivalent to existing state-law product defects.  Gall holds that FDA-related “process defects” simply aren’t.

Two more points.  Gall also holds:  (1) a plaintiff’s injury cannot be evidence of a defect where the same injury is also a “risk[] of nondefective” products; and (2) negligence claims fail along with their strict liability analogs because they “share the same causation element.”  Id.

Finally, plaintiff had the gall to argue that summary judgment was erroneous because the affidavit attached to the winning motion was executed “outside California but did not include language stating [the affiant] made the declaration under penalty of perjury ‘under the laws of the State of California.’”  Id.  That mistake was corrected when first brought up.  Id.  To assert it on appeal was “meritless.”  Id.

Now that a childhood COVID-19 vaccine has received FDA approval, the vaccination of school-aged minors is underway.  Just as vaccination requirements for adults have prompted a wave of litigation, we expect the same with respect to COVID-19 vaccination as a prerequisite to attending primary schools.  But with a twist.  Unlike adults who ignore mandatory public health measures, parents are subject to a general common-law duty of care to “control” their minor children.  See Restatement (Second) of Torts §316 (1965) (“A parent is under a duty to exercise reasonable care so to control his minor child as to prevent it from intentionally harming others or from so conducting itself as to create an unreasonable risk of bodily harm to them.”).

Most of the §316 cases we’ve seen (we haven’t looked that hard) involve minor children misusing guns.  E.g., K.H. v. J.R., 826 A.2d 863, 873 (Pa. 2003) (“Although a parent/child relationship by itself is insufficient to render the parents liable for the tortious acts of their children, liability may attach where the negligence of the parents makes the injury possible.”) (misuse of BB gun) (citing, inter alia Restatement Second §316); Robertson v. Wentz, 232 Cal. Rptr. 634, 637-39 (Cal. App. 1986) (§316 firearms case dismissed where parental ability to control not established).

We haven’t seen any vaccination-related court decisions yet, but the scholarly literature discusses situations where one parent might sue another parent over the defendant parent’s sending an unvaccinated kid to school, and allegedly causing the plaintiff parent’s child to become infected.  See Kevin Hooker, “Exemptions to Vaccine Mandates:  The Problem & Possible Remedies,” 14 Hous. J. Health L. & Pol’y 263 (2014); Teri Baxter, “Tort Liability for Parents Who Choose Not to Vaccinate Their Children & Whose Unvaccinated Children Infect Others,” 82 U. Cin. L. Rev. 103 (2013); Dorit Reiss, “Compensating the Victims of Failure to Vaccinate:  What are the Options?” 23 Cornell J. L. & Pub. Pol’y 595 (2013).  The range of possible fact patterns could range from simply knowingly sending an unvaccinated child to school, to sending an unvaccinated child to school when either the child or the parents are known or suspected of having COVID-19, claiming some other bogus form of immunization, to lying about vaccination status to school authorities, all the way up to sending an unvaccinated child to school with forged vaccination papers.  As the links indicate, press reports discussing variants of all of these situations already exist.  Further, where a child is sent to school in violation of a mandatory COVID vaccination requirement, if and when such requirements exist (as they have for decades with respect to vaccination against other diseases), a negligence per se claim might be alleged, in addition to common-law negligence under §316.

However, administration of COVID-19 vaccine (or masking, for that matter) is a classic “covered countermeasure” under the PREP Act, 42 U.S.C. §247d(i)(1).  That led us to wonder whether antivax parents, if sued by other parents for their children infecting the plaintiffs’ children with COVID-19 at school, could claim immunity from suit under the PREP Act.  That would depend on whether parents who chose to withhold a “covered countermeasure” from their own children are “covered persons” under 42 U.S.C. §247d(i)(2).  So, who is a covered person?  The PREP Act provides:

The term “covered person”, when used with respect to the administration or use of a covered countermeasure [such as COVID-19 vaccination or masking], means −

(A) the United States; or

(B) a person or entity that is—

(i) a manufacturer of such countermeasure;

(ii) a distributor of such countermeasure;

(iii) a program planner of such countermeasure;

(iv) a qualified person who prescribed, administered, or dispensed such countermeasure; or

(v) an official, agent, or employee of a person or entity described in clause (i), (ii), (iii), or (iv).

