Truly unique cases are, well, unique. Most cases involve variations or combinations of cases we have seen before. Sometimes you get different results between two decisions on basically the same case with a single fact different. In February, we posted on an Eastern District of Pennsylvania decision on a motion to dismiss in a case involving allegations about severe hypophosphatemia (“HPP”) with a prescription injection for iron deficient anemia. The decision applied Pennsylvania law and was a mixed bag.  Pennsylvania, of course, does not have strict liability for prescription medical products, so those asserted claims went away. Most of the rest of the decision was not so great for the good guys, though.

In Atkinson v. Luitpold Pharms., Inc., No. 19-277, 2020 WL 1330705 (E.D. Pa. Mar. 23, 2020), the same court ruled on a similar motion to dismiss involving pretty much the same complaint about the same injury with the same prescription drug. The main difference is that Atkinson applied Texas law. Texas really has not been the plaintiffs’ paradise of yore (and lore) for some time. This has been driven in part by the enactment in 2003 of §82.007 of the Texas Civil Practice and Remedies Code. In addition to having a cool number—we leave it to others to suggest a Bond movie marathon to pass the days or offer an appropriate recognition of the passing earlier this week of Honor Blackman—the provision creates a rarely rebuttable presumption on non-liability for failure to warn claims where a drug’s label has been approved by FDA. Among the enumerated bases for rebutting that presumption is where the defendant “withheld from or misrepresented to the United States Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related to the claimant’s injury”—i.e., committed fraud on the FDA in Buckman parlance. PA has nothing like that. The provision’s relative novelty has led to a fair amount of attention and a bunch of posts over the years.

Briefly, Atkinson involves a complaint alleging a range of design and warnings claims related to the risk of HPP with the drug, which was approved in 2013 after two prior non-approvable letters driven by concerns about HPP. As could be expected, the launch label contained information approved by FDA about HPP in multiple sections. Plaintiff, who was prescribed and administered the drug once in 2016, claimed to have developed HPP and criticized the strength of the HPP information in the label. (She also criticized changes to the label after her prescription, but that is of no matter.) Defendants—the NDA holder and three other companies—moved to dismiss, largely based on preemption given §82.007. Plaintiff’s response included the contention that she could rebut the presumption based on the fraud-on-the-FDA exception. Thus, the issue—the one we care most about—was joined.

The court started its analysis, from our perspective, a little backwards. Rather than starting with what plaintiff asserted and what Texas law said about it—e.g., what claims exist, what is required to prove them—the court started with a discussion of preemption, starting with this curious statement:

Defendants argue that any of Plaintiff’s claims that are premised on a failure to warn are preempted by federal law in that they boil down to the theory that Injectafer should have been labeled and designed differently despite FDA approval of the existing label and design.

Id. at *3. This came with a footnote saying the defendants challenged only pre-approval warnings and design claims, the plaintiff did not claim a post-approval design claim, and defendants did not challenge the post-approval warning claim. We will save our ink on all of that and simply note that the approach here allowed the court to follow its approach in Crockett and conclude a pre-approval design claim was not preempted. Id. As we have said before, if any claim is preempted in a prescription drug product liability case, then it is one premised on the argument that the drug should have had a different design when it was approved. With this issue punted away, the court turned to the Texas statute and, in short order, Buckman.

Plaintiff’s concession that she could avoid the presumption of non-liability for all the warnings claims she asserted only by proving that defendants had “withheld from or misrepresented to the United States Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related to the claimant’s injury” teed up the precise issue about the Texas statute.

Although a handful and some cases have evaluated whether it (or a substantially similar Michigan statute) is preempted by the Buckman rationale, the Third Circuit has not.

Id. at *5. The court cited Lofton, Garcia, and some lower court cases in the Third and Fifth Circuits on the preemption side and Desiano and some lower court cases in the Third Circuit on the no preemption side. After reviewing the circuit cases in some depth—although with a bit too much on the debunked presumption against preemption for our taste—the court looked primarily to Lofton as the most persuasive and on-point. The “the only federal appellate court to have interpreted the Texas exception at issue here,” happened to be one “conversant in Texas law,” and “it did so in a factually analogous circumstance involving common law tort claims after carefully considering the counter-arguments made in Desiano.Id. at *7.

Following Lofton and noting that plaintiff’s fraud allegations did not include the claim that FDA had ever determined HPP risk information had been withheld, Buckman precluded plaintiff from trying to fight the presumption against warnings claims. Id. That did away with five of plaintiff’s counts grounded in failure to warn, including a fraud count that was based on “failure-to-warn allegations cast under a different heading.” Id. at *8.

Another domino fell because Texas follows comment k and, as discussed above, the presumption of adequate warnings held. That means plaintiff’s design defect claim was also dismissed. All that was left for the court was the issue of whether plaintiff had pled a failure to test claim, which Texas recognizes as a species of negligence. Her general negligence and “gross negligence” allegations did not come close, but, as with most initial challenges to the adequacy of pleading, plaintiff was permitted another shot to get it right. If she does not come up with enough allegations to revive a gross negligence claim, then her punitive damages claim will also stay dismissed. Even with something of plaintiff’s complaint remaining, there was not enough to support punitive damages. That last bit was a holding under either Texas or Pennsylvania law. The rest was pure Texas.