Id.

Antivax parents are obviously not the government, or manufacturers, distributors or dispensers of COVID-19 vaccines.  That leaves immunity as a “program planner” on the table.  Parents certainly plan, and are responsible for, the vaccination – or not – of their children.  Indeed, in preparing our Survival of the Vaxxest post we ran across a couple of cases in which failure to vaccinate was a basis for termination of parental rights.  See In re Marsh, 14 A.2d 368, 370 (Pa. Super. 1940); Matter of Christine M., 595 N.Y.S.2d 606, 618 (N.Y. Fam. Ct. Dec. 21, 1992).  So could antivax parents claim PREP Act immunity from suits for damages for their unvaccinated kids infecting their schoolmates?

We turn to the Act’s definition of “program planner”:

The term “program planner” means a State or local government, including an Indian tribe, a person employed by the State or local government, or other person who supervised or administered a program with respect to the administration, dispensing, distribution, provision, or use of a security countermeasure or a qualified pandemic or epidemic product, including a person who has established requirements, provided policy guidance, or supplied technical or scientific advice or assistance or provides a facility to administer or use a covered countermeasure in accordance with a declaration under subsection (b).

42 U.S.C. §247d(i)(6).  The “other person” language of this definition, applicable to a private individual, such as a parent, requires supervision or administration of a “program” that involves “administration, dispensing, distribution, provision, or use” of a “pandemic . . . product” (such as a vaccine or a mask).  That can include someone who “has established requirements, provided policy guidance, or supplied technical or scientific advice or assistance” to such a program.  Id.

That would not seem to include an antivax parent, although without the PREP Act defining “program” we can’t be sure – we’ve seen plenty of ridiculous claims in COVID-19-related litigation already, so an antivax parent might claim to be “establish[ing] requirements” for his or her child’s vaccination, or even to have provided “advice or assistance,” although we doubt that is what the HHS had in mind when it made its PREP Act emergency declaration:

A program planner means a state or local government . . .; a person employed by the state or local government; or other person who supervises or administers a program with respect to the administration, dispensing, distribution, provision, or use of a Covered Countermeasure, including a person who establishes requirements, provides policy guidance, or supplies technical or scientific advice or assistance or provides a facility to administer or use a Covered Countermeasure in accordance with the Secretary’s Declaration.  Under this definition, a private sector employer or community group or other “person” can be a program planner when it carries out the described activities.

85 Fed. Reg. 15198, 15199 (HHS March 17, 2020).  Nor have any of the subsequent amendments to the initial declaration addressed parental actions.

Recent PREP Act caselaw provides another wrinkle.  In COVID-19 cases – mostly involving nursing homes – courts have drawn a distinction between the alleged “failure” of “program administrators” to employ COVID countermeasures and the alleged negligent employment of such countermeasures.  Courts have allowed the first category, claims of nonfeasance, to proceed notwithstanding PREP Act immunity.

[T]he complaints do not allege that Plaintiffs’ injuries arose from . . . administration to them of vaccines or medicines (or for that matter protective gear) − activities that the PREP Act promotes by affording immunity. . . .  Plaintiffs are claiming (inter alia) that the Defendants committed negligence in that, among other things, they failed to take countermeasures, some of them allegedly federally required.

Estate of Maglioli v. Andover Subacute Rehabilitation Center I, 478 F. Supp.3d 518, 532 (D.N.J. 2020), aff’d on other grounds, ___ F.4th ___, 2021 WL 4890189 (3d Cir. Oct. 20, 2021).  See also Lutz v. Big Blue Healthcare, Inc., 480 F. Supp.3d 1207, 1216-17 (D. Kan. 2020); Gunter v. CCRC OPCO-Freedom Square, LLC, 2020 WL 8461513, at *4 (M.D. Fla. Oct. 29, 2020); Sherod v. Comprehensive Healthcare Management Services, LLC, 2020 WL 6140474, at *7-8 (W.D. Pa. Oct. 16, 2020); Estate of Jones v. St. Jude Operating Co., LLC, 2020 WL 8361924, at *9 (D. Or. Oct. 14, 2020); Martin v. Serrano Post Acute LLC, 2020 WL 5422949, at *2 (C.D. Cal. Sept. 10, 2020).

These situations are essentially the same as allegations that would be asserted against antivax parents whose children allegedly infected a plaintiff’s child with COVID-29 – the defendants didn’t do anything, rather they failed to do something, that being vaccinating (or masking) their children.  Thus it is likely that, in any COVID-19-related litigation against a defendant for failure to vaccinate their children before sending them to school, courts would consider the alleged conduct to be nonfeasance that would escape PREP Act immunity under the above case law.

Finally, there is an express statutory exception to PREP Act immunity for persons who committed “willful misconduct,” which is defined as actions or omissions committed:

(i) intentionally to achieve a wrongful purpose;

(ii) knowingly without legal or factual justification; and

(iii) in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.

42 U.S.C. §247d(c)(1)(A).  See Maglioli v. Alliance HC Holdings LLC, ___ F.4th ___, 2021 WL 4890189, at *2 (3d Cir. Oct. 20, 2021) (discussing this exception).  Some of the more aggravated fact patterns we mentioned above – forgery of vaccination documents, affirmatively lying about immunization status, or knowingly sending a COVID-19 positive child to school – might well fit within the PREP Act’s definition of “wilfull misconduct” and allow litigation to proceed on that basis.

Federal law regulates medical devices differently from pharmaceuticals, and branded drugs differently from generic drugs. Whether a particular state-law tort claim is preempted often depends on whether the claim involves a medical device, a branded drug, or a generic drug. Often but not always. As today’s case illustrates, there is one implied-preemption principle that applies to medical devices, branded drugs, and generic drugs equally.

Medford v. Eon Labs, 2021 WL 5204035 (D.N.J. 2021), involved failure-to-warn and consumer-protection claims brought against generic drug manufacturers, specifically, manufacturers of Amiodarone, a generic version of Cordarone, which is used to treat irregular heartbeats.

The plaintiffs alleged that they or they decedents were injured when they were prescribed Amiodarone for treatment of atrial fibrillation. According to the plaintiffs, using Amiodarone to treat atrial fibrillation is an off-label use of the drug, whose FDA-approved label purportedly states that the drug is indicated for treatment of ventricular fibrillation and ventricular tachycardia.

The plaintiffs’ state-law claims rested on the contention that the generic drug manufacturers: 1. failed to distribute federally required Medication Guides; 2. promoted off-label use of Amiodarone; 3. failed to warn of the risks supposedly associated with off-label use of the drug; and 4. failed to submit adverse-event reports to the FDA.

The court held that the plaintiffs’ claims were impliedly preempted by federal law. The court relied—albeit indirectly—on 21 U.S.C. § 337(a) as authoritatively interpreted in Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001). Section 337(a) declares that all actions to enforce the Food, Drug, and Cosmetic Act “shall be by and in the name of the United States.” This, said Buckman, “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance” with the FDCA. Id. at 349 n.4.” That the Medford court relied on Buckman, a device case, in a generic-drug case underscores the fact that § 337(a), the no-private-right-of-action provision, applies equally to all products regulated under the FDCA.

Plaintiffs’ claims were impliedly preempted by § 337(a) insofar as they rested on the manufacturers alleged failure to distribute Medication Guides because, said the court, their complaint did “not identify any state law requiring generic manufacturers to provide a Medication Guide.” 2021 WL 5204035, at *4. “[T]o the contrary,” their complaint “repeatedly reference[d] the FDA regulations on Medication Guides” as the basis for the manufacturers’ purported tort duty. Id. Thus, although the plaintiffs “couch[ed] their failure to warn claims in traditional state tort law, … the gravamen of these claims” was the defendants’ purported violation of “the FDA’s medication guide regulation.” Id. That, the court correctly concluded, is not allowed under Buckman, which held that § 337(a) impliedly preempts all “state law claims that ‘“exist solely by virtue of the FDCA … requirements.”’” Id. (quoting Frei v. Taro Pharms. U.S.A., Inc., 443 F. Supp. 3d 456, 468 (S.D.N.Y. 2020), in turn quoting Buckman, 531 U.S. at 352).