Some states seem stronger on FDA preemption than SCOTUS was in the Wyeth v. Levine decision. For example, Michigan, New Jersey, and Texas prevent or limit the ability of plaintiffs to sue over an FDA-approved drug, including attacks on the FDA-approved label. See, e.g., Texas Civ. Prac. & Rem. Code Ann. § 82.007. Sometimes those statutes afford plaintiffs an out under certain circumstances. Some of those outs make sense (e.g., if the medicine was sold after it had been ordered withdrawn by the FDA) and some do not (e.g., off-label use or promotion). The most controversial out allows plaintiffs to sue over an FDA-approved drug if the plaintiff can show that such approval happened only because the FDA had been hoodwinked. That translates into a claim of fraud on the FDA, and that, in turn, is preempted by Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). If anyone is going to decide whether the FDA had been defrauded, it should be the FDA, not some state jury whipped into a frenzy by cherry-picked documents and reptilian rhetoric. Thus, the exception is null and void and the plaintiff is still out of luck.

That’s our position, of course. We could say that reasonable minds can disagree, but we don’t believe that for a second. When appellate courts come out on opposite sides as to whether a state fraud-on-the-FDA exception was preempted, we have no trouble saying that the courts holding preemption — Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d 372 (5th Cir. 2012) (applying Texas law) (discussed here), and Aron v. Bristol-Myers Squibb, 2018 U.S. Dist. LEXIS 39146 (S.D.N.Y. Mar. 9, 2018) (applying Texas law) (discussed here) — were right, while the courts holding no preemption — Desiano v. Warner Lambert & Co., 467 F.3d 85, 95 (2d Cir. 2006) (applying Michigan law), aff’d by equally divided court, 552 U.S. 440 (2008), and Tigert v. Ranbaxy Pharmaceuticals, Inc., 2012 WL 6595806 (D.N.J. Dec. 18, 2012) (applying Texas law) — were wrong.

The plaintiff in Kumaritakis v. AstraZeneca Pharmaceuticals LP, 2020,WL 1024933 (Del. Super. Ct. March 2, 2020), was apparently spoiling for a fight on this issue. She claimed that she had been injured by taking an FDA-approved diabetes drug. Her causes of action included negligence and failure to warn. The parties agreed that Texas law governed, so the plaintiff ran smack against section 82.007. Right out of the chute, the plaintiff argued that the FDA fraud exception was not preempted. That should be a flat-out loser. And so it was in this case, but not for the reason you’d expect. The Delaware court was able to side-step the preemption point because the plaintiff never bothered to argue that any of the exceptions actually applied. Indeed, the plaintiff said she was not alleging that the defendant misrepresented or withheld information from the FDA.

Well, that was easy.

Why are we even writing about the Kumaritakis case? Isn’t this just an odd instance of a plaintiff shooting herself in the foot? What useful lesson emerges from this case? Well, one lesson might be to check whether the plaintiff has skipped a step or two in the rush to join issue on the most difficult or important legal dispute. (Think of so-called “parallel claim exception” cases in which plaintiffs never bothered to show any legitimate state law claim.)

There is another aspect of the Kumaritakis case that is interesting. The plaintiff also brought a cause of action for design defect She claimed that a safer design existed. Maybe so, but under FDA regulations, once a drug is approved “the manufacturer is prohibited from making any major changes in the ‘qualitative or quantitative formulation of the drug product, including inactive ingredients, or in the specifications provided in the approved application.’” Essentially, the plaintiff was singing that old Huey Lewis and the News song, “I Want a New Drug.” The court’s response was, “Yeah, well you’re not getting one until the FDA approves it.” The defendant could not change its medicine without FDA approval. That is straight-on impossibility preemption.

It seems to us that this sort of preemption is ineluctable and obvious, and should consign almost all pharma design defect claims to the litigation boneyard.

Sometimes the DDL blog is ahead of the curve.  On more than one occasion we’ve advanced the idea that lack of personal jurisdiction should be a good defense to innovator liability in a post-BMS world.  After all, BMS held that there was no specific jurisdiction over a plaintiff’s claim just because the defendant allegedly sold the drug at issue to other, in-state residents, causing similar injuries:

The mere fact that other plaintiffs were prescribed, obtained, and ingested [the drug] in California − and allegedly sustained the same injuries as did the nonresidents − does not allow the State to assert specific jurisdiction over the nonresidents’ claims.  As we have explained, “a defendant’s relationship with a . . . third party, standing alone, is an insufficient basis for jurisdiction.”

Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773, 1781 (2017). (quoting Walden v. Fiore, 134 S.Ct. 1115, 1123 (2014)).  Rather, “case-linked” personal jurisdiction requires case-linked conduct by the defendant within the jurisdiction.  Under BMS, where does the “case-linked” conduct of the branded defendant take place in an innovator liability case?  That conduct does not include sale of a product.  The defendant did not sell the allegedly injurious product, but only a different bioequivalent product with the same risks.  Sale of a different product to different people, even if those other people are in-state residents, can’t support specific, “case linked” personal jurisdiction.

Now, we have a case that puts those ideas into practice – Henry v. Angelini Pharma, Inc., 2020 WL 1532174 (E.D. Cal. Mar. 31, 2020).

Plaintiff, a California resident, was prescribed and ingested generic trazodone for insomnia.  He alleges that the trazodone caused him to experience priapism, a prolonged penile erection, lasting over 24 hours and he is now impotent.  Id. at *1.  Plaintiff brought claims for strict liability, negligence, breach of implied and express warranties, negligent misrepresentation, negligence per se, and punitive damages against the manufacturer of the generic trazodone as well as companies involved with its branded competitor.  On the brand side, one of the defendants was an Irish company with a U.S. headquarters in Pennsylvania who was the successor to the original brand manufacturer.  The other brand defendant was the current brand NDA holder, a Delaware corporation headquartered in Maryland.  Plaintiff alleged the brand label had an inadequate warning which in turn was used by the generic manufacturer.  Brand defendants moved to dismiss for lack of specific jurisdiction.

The Ninth Circuit uses a three part test to determine whether specific jurisdiction exists:  (1) defendant must have purposefully availed itself of the privilege of conducting activities in the state by an affirmative act or conduct; (2) plaintiff’s claim must “arise out of or result from” those activities; (3) the exercise of jurisdiction must be reasonable.  Plaintiff bears the burden of proof on the first two prongs.  Id. at *2.

Defendants’ argument was correctly centered on the lack of a connection between the state, plaintiff’s alleged injury, and any activity on their part.  Plaintiff’s opposition focused solely on the fact that according to LinkedIn, five years before plaintiff was prescribed trazodone, defendants employed a sales representative to market the brand drug in California.  Id. at *4.  Plaintiff further theorizes that the brand rep “almost certainly” misrepresented the risk of priapism to healthcare providers in California.  Id.

The court’s analysis begins as it ought to:  “Plaintiff’s claim arises from taking a drug in California that was not manufactured by [brand defendants].”  Id.  Hence, it is an innovator liability claim.  “The trouble with this attenuated legal theory is that there is nothing that ties Plaintiff’s claim to Defendant’s activities in California.”  Id.  As for the lone sales rep:

Plaintiff fails to explain how the actions of a single salesman in California, marketing and selling a drug Plaintiff did not take to an unknown number of practitioners, four to five years before an injury that was caused by a different drug manufactured by [a different defendant], has anything to do with Plaintiff’s claims.

Id.  That is BMS, except BMS involved the same product, not a bioequivalent generic.  Selling a drug the plaintiff did not take, here the brand version, to others in the state does not satisfy specific jurisdiction.

In an attempt to avoid dismissal, plaintiff requested a transfer to Maryland.  But a case can only be transferred to a court with subject matter jurisdiction that is a proper venue and where defendant is subject to personal jurisdiction.  And where there are multiple defendants, the personal jurisdiction and venue requirements must be satisfied as to all defendants.  Id. at *5.  As noted above, one of the brand defendants had a principal place of business in Maryland.  As to the other brand defendant and the generic manufacturer, plaintiff argued that their FDA-related interactions in the form of ANDA filings (generic manufacturer) and submission of the drug’s warning (brand defendant) were jurisdictional contacts conferring jurisdiction in Maryland.  Id. With no Ninth Circuit law on point, the court found Zeneca Ltd. v. Mylan Pharm., Inc., 173 F.3d 829 (Fed. Cir. 1999) persuasive.  Allowing government contacts to serve as jurisdictional contacts “would be contrary to the policy against the creation of national supercourts in Maryland and may offend due process.”  Henry, at *5 (quoting Zeneca).

Plaintiff is a California resident who was prescribed [ ] generic trazodone by his physician in California, the drug was dispensed and ingested in California, and the resulting injury occurred in California. The Court declines to find that [defendants] are subject to specific jurisdiction in Maryland based on nothing more than their FDA filings and the unsubstantiated possibility that [generic defendant] also sold its drug in Maryland. Based on the limited information before this Court, it is not clear that Maryland can exercise personal jurisdiction over all Defendants.

Id.  Plaintiff gets to continue its case against the generic defendant in California.  But, we know how those cases usually go.

Henry now gives us precedent to cite to support our previously posited position that the lack of case-related in-state conduct means that there can’t be specific personal jurisdiction over a branded defendant sued for no reason other than the plaintiff being injured in a state recognizing innovator liability.  Branded defendants sued outside their home states on innovator liability claims should raise personal jurisdiction as a defense.  Don’t forget it’s a waivable defense.

This Wednesday evening marks the beginning of the Jewish holiday of Passover. In every other year, our large extended family has gathered for Seder, a ritual dinner that commemorates, with traditional foods, songs, and prayers, the exodus of the Israelites from slavery in ancient Egypt. In our family, Seder is a beloved (and occasionally raucous) affair.   Obviously, no one will “gather” this year.   All are disappointed, but the Drug and Device Law Dowager Countess, well into her ninth decade, is crestfallen. And so the weekend included endless text chains and too many conference calls, the result of which was a decision to conduct a “virtual” seder using “meeting” technology.   It is not a perfect solution. But it recognizes that we can adapt to the moment without scuttling decades of family tradition.

If only Pennsylvania’s federal courts could strike a similar balance in cases involving comment k to Section 402A of the Restatement (Second) of Torts. Comment k exempts the manufacturers of “unavoidably unsafe products,” including prescription drugs, from strict liability for allegedly defective designs.   Pennsylvania jurisprudence has long recognized that there is no principled basis for a distinction between drugs and medical devices and has extended the comment k exemption to manufacturers of all prescription medical products, including drugs, devices, and vaccines.

Recently, as we told you here and here, both the Eastern and Western Districts of Pennsylvania have issued abominable opinions holding that comment k does not apply to medical devices. Today’s case, James v. Siemens Medical Solutions USA, Inc., 2020 U.S. Dist. LEXIS 57847 (E.D. Pa. Apr. 2, 2020), is the latest decision in this lamentable trend.

James is an unusual case.   The medical device in question was not implanted in the body; rather, it was an imaging scanner. And the plaintiff’s injuries were not related to the device’s medical function. The plaintiff was placed in the device for an imaging study, but he was so tall that his feet hung over the edge of the machine.   When the machine started to move, it crushed the plaintiff’s feet. The plaintiff asserted strict liability claims against the machine’s manufacturer. The defendant filed a 12(b)(6) motion arguing that comment k immunized it, as a manufacturer of medical devices, against the plaintiff’s strict liability claims. In denying the motion, the court made at least two critical mistakes.