Plaintiffs’ claims were also held impliedly preempted under Buckman insofar as they rested on the manufacturers’ purported promotion of Amiodarone for off-label use. The court explained that because there is no “applicable state law that parallels the FDCA’s” purported prohibition on off-label promotion, the plaintiffs’ off-label promotion claims “rest[ed] solely on federal law.” 2021 WL 5204035, at *4.

The same was true, the court said, insofar as the plaintiffs’ claims rested on the manufacturers’ alleged failure to file adverse-event reports with the FDA because “‘New Jersey is a jurisdiction that “declin[es] to recognize a separate state law duty to warn the FDA.”’” 2021 WL 5204035, at *4.

Notice that everything the court held would be equally true if analogous claims had been asserted against device manufacturers or branded-drug manufacturers. Nothing turns on the fact that a generic drug was at issue. Section 337(a) prohibits all private actions to enforce any provision of the FDCA, regardless of the product in question.

But, as noted at the outset, preemption does often depend on the product at issue. In Medford, the plaintiff’s claim that the generic-drug manufacturers were liable because they had failed to revise their labeling to warn of the risks supposedly associated with off-label use of Amiodarone was impliedly preempted under PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), because generic-drug manufacturers are unable to unilaterally change their warning labels, even in response to newly acquired information. The result might have been different under Wyeth v. Levine, 555 U.S. 555 (2009), had the drug in question been a branded drug because FDA regulations allow brandname manufacturers to unilaterally change their labeling under certain circumstances. If the product at issue were a medical device with premarket approval, the claim would not be impliedly preempted because device manufacturers also may unilaterally revise their labels under certain circumstances. But although not impliedly preempted if asserted in connection with a medical device, the claim would nonetheless be expressly preempted under 21 U.S.C. § 360k(a) because—as held in National Meat Association v. Harris, 565 U.S. 452 (2012)—state law may not require that which federal allow merely allows when federal law prohibits state requirements different from or in addition to federal requirements.

So, beware the differences between medical devices, branded drugs, and generic drugs, but also remember that 21 U.S.C. § 337(a) applies to each.

Judge Burroughs up in Boston recently wrote a clear and correct opinion regarding corporate citizenship, principal place of business, personal jurisdiction, and jurisdictional discovery. She was short and to the point, and we will try to be so as well.

The case is Lopez v. Angiodynamics, Inc., 2021 U.S. Dist. LEXIS 208161 (D. Mass. Oct. 28, 2021). It is one of a number of similar cases, all involving the same defendant, all of which may be found on our current personal jurisdiction cheat sheet.  The plaintiff claimed injuries from a vascular access port device. She filed her complaint against two related companies in Massachusetts state court. The defendants removed the case to federal court on grounds of federal diversity jurisdiction. The plaintiff then filed a motion for remand, arguing that the defendants were Massachusetts citizens and, therefore, removal was prohibited by the forum defendant rule. The issue was whether the manufacturer defendants were citizens of Massachusetts or somewhere else.

The defendants were incorporated in Delaware. Thus, the specific issue was where their principal places of business were located. The Lopez court applied the nerve center test and concluded that both defendants’ principal places of business were in New York. According to a CFO’s affidavit, that is where their operations were carried out, where the C-suites were, where the accounting, legal, and human resources departments were, and where all significant corporate decisions were made. The plaintiff advanced some evidence of Massachusetts activities by the defendants, but similar evidence had failed in prior similar cases and also failed here. The case would stay in federal court.

Next on the menu was whether the plaintiff could carry the burden of establishing that personal jurisdiction existed over the defendants. Because the defendants were not citizens of Massachusetts, general personal jurisdiction was out of the question under Bauman. The court’s inquiry under both the Massachusetts long arm statute and the U.S. Constitution was whether the defendants’ business activities in Massachusetts (including some research, development, marketing, and regulatory activities) were connected to the plaintiffs’ injuries. They weren’t. There was no link between whatever the defendants did in the Bay State with the medical device at issue (which was manufactured in New York).