The court explained that Pennsylvania had adopted comment k in Hahn v. Richter, 673 A.2d 888 (Pa. 1986), “preclud[ing] all strict-liability claims against prescription drug manufacturers.” James, 2020 U.S. Dist. LEXIS 57847 at *6.   But then the court stated that the defendant was asking it “to extend Hahn [to] immunize medical device manufacturers” from strict liability claims. Id. This is the first place where the court got it very wrong. To hold that comment k bars strict liability claims against medical device manufacturers, the court didn’t have to “extend” anything – it simply had to follow decades of Pennsylvania appellate precedent as well as more than forty Pennsylvania federal decisions. But the court bought into the plaintiff’s argument that “recent guidance” from Lance and Tincher was fatal to the defendant’s argument. As we have explained in these pages, neither Lance nor Tincher limited the application of comment k. Lance held only that comment k did not apply to negligence actions, and Tincher did not deal with pharmaceutical products at all.

The court also suggested that the defendant’s product was not a “medical device” at all. We think this is wrong, too.   As technology advances, jurisprudence must keep pace, and medical innovations far beyond traditional implanted devices deserve the protection afforded to “unavoidably unsafe products.”

In any event, this is another in a series of bad comment k decisions.  Much of our professional life is devoted to the defense of medical device manufacturers, and we fear this trend.  We will keep you posted as decisions fall on both sides of the comment k scale. In the meantime, stay safe in this unprecedented moment in which we all find ourselves.

At this point, let’s call it what it is: anti-social distancing.  The second word follows much better from that first word.  They go together.  Always have.  It gives you the right mindset too.  When you go for a perilous walk around the block, and you see someone doing the same thing, and they start coming too close to you: “Get the **** away from me.”  Voila, distancing.  Anti-social distancing.  It works.  Then you go back inside.  The same people are there, and you head back into your tiny office and find some work to do.  You get back up, go get a little too much to eat and return to your tiny office.  You talk on the phone or stare at grids of videos on your screen.  From your tiny office.  It’s all so anti-social and distant.  It’d be nice to have immunity from this thing.  At least you’d lose the worrying, but you probably wouldn’t lose the distancing that everybody else would still practice on you.  Ah, well.

The defendants had immunity in Sharp v. Ethicon, Inc., 2020 WL 1434566 (W.D. Ark. Mar. 24, 2020), or at least something very like it.  Its name was Dr. Crownover.  The defendants didn’t even need a warning with him.  Adequate or inadequate, he took care of it.

The plaintiff had complications from her pelvic mesh surgery.  Her surgeon was Dr. Crownover.  After remand back to Arkansas (source of the applicable law), plaintiff simply surrendered over a dozen claims on her MDL short-form complaint that probably never should have been there, all that was left for defendants to seek summary judgment against was plaintiff’s failure to warn claim.  Id. at *1.  Plaintiff claimed that the warnings in the instructions for use were inadequate.

Dr. Crownover basically gave defendants immunity.  He knew that the pelvic mesh product, called a TVT-O device, had a wide range of potential complication that could be mild, moderate or severe:

[Dr. Crownover] was aware—both at the time of his deposition and at the time of Ms. Sharp’s surgery in 2010—that there were certain risks associated with the TVT-O device, including wound complications, fistula formation, inflammation, neuromuscular problems, the need for one or more surgeries to treat an adverse event, the possible recurrence of the underlying medical condition or the failure of the device, erosion/exposure/extrusion of the mesh, and contraction of the tissues.  He agreed that all of these complications could be “mild, moderate, or severe.”

Id. at *4.  While he likely read the instructions for use, he didn’t rely on them.  He relied on his own training and experience and the medical literature.  Id.  Dr. Crownover then landed the haymaker.  Even the additional warning plaintiff was seeking would not have changed his decision to prescribe the TVT-O device:

Q If Ethicon had included in the TVT IFUs the words found under the mesh column in Exhibit No. 8, is it correct to say that those additional words being added to the IFUs would not have changed your decision to prescribe the TVT-O for Ms. Sharp?

A They would not have influenced whether I offered that or not.

Id.

There goes but-for causation and proximate causation.  The court granted summary judgment.  Id. at *4-5.  The learned intermediary doctrine works so well when the doctor is, in fact, learned.

OK, I’m now going to post this thing on the website for you.  Then to the refrigerator.  Then back to the tiny office.  Ah, well.

We’ve blogged several times before how the logic of the United States Supreme Court’s decision in Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017), dooms nationwide class actions against corporations – except in jurisdictions where they are “at home.”  BMS held, essentially, that a non-resident plaintiff could not sue a non-resident corporate defendant over injuries that did not occur in the forum – and that the presence of other, resident plaintiffs asserting the same claims didn’t create personal jurisdiction that otherwise wouldn’t exist.  “In order for a state court to exercise specific jurisdiction, the suit must arise out of or relate to the defendant’s contacts with the forum,” so that “there must be an affiliation between the forum and the underlying controversy, principally, an activity or an occurrence that takes place in the forum State and is therefore subject to the State’s regulation.”  Id. at 1780; see also Id. at 1781 (lack of specific jurisdiction “remains true even when third parties (here, the plaintiffs who reside in California) can bring claims similar to those brought by the nonresidents”); 1783 (personal jurisdiction requirements “must be met as to each defendant over whom a state court exercises jurisdiction”; the “bare fact” that defendant has a “contract[] with” an in-state resident “is not enough”).

But that is exactly what any multi-state class action against a non-resident corporation necessarily does, since a large number of putative class members will necessarily be non-residents as well – with no injuries, and indeed no contact at all, with the forum jurisdiction.

BMS did not involve class actions, but the Court was well aware of the potential impact its ruling might have on purported nationwide classes, since this eventuality was mentioned in Justice Sotomayor’s lone dissent.  Id. at 1789 n.4 (BMS “does not confront the question whether its opinion here would also apply to a class action in which a plaintiff injured in the forum State seeks to represent a nationwide class of plaintiffs, not all of whom were injured there”).

The class action plaintiffs’ bar – their business model being threatened by BMS – launched a furious counter attack, claiming “we’ve always done it this way,” unnamed class members don’t count, and that class actions are different from other types of litigation.  We’ve rebutted these arguments at length in our prior posts and won’t go into them in any detail here.  A three sentence thumbnail:  One:  For decades before Daimler AG v. Bauman, 571 U.S. 117 (2014), everyone thought “continuous and substantial” business supported general jurisdiction – “always done it this way” doesn’t defeat due process.  Two:  The Rules Enabling Act precludes Rule 23 from creating personal jurisdiction for a claim where, without the class action mechanism, it would not exist.  Three:  Fed. R. Civ. P. 82 explicitly provides that the rules of civil procedure “do not extend or limit the jurisdiction of the district courts or the venue of actions in those courts.”

But unfortunately, it looks like this personal jurisdiction issue is going to require the Supreme Court, once again, to pick up that two-by-four, and beat the lower courts into compliance with due process as construed in BMS and Bauman.

Two courts of appeals recently looked at that question.  The Seventh Circuit, in Mussat v. IQVIA, Inc., ___ F.3d ___, 2020 WL 1161166 (7th Cir. March 11, 2020), succumbed to the “we don’t wanna change, and you can’t make us” mantra of the plaintiffs’ class action bar:  “Decades of case law show that this has not been the practice of the federal courts.”  Id. at *3.  Defendant “urges a major change in the law of personal jurisdiction and class actions.”  Id. at *5.  Mussat goes on to cite several decisions that ignore absent class members with respect to diversity jurisdiction and venue.  Id. at *4.  But Mussat ignores a critical difference.  Those cases all involved statutes:  28 U.S.C. §1332, 28 U.S.C. §1367 (jurisdiction), and 49 U.S.C. §16(4) (venue under the Interstate Commerce Act).  Mussat, however, construes nothing but Rule 23 – and Rule 23 cannot change the substantive rights of the parties or the substantive requirements of constitutional law.  The same goes for Fed. R. Civ. P. 4, which Mussat attempts to draft into the expansion of personal jurisdiction for class actions.  2020 WL 1161166, at *5.

We continue to believe that all litigants are entitled to the same due process, and that due process (whether under the 5th or 14th Amendments) applies in the same way to defendants in all litigation – individual (Walden v. Fiore, 571 U.S. 277 (2014)), mass action (BMS), or class actions.  No Federal Rule of Civil Procedure can change the stark fact that, if Plaintiff A can’t get personal jurisdiction over Defendant B in Jurisdiction C, then an entire class of Plaintiff As can’t use Rule 23 to sue Defendant B in Jurisdiction C for the exact same thing.  Due process, the Rules Enabling Act, and the Federal Rules themselves all forbid it.  See Tyson Foods, Inc. v. Bouaphakeo, 136 S. Ct. 1036, 1048 (2016) (a court “violate[s] the Rules Enabling Act by giving plaintiffs and defendants different rights in a class proceeding than they could have asserted in an individual action”).

In the second decision, the District of Columbia Circuit decided to punt.  Molock v. Whole Foods Market Group., Inc., ___ F.3d ___, 2020 WL 1146733 (D.C. Cir. March 10, 2020).  The class plaintiffs in Molock took the extreme position that “[Rule] 23 permits a federal court sitting in diversity to exercise personal jurisdiction over unnamed, nonresident class members’ claims, even if a state court could not.”  Id. at *2.  That, of course, directly implicated the Rules Enabling Act and Rule 82.

Rather than apply BMS to class actions, a 2-1 panel majority in Molock found prematurity, even though plaintiffs had never raised that issue in the district court:

It is class certification that brings unnamed class members into the action and triggers due process limitations on a court’s exercise of personal jurisdiction over their claims.  Any decision purporting to dismiss putative class members before that point would be purely advisory. . . .  Motions to dismiss nonparties for lack of personal jurisdiction are thus premature. . . .  Because the class in this case has yet to be certified, [defendant’s] motion to dismiss the putative class members is premature.

2020 WL 1146733, at *3 (citations omitted).  According to Molock, only after class certification may a defendant challenge a court’s personal jurisdiction over absent class member.  Id. (“Only after the putative class members are added to the action − that is, when the action is certified . . . − should the district court entertain [defendant’s] motion to dismiss the nonnamed class members.”).  Molock thus requires class action defendants to sacrifice themselves to the prospect of massive classwide liability in order to assert their due process rights under BMS.  That is ironic in the extreme, since:

In determining whether personal jurisdiction is present . . . the “primary concern” is “the burden on the defendant.”

BMS, 137 S. Ct. at 1780 (quoting World-Wide Volkswagen Corp. v. Woodson, 444 U.S. 286, 292 (1980)).