Meanwhile, the plaintiff lived in Texas, was implanted with the device in Texas, and was allegedly injured in Texas, and was treated in Texas. Why was the case filed in Massachusetts? Were the plaintiff lawyers Red Sox fans? Did they crave lobster rolls? Were they fans of Emerson, Thoreau, Julia Child, Uma Thurman, John Krasinski, Larry Bird, and Bill Burr? Was a visit to the Norman Rockwell Museum on their bucket list? No matter. There was “no perceptible connection between the work that Defendants do in Massachusetts and Mr. Lopez’s claims.” Consequently, there was no specific personal jurisdiction over the defendants in this case.

The plaintiff also threw a Doug Flutie-esque Hail Mary pass and argued that because the defendants had been served with process in Massachusetts, that fact alone made them subject to personal jurisdiction there. That argument is not wicked smart and would, as the Lopez court pointed out, render SCOTUS precedent on personal jurisdiction a nullity.

Finally, the plaintiff sought leave to conduct jurisdictional discovery. As the great Boston rock group Aerosmith sang, “Dream On.” Because the plaintiff failed to make out “a colorable case for the existence of personal jurisdiction,” the Lopez court declined to exercise its discretion to grant jurisdictional discovery. The court dismissed the complaint with prejudice.

In one of their early hits, The Bee Gees sang, “I will be back to Massachusetts.” Not so for the Lopez case.

In general, people do not like to have to repeat themselves.  It is unavoidable.  Sometimes your audience is rightfully (or wrongfully) distracted.  Sometimes you aren’t that clear.  Sometimes you lose your zoom audio connection and have to start over.  Sometimes you don’t notice your daughter’s earbuds are in and that she’s been watching a YouTube video instead of hearing anything you just said.  It happens.  But a judge’s written opinion telling you everything you failed to do to state your case is not the same as trying to be heard across a table in a loud restaurant.  So, we think judges probably fall into the category of people who really, really do not like to have to repeat themselves.  It is a waste of time, effort, and resources.  So, when a court’s decision on a second motion to dismiss starts with “[t]he allegations in the Second Amended Complaint are the same as in the First Amended Complaint” except now plaintiff alleges more devices caused his injuries” – forced repetition follows.  Vicente v. DePuy Synthes Companies, 2021 WL 5150196, *2 (D.N.J. Nov. 5, 2021).

For context, plaintiff was in a motorcycle accident that caused several fractures in his left leg.  The surgical repair of his injuries included the implantation of orthopedic screws and plates.  Plaintiff required multiple subsequent surgeries for various reasons, including for hardware failure.  Id. at *1.  He sued the hardware manufacturer for strict liability design, manufacturing and warning defects and breach of express and implied warranty.  Id. at *2.   We posted about the court’s first dismissal of this case at the end of last year.  Based on a requested extension of time, plaintiff did not file his Second Amended Complaint until August of this year.  Id. at *3.  He had seven months to fix the pleading deficiencies pointed out by the court and instead decided to make the court do the whole thing all over again.

First the court had to re-dismiss plaintiff’s implied warranty claim because it is subsumed by the New Jersey Products Liability Act (“NJPLA”).  All claims for harm caused by a product in New Jersey fall under the NJPLA except for breach of express warranty.  Id. at *4.  Nothing in plaintiff’s allegations changed the court’s thinking.  Plaintiff’s implied warranty claim was based on an allegation defendant impliedly warranted the device was safe but breached that warranty because the device’s design was flawed.  Id. But that was just plaintiff’s attempt to “disguise[e] what would traditionally be considered a products liability claim as an alternative cause of action.”  Id. at *5.  Basing a breach of warranty claim on an alleged design defect is a just a “re-packaged design defect claim.”

Next the court moved onto the express warranty claim which failed the first time for lack of any factual assertions regarding what plaintiff or his doctors allegedly relied upon.  True too for this go round.  Plaintiff’s second amended complaint failed to allege what descriptions or statements were made to plaintiff to form the basis of any bargain, what plaintiff relied on before undergoing surgery with defendant’s devices, and how any particular product failed to conform to defendant’s description.  Id. at *6.