The dissent in Molock recognized that the prematurity argument was ridiculous.  “[A] hypothetical named plaintiff would be entitled to extensive class discovery even after an on-point decision by the Supreme Court concluding, as I do, that the principles in [BMS] extend to class actions.”  2020 WL 1146733, at *8 (Silberman, J., dissenting).  And the dissent got the merits right, too:

[F]or the question at hand, the party status of absent class members seems to me to be irrelevant.  The Court’s focus in [BMS] was on whether limits on personal jurisdiction protect a defendant from out-of-state claims, and a defendant is subject to such claims in a nationwide class action as well.  A court’s assertion of jurisdiction over a defendant exposes it to that court’s coercive power, so such an assertion must comport with due process of law.  A court that adjudicates claims asserted on behalf of others in a class action exercises coercive power over a defendant just as much as when it adjudicates claims of named plaintiffs in a mass action. . . .  And much like the class action mechanism cannot circumvent the requirements of Article III, it is not a license for courts to enter judgments on claims over which they have no power.  A defendant is therefore entitled to due process protections − including limits on assertions of personal jurisdiction − with respect to all claims in a class action for which a judgment is sought.

Id. at *10 (citations and footnote omitted).  Even if Congress could, by statute, authorize nationwide class actions under state law “Congress has done no such thing.”  Id. at *11.

[T]he limits that do follow from applying [BMS] to class actions in federal court are no different from the limits that apply when individual plaintiffs sue on their own behalf, and that must be tolerated under current law.  For example, it is true that plaintiffs likely would be unable to bring a unitary nationwide class action against two or more defendants who are subject to general jurisdiction in different states. . . .  But similarly an individual plaintiff − not a class action − ordinarily cannot bring these sorts of defendants into a court to answer to claims that have nothing to do with the forum.  And procedural tools like class actions and mass actions are not an exception to ordinary principles of personal jurisdiction.

Id. (citations omitted) (emphasis added).

Nuff said.  Take it to the Supreme Court.

Last week we discussed the Jacob v. Mentor Worldwide, LLC case, in which a pro se plaintiff alleged injuries from breast implants and complained that the manufacturer had inadequately warned of the risks. The claim boiled down to an attack on the FDA-approved labeling of a class III medical device, and that meant it was preempted. The court dismissed the case in its entirety, but gave leave to amend. We said we awaited the outcome of further proceedings.

Well, that was dim-witted of us. The opinion we blogged about was from last July. Any decent associate would have Shepardized the case and learned that the plaintiff had, in fact, amended the complaint, and the court did, in fact, dismiss it yet again. (That happened on December 10, 2019.) But in our self-quarantined, self-pitying, terrified news-watching, ice cream-eating state, we dropped the ball. Luckily, the attentive, diligent, victorious, omnicompetent defense counsel folks at Tucker Ellis filled us in on what the medical experts would call the sequelae.

The plaintiff, still acting pro se (you can see where this is going, right?), amended the complaint to allege claims of violation of premarket approval, breach of implied warranty, and lack of informed consent (failure to warn) against the manufacturer. But the pro se doctor plaintiff did not stop there. She also alleged a medical malpractice claim against her doctor, as well as claims against the American Society of Plastic and Reconstructive Surgeons (ASPRS) and the FDA.

Let’s start with the new defendants. The medical malpractice claim was barred by Florida’s medical-negligence four year statute of repose. That four year period precludes lawsuits against medical providers no matter when the plaintiff discovered the alleged negligence. Moreover, the plaintiff had not complied with the pre-lawsuit screening process that Florida requires (as do many other jurisdictions) plaintiffs to go through prior to filing a lawsuit. All of that is just another example of doctors getting much more favorable legal treatment than the smart and kind people who invent the products that allow doctors to do what they do. One would have thought that the pro se plaintiff, who was a doctor herself, might have been aware of these procedural hurdles. But we digress. The cause of action against the ASPRS failed because there was no privity between the plaintiff and that organization, nor was there any causal nexus in sight between the ASPRS and the plaintiff’s injuries. As for the claim against the FDA, there are two words that slam the door shut: sovereign immunity.

The amended claims against the manufacturer weren’t really so amended. The court held that the amendments did “not satisfy the Court’s July 17, 2019 order,” “failed to cure the deficiencies,” and were merely an attempt “to repackage the previously preempted claims.” The ‘new’ claims, at bottom, were still gripes about a failure to warn. That sorry sameness again banged against Riegel and Buckman preemption. This time the court dismissed the case with prejudice.

So at least when we likened the plaintiff to Sisyphus, we weren’t wrong. She pushed the rock, the amended complaint, up a hill, and it rolled right back down. Now we have learned that the plaintiff has filed an appeal with the Eleventh Circuit. It looks to us like yet another push of the rock up the hill.

Almost two months ago we posted on the magistrate’s Report and Recommendation in Drescher v. Bracco Diagnostics Inc., 2020 WL 699878 (D. Ariz. Jan. 31, 2020).  Back when our co-workers didn’t include furry, four-legged friends.  When we weren’t also re-learning high school geometry.  And when pajamas and slippers weren’t acceptable work attire.  Many things have definitely changed.  Fortunately, the result of Drescher isn’t one of them.

Following the magistrate’s dismissal of all claims, over plaintiff’s objections, the court adopted the magistrate’s findings in full and authored a thoughtful opinion of its own.  Drescher v. Bracco Diagnostics Inc., 2020 WL 1466296 (D. Ariz. Mar. 26, 2020).  As a reminder, plaintiff underwent MRIs in 2013, 2015, and 2016 before each of which she was injected with a linear gadolinium-based contrast agent (GBCA) manufactured by defendants.  Plaintiff had normal kidney function at the time of her GBCA injections.  She alleges that she has retained gadolinium in her organs that is causing fibrosis and related symptomology.  Plaintiff brought causes of action for failure to warn and defective design under both negligence and strict liability.  Id. at *1-2.  Plaintiff raised three objections to the magistrate’s recommendation.

First, plaintiff claimed that the magistrate did not draw all reasonable inferences in her favor.    But plaintiff failed to identify what those inferences should have been.  Id. at *4.  That’s because plaintiff only made conclusory causation allegations that not only weren’t supported by the facts, but were actually contradicted by them:

Rather, the information provided by Plaintiff shows that the FDA found, after inquiry and studies, that it could not establish a causal association between adverse health effects reported by patients with normal kidney function and gadolinium retention.

Id.  Because plaintiff’s allegations were merely speculative or not facially plausible, the magistrate correctly applied the TwIqbal standard in dismissing the case.

Second, plaintiff took issue with the magistrate’s finding that the FDA found no causal nexus between GBCA and adverse health effects in patients with normal kidney function.  Id.  Plaintiff argued that FDA’s 2018 label change was “reasonable evidence” of a causal association.  But the label change stated:  “adverse events involving multiple organ systems have been reported in patients with normal renal function without an established causal link to gadolinium retention.”  Id. at *5.    Essentially, plaintiff was asking the court to overlook the FDA’s findings and “to draw an inference that is both unsupported and explicitly contradicted by the record before it.”  Id.  The court was unwilling to do so.

Finally, plaintiff argued that the magistrate erred in finding that her design defect claim was barred by Restatement (Third) of Torts §6(c).  The court begins its analysis by addressing what plaintiff failed to – that her design defect claim was also dismissed as preempted.  The court agreed with the magistrate that a design defect claim would require defendant to alter the formulation of its product, something not allowed without FDA approval.  Id.   Plaintiff’s argument that defendant should have sold a different type of GBCA, or stopped selling its GBCA, was also preempted under Mutual Pharm Co., Inc. v. Bartlett, 570 U.S. 472, 488 (2013).

The court then turned to §6(c) and its requirement that defendant’s “duties with respect to product design apply only to foreseeable risks of harm.”  Id. at *6.  Based on the record provided by plaintiffs, the court was unable to draw an inference that the risks of GBCAs to patients with normal kidney function were foreseeable given the FDA’s findings.  Id.

So, the court adopted the magistrate’s report and recommendation in full.  We emphasize that because the magistrate’s report ended with an admonishment to plaintiff that she should only file an amendment complaint if she had additional factual support for at least one claim.  We hope plaintiff takes that part to heart.  We don’t think any more time or resources should be spent turning this into a trilogy.

When times are tough, attempted humor can fall flat. Opinions often add little. Fancy prose and witty turns of phrase count for little. Facts, for those whose preconceived notions allow them to be received as such, matter. The language of statutes—potentially powerful drivers of needed stability or change—should be easy to understand even without reference to additional documents on legislative intent (let alone any resort to purported executive intent). With that preface, we will keep simple and play it straight.

We have been writing about cases involving the Ohio Product Liability Act (“OPLA”) for a long time.  See, e.g.,  here , here, here, and here.  We have been litigating cases involving the OPLA even longer.  One of the main issues that used to come up was how the OPLA preempted common law. There was a period when the date that a case was filed affected what was and was not abrogated by the OPLA, which was certainly intended to provide a statutory framework for products liability claims under Ohio law, replete with limits on punitive damages and other protective provisions that a state with resident companies that manufactured products wanted. The common law, on the other hand, had been made by judges over the course of decades and tended to provide enough leeway for expansive applications of negligence and fraud in particular cases. In 2005, the OPLA was revised to make its abrogative effect clear, overruling a 1997 Ohio Supreme Court case. Old news, but it still keeps coming up.

Similarly, there are still new pelvic mesh cases being filed and, for a while now, most of the ones with diversity have not had to work their way through an MDL to get before a local federal court. Sylvester v. Ethicon, Inc., No. 1:19CV2658, 2020 U.S. Dist. LEXIS 47467 (N.D. Ohio. Mar. 19, 2020), is one such case. (From the information in the court’s opinion, it also looks to be old in the sense of time-barred, with a 2012 explant and a 2019 filing date.) It started out with a “standard” eighteen count (with fifteen claims plus loss of consortium, punitive damages, and an anti-SOL count) complaint asserting a variety of statutory and common law claims. For some reason, however, when it came time to oppose the motion for summary judgment on almost all of the counts, plaintiff decided to drop all but one of her claims under the OPLA and urge that her common law claims for negligence, fraud, and express warranty were viable. Because abrogation turns on the pleadings rather than the evidence adduced in discovery, this tactic turned the summary judgment analysis into a straight legal one.

The OPLA defines a “Product liability claim” as one that

that seeks to recover compensatory damages from a manufacturer or supplier for death, physical injury to person, emotional distress, or physical damage to property other than the product in question, that allegedly arose from any of the following:

(a) The design, formulation, production, construction, creation, assembly, rebuilding, testing, or marketing of that product;

(b) Any warning or instruction, or lack of warning or instruction, associated with that product;

(c) Any failure of that product to conform to any relevant representation or warranty.

Id.at **5-6 (quoting Ohio Rev. Code Ann. § 2307.71(A)(13)). Reviewing the multiple allegations that flowed into the four negligence-based counts and three fraud-based counts, it was apparent that they each hinged on several of these categories of conduct. The court patiently went through the allegations for these seven counts and dismissed each of them. Id. at **10-15.

Express warranty was a bit trickier because of the redundancy of plaintiff’s pleading. Plaintiff’s claims that “the pelvic mesh was not fit for use by consumers nor was it of merchantable quality” were covered by the plain language of subjection (c) above and, therefore, her common law claim for express warranty was abrogated. Id. at **12-13. However, the pleading was read as broad enough to allege a warranty claim under the Uniform Commercial Code, which is not abrogated (but does not allow personal injury damages). Id. at *13.