To state a claim for design defect in New Jersey, plaintiff must allege either a feasible safer alternative design or that the product’s risk outweighs its utility.  Id. at *6.  Plaintiff failed to allege either, instead arguing – again — that he should be able to rely on the consumer expectations test.  But that is only available in New Jersey when it is “self-evident” the product is not reasonably safe and fails to perform as a reasonable consumer would expect.  Id. at *7.   Medical devices are complex and a question like how long an orthopedic screw can last in the presence of an unhealed fracture is not something within the general knowledge of the average consumer or lay person.  Id.  Nor is an allegation that the device broke sufficient evidence of a design defect.  “[T]he design standard is not one of perfection, but reasonableness . . . [i]t is not enough to allege that an injury should not have happened.”  Id.

Nor is the mere happening of an accident, such as a device breaking, sufficient to plead a manufacturing defect claim.  Id. at *8.  In its decision on the first motion to dismiss, the court told plaintiff he was missing factual allegations about the supposed manufacturing defects.  Seven months later the same is true.  Plaintiff still did not allege some deviation from the intended design.  Attempting to rely on a malfunction theory, plaintiff argued the severity, type, and timing of his injuries were enough to “suggest” that something went wrong.  Id. at *9.  But because broken devices can occur in the absence of a defect – meaning plaintiff’s injuries could be the result of other causes – he could not proceed on circumstantial evidence.  Id.

Finally, the court re-examined plaintiff’s identically re-pleaded failure to warn allegations which amounted to nothing more than that defendant knew or should have known of the risk of device failure and the need for revision surgery.  And which the court again found conclusory and insufficient to satisfy TwIqbalId.  But that wasn’t the only thing plaintiff failed to remedy.  Plaintiff’s failure to warn claim also failed under the learned intermediary doctrine to which New Jersey recognizes a direct-to-consumer advertising exception.  But plaintiff failed to allege any DTC advertising to get him around the learned intermediary doctrine.  Last, but not least, the NJPLA has a presumption of adequacy for warnings the FDA finds adequate.  Plaintiff failed to plead any facts to counter that presumption.  Id. at *10.

About the only thing new this time around is that the court dismissed plaintiff’s claims with prejudice.  After seven months, “the differences [or lack thereof] between the First and Second Amended complaints do not suggest that the plaintiff is progressing in the direction of an actionable claim.”  Id.

The DDL blog (again) offers a tip of the cyber hat to Terry Henry at Blank Rome for sending the Vicente case to us.

LinkedIn has become one of the preferred ways of corporate communication.  Our own firm encourages us to maintain LinkedIn profiles and use them as a way of networking with clients and potential clients.  That’s all well and good.  But as with all public social media platforms, users – particularly corporate users – need to be careful to make sure that what is said is accurate, and not overblown.  Remember that not just us, but lawyers for the other side, also use LinkedIn.  Two recent cases piqued our interest in this topic.

In National Union Fire Insurance Co. v. Estate of Calendine, 2021 WL 4521901 (D. Colo. Oct. 4, 2021), the plaintiff asserted the defendant’s citizenship “on information and belief.”  Taking that “to mean that plaintiff did not have affirmative knowledge of any of these defendants’ citizenship,” the court sua sponte questioned the basis for subject matter jurisdiction.  Id. at *1.  The plaintiff went to LinkedIn and attempted to use information from the defendant’s employees’ profiles against it.  This attempt was unsuccessful because “[t]he allegations that plaintiff works in [the state] are based on screenshots from an unverified LinkedIn profile, which also do not establish intent to remain in [the state].”  Id.  The court cited two other decisions likewise “finding screenshots from Linkedin profile insufficient to establish citizenship.”  Id. (citing Keita v. Barlow, 2021 WL 1748027, at *1 (D. Colo. May 3, 2021), and McLaughlin Group, Inc. v. Vac-Tron Holdings, Inc., 2020 WL 7640870, at *1 (D. Colo. Dec. 23, 2020)).  Score one for the defense.