The last contested claim, unjust enrichment, was easier. Plaintiff alleged that she “did not receive the safe and effective medical devise [sic] for which [she] paid,” which “implicates the pelvic mesh’s failure to conform to a relevant representation and/or its marketing” under subjection (c). Id. at *5. Abrogation of this claim left plaintiff with one (unchallenged) claim under O.R.C. § 2307.75, which does not really provide a pure strict liability design defect remedy as set out in some of the posts linked above.

Today’s guest post is by Corinne Fierro, Mildred Segura, and Farah Tabibkhoei, all of Reed Smith.  These three are all part of the firm’s left-coast, techno side of the product liability practice, and bring our readers a recent appellate decision that addresses the intersection of 21st Century high technology and 20th Century product liability concepts.  As always, our guest bloggers deserve all the credit (and any blame) for what follows.

**********

Is an Artificial Intelligence (“AI”) algorithm subject to strict liability principles? For years, this question has gone unanswered by courts.  Now, it would seem that the courts’ long-awaited discussion on this topic has begun as T.S. Elliot predicted it all would end: “not with a bang but with a whimper.”

On March 5, 2020, the Court of Appeals for the Third Circuit held in Rodgers v. Christie that an algorithmic pretrial risk assessment, which uses a “multifactor risk estimation model,” to assess whether a criminal defendant should be released pending trial , was not a “product” under the New Jersey Products Liability Act (“NJPLA” or “the Act”).  2020 WL 1079233, at *2 (3d Cir. 2020).  This is not a life sciences case, but is important because it’s an indication of how the product liability framework may be applied to AI’s applications including, but not limited to, medical and pharmaceuticals.  You may recall this Blog’s past blog post, which theorized about how an AI product liability case could play out.  Although the Third Circuit’s Rodgers decision is not binding precedent, it is a start to what we believe will be a growing body of case law regarding AI in the product liability context.

Let’s dive in.

In Rodgers, Plaintiff brought a product liability action under the NJPLA after her son was murdered, allegedly by a man who had been granted pretrial release from jail just days earlier − after the state court used the Public Safety Assessment (“the PSA”).  Id. at **1-2.  The PSA is an algorithm developed by the Laura and John Arnold Foundation (the “Foundation”) to estimate a criminal defendant’s risk of fleeing or endangering the community.  Id. at *3.  Plaintiff sued the Foundation, and miscellaneous individuals not involved in this appeal.

The Court affirmed the district court’s dismissal of the complaint finding the PSA is not a product under the NJPLA.  The district court applied the NJPLA, which imposes strict liability on manufacturers or sellers of defective “products.”  Id. at *2.  The NJPLA does not define the term “product,” so the court turned to the Restatement (Third) of Torts.  Under the Restatement, a “product” is “tangible personal property distributed commercially for use or consumption” or any “[o]ther item[]” whose “context of . . . distribution and use is sufficiently analogous to [that] of tangible personal property.”  Id.

Applying this definition, the district court held the PSA does not qualify as a “product” under the Act, and therefore could not be subject to strict liability.  The Third Circuit affirmed this decision for two reasons: 1) the PSA is not distributed commercially; and 2) the PSA is not “tangible personal property nor remotely analogous to it.”  Id. at *3 (internal quotations removed).

As to the first point, the Third Circuit agreed with the district court that the PSA was not commercially distributed but rather designed as an “objective, standardized and . . . empirical risk assessment instrument” to be used in pretrial services programs.  Id. (internal quotations removed).

Second, the Third Circuit affirmed the district court’s reasoning that the PSA could not qualify as a “product” because “information, guidance, ideas, and recommendations” cannot be products under the Third Restatement.  Id. (internal quotations removed).

In addition to this definitional exclusion, the district court also was hesitant to impose strict liability because “extending strict liability to the distribution of ideas would raise serious First Amendment concerns.”  Id.  This reasoning, which has previously been applied to a variety of product liability cases involving books and media, could apply to AI more generally, given that AI algorithms are used most commonly now to render recommendations and guidance.  In healthcare, AI algorithms are used to diagnose patients with various diseases such as diabetic retinopathy and cancer.  They help patients monitor their health via “smart” insulin pumps and phone applications.  The role AI plays in these scenarios, however, is suggestive.  AI proposes its idea in the form of a diagnosis, or application alert, and human beings act upon that information.  The First Amendment defense would, by extension, likely apply to these algorithms.

Plaintiff attempted to sidestep the “product” definition, and argued that PSA’s defects “undermine[] New Jersey’s pretrial release system, making it not reasonably fit, suitable or safe for its intended use.”  Id. at *4 (internal quotations omitted).  The Third Circuit affirmed the lower’s court dismissal of this argument, noting that the NJPLA only applies to defective products, “not to anything that causes harm or fails to achieve its purpose.”  Id.

So what does this case mean for defendants facing AI product liability claims?  First, if the Third Circuit’s decision is any indication, courts are likely to apply traditional product liability principles to AI and find that AI is not a “product” within the meaning of the Restatement (Third) of Torts.  Second, courts following Rodgers are likely to hold that AI is not subject to strict liability claims.  Third, we expect the holding in Rodgers will not open the floodgates to AI litigation, for now, because plaintiffs will likely face an uphill battle in establishing that strict liability applies.  And finally, a First Amendment challenge stands in the way for plaintiffs seeking to extend strict liability to algorithms.

While this case is not binding precedent, it is hopefully the start of broader court engagement on the topic.  We’re hoping for a bang.