A day later, Zuzel v. Cardinal Health, Inc., 2021 WL 4552284 (E.D. Pa. Oct. 5, 2021), reached a somewhat conflicting result, relying on information from a LinkedIn profile to deny summary judgment to a defendant claiming not to be a “seller” of a product.  The plaintiff pointed to the profile of an employee – questioning whether he worked for the defendant parent company, or a subsidiary.  Id. at *5.  The defendant rebutted with an affidavit from the employee “reaffirming that he is employed by [the subsidiary], not [the parent], and explaining that his LinkedIn profile lists [the parent] ‘for ease of reference and for networking purposes because [the subsidiary] is not a readily-recognizable entity.’”  Id.  Zuzel, however, found an issue of fact:

Plaintiff argues that the discrepancy between [the employee’s] interrogatory verification and LinkedIn profile, on the one hand, and his affidavit on the other, raises questions concerning his credibility . . . .  The Court agrees that [the employee’s] previous statements indicating his affiliation with [the parent] raise questions about the credibility of his assertion that [the subsidiary] and [the parent] operated separately, including with their own employees.

Id. at *5-6 (citation omitted).  Score one for the plaintiffs.

Hence, this take-home – when corporate separation matters, it also matters for corporate employees to be accurate on LinkedIn, and not to overstate things for any reasons, because plaintiffs look there, too.  LinkedIn users who overstate their authority, or their relationship, with a corporate defendant do that defendant a positive disservice in litigation.

That’s what we found when we looked into the matter.  Over and over, plaintiffs have resorted to LinkedIn in attempts to muddy the waters about both corporate domicile and corporate relationships.

As examples of the former – domicile related issues − the defendant lost on a venue motion in Virginia Innovation Sciences, Inc. v. Amazon.com, Inc., 2019 WL 3082314 (E.D. Tex. July 15, 2019), in part because of information on LinkedIn pages for it and its subsidiary tying it to activity in the relevant judicial district.  Id. at *5 n.6.  A similar loss occurred in City of Roseville Employees’ Retirement System v. Apple, Inc., 2021 WL 1176641 (N.D. Cal. March 29, 2021), where a corporate employee’s LinkedIn description of his duties led the court to conclude that he was a “general agent” for purposes of service of process.  Id. at *12.  See Philips Medical Systems (Cleveland), Inc. v. Buan, 2021 WL 1536173, at *9 (N.D. Ill. April 19, 2021) (employees’ LinkedIn profile supported “general manager” status for service of process; defendant offered no response on this point).

Conversely, the defendant won a similar motion in Ambriz Trading Corp. v. URALSIB Financial Corp., 2011 WL 5844115, at *6 (S.D.N.Y. Nov. 21, 2011), with a holding that “two vague LinkedIn pages that plaintiffs submit . . . are far too conclusory to establish that defendants actually maintain a presence” in the district.  Id. at 85.  See Universal Surface Technology, Inc. v. Sae-A Trading America Corp., 2011 WL 281020, at *2-3 (C.D. Cal. Jan. 26, 2011) (defendant’s employee’s LinkedIn profile did not establish employee as a “managing agent” for purposes of service of process).

Plaintiffs tend to be less successful in attempts to exploit LinkedIn information for jurisdictional purposes.  For instance, in Pyure Brands, LLC v. Nascent Health Science LLC, 2019 WL 7945231, at *5 (S.D. Fla. March 5, 2019), several screenshots of the defendant’s employees’ LinkedIn pages failed to establish plaintiff’s alter ego allegations.

It is almost self-evident that this evidence is inadmissible . . .: it is unauthenticated and refers to another unauthenticated exhibit, it is double hearsay, and even if it were admissible, it provides no evidence that [the parent] and [the subsidiary] share employees.  At best, it indicates that [one employee] stated on his social media that he worked for [the subsidiary] and provided a link to [the parent’s] website on his LinkedIn page, and that four self-described [subsidiary] employees described [the subsidiary] as a sales department of [the parent] on social media.  [The parent] denies [these claims] and, as [it] points out, it does not and cannot control the activity of [the subsidiary’s] alleged employees on social media.  Accordingly, the Court will not consider these exhibits and even if it did, would not find them to be persuasive evidence that [the parent] and [the subsidiary] share employees, let alone that [the parent] controls [the subsidiary.

Id. at *5.  See Strasner v. Touchstone Wireless Repair & Logistics, LP, 210 Cal. Rptr.3d 16, 24 (Cal. App. 2016) (employee’s LinkedIn description of himself as “president” of a subsidiary insufficient to establish agency for purposes of jurisdiction); Apple, Inc. v. Allan & Assocs. Ltd., 445 F. Supp.3d 42, 54-55 (N.D. Cal. 2020) (rejecting plaintiff’s alter ego theory where “one LinkedIn post ‘treated’ [two entities] as the same company . . . and that [parent defendant] owned both companies”); Fischer v. United States Life Insurance Co., 2020 WL 8921010, at *3 (D.N.D. Nov. 12, 2020) (employees’ LinkedIn use of the parent defendant’s name “for branding and marketing purposes” insufficient to establish specific personal jurisdiction); National Steel Car Ltd. v. Greenbrier Cos., 2020 WL 4289388, at *4 (W.D. Tex. July 27, 2020) (employees’ LinkedIn affiliations insufficient to support corporate alter ego claim); Roman v. Affinity Worldwide, LLC, 2020 WL 8339208, at *4 (W.D. Mo. April 23, 2020) (“Without more than a screenshot from [the franchisor’s] LinkedIn page, the Court cannot find that Plaintiff has made a prima facie showing the listed individuals are employees of [the franchisor] − and not [a franchisee].”; personal jurisdiction denied); In re Del Valle Ruiz, 342 F. Supp.3d 448, 456 (S.D.N.Y. 2018) (defendant’s chief executive’s LinkedIn affiliations held insufficient, even with other contacts, to create general personal jurisdiction), aff’d, 939 F.3d 520 (2d Cir. 2019); Gourdine v. Karl Storz Endoscopy-America, Inc., 223 F. Supp.3d 475, 489 (D.S.C. 2016) (the “the wording of some former [defendant’s] employees’ Linkedin pages” insufficient to establish personal jurisdiction); Barantsevich v. VTB Bank, 954 F. Supp.2d 972, 985 (C.D. Cal. 2013) (defendant’s subsidiary’s LinkedIn page did not establish agency status for personal jurisdiction purposes).  Cf. Commonwealth Science & Industrial Research Organization v. Real Communications, Inc., 2013 WL 12141420, at *3 (E.D. Tex. Sept. 18, 2013) (alleged “blur[ring] the line between the corporations online in their LinkedIn profiles” insufficient to establish personal jurisdiction, but justified allowing jurisdictional discovery), second motion to dismiss granted 2014 WL 12605377 (E.D. Tex. Aug. 8, 2014).  But see PetroSaudi Oil Services, Ltd. v. Hartley, 617 S.W.3d 116, 126-27, 9 (Tex. App. 2020) (LinkedIn profiles of several of defendant’s employees, along with other evidence, supported finding of general jurisdiction); Concepts NREC, LLC v. SoftInway, Inc., 2021 WL 916259, at *5 (D. Mass. March 10, 2021) (LinkedIn descriptions of corporate subsidiary and its personnel featured prominently in decision to consider subsidiary an alter ego subject to personal jurisdiction); Johnson v. CL Medical SARL, 2016 WL 9665160, at *3 (C.D. Ill. July 15, 2016) (refusing to “overlook” claimed “imprecision” of LinkedIn descriptions and finding they supported specific personal jurisdiction); Ray v. Mechel Bluestone, Inc., 2016 WL 865322, at *4 (S.D.W. Va. March 2, 2016) (plaintiffs successfully relied on employee’s LinkedIn profile in meeting one factor of Warn Act control test), reconsideration granted in part on other grounds, 2016 WL 11670062 (S.D.W. Va. May 3, 2016).

The defendants still manage to win most of these cases, since most courts consider unauthenticated LinkedIn “evidence” to be unreliable hearsay.  The main point, however, is that plaintiffs are attempting to take advantage of what almost always amounts to self-inflicted wounds.  We defense counsel get involved only after the fact.  Inaccurate, usually overstated, LinkedIn profiles always cost clients more in terms of defense costs, and sometimes result in critical lost motions.  And the problem is only getting worse.  Almost half of the cases we’ve cited in this post have been decided since 2020.  We urge everyone on the defense side, particularly in-house, to take steps to ensure that LinkedIn descriptions are accurate, current, and not exaggerated in ways that harm the defense of litigation.