In re Zantac (Ranitidine) Products Liability Litigation

WILLIAM M. JANSSEN*

Why It Made the List

Robert Arthur was an acclaimed mystery writer when he was publishing during the 1930s, 1940s, and 1950s.[1] Among his more famous short stories was The Glass Bridge, published in 1957. It recounted the tale of a down-on-his-luck author who had grown old, ill, and forgotten. One day, a visitor came to blackmail him (we never learn why). She is seen trudging through two feet of snow up his front steps and entering his home, but is never seen leaving. The police, suspecting foul play, search the house and surrounding yard. But they come up empty, baffled that the deep, heavy snow encircling the home remained entirely undisturbed . . . except for that single set of footprints leading up to the front door. When questioned, the author (who could not have done any heavy lifting, given his heart condition) taunts the police, cackling that perhaps he killed the blackmailer and then whisked her away over some glass bridge, leaving no trace. The later, springtime discovery of the blackmailer’s body at the bottom of a pond down a valley deepens the mystery. Besides the body, the only clue is a white bedsheet from the author’s home, seen billowing in a tree nearby. The mystery re-kindles interest in the author and his book sales rebound. Until, that is, the mystery is finally solved—it is discovered that the author had drugged the blackmailer into unconsciousness, wrapped her in one of his spare bedsheets, sprayed the bundle with water until, in the freezing cold, it turned sled-like, which he then nudged over the edge of his back terrace. The frozen bundle slid swiftly down the steep hillside, leaving behind no indentation in the hardened snow, until it came to rest, a good distance later, down near the pond where, with the spring thaw, it sank. The author’s taunt, as it turns out, had previewed for the police precisely what he had done—he had used the frozen bedsheet to actually build a “glass bridge” to evade the law (albeit just momentarily).[2]

Like Robert Arthur’s “glass bridge,” the theory of “innovator liability” attempts the seemingly impossible: to hold a manufacturer liable for injuries caused by a product made, distributed, and sold by an entirely different company. More specifically, innovator liability proposes to demand compensation from the manufacturer of a branded pharmaceutical for injuries alleged to have been inflicted by a competitor—a generic manufacturer. As the last day of the pandemic year of 2020 was drawing to its close, the U.S. District Court for the Southern District of Florida issued its ruling in In re Zantac (Ranitidine) Products Liability Litigation.[3] This lengthy decision by the Honorable Robin L. Rosenberg examined innovator liability in a sweeping, multidistrict litigation (MDL) that sought damages under the laws of all fifty states, Puerto Rico, and the District of Columbia. The In re Zantac opinion ranks as one of the top food and drug cases of 2020 for three reasons.

First, it performed Erie prediction analyses to assess whether the following thirty-five jurisdictions would recognize the theory under either substantive products liability doctrine or general negligence principles: Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, District of Columbia, Hawaii, Illinois, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Utah, Vermont, Virginia, Wisconsin, and Wyoming.[4] The opinion predicted that the highest tribunal in each of those thirty-five jurisdictions, if presented with the question, would reject innovator liability both as a matter of products liability and under freeform negligence principles.

Second, these predictions concerned an anomaly in the federal pharmaceutical laws that, a decade ago, the U.S. Supreme Court had characterized as the “unfortunate hand” dealt generic medicine plaintiffs.[5] Unlike their counterparts injured by a branded pharmaceutical, conventional tort theory denies generic-consuming injured claimants the right to sue for most design or warning defects. Because In re Zantac may prove the impetus for a congressional rebalancing of the branded/generic pharmaceutical regulatory scheme, it could have far-reaching significance.

Third, the opinion also tested whether personal jurisdiction over defendants could exist for the MDL claimants in the only two states that allow innovator liability claims—California and Massachusetts—if those claims arose elsewhere. The opinion predicted that an exercise of personal jurisdiction in such circumstances would be improper.

Discussion

Zantac (ranitidine) was a “blockbuster” medicine, reportedly one of the first pharmaceuticals to reach $1 billion in annual U.S. sales. When it was approved by FDA in the early 1980s to treat heartburn and other gastric disorders, Zantac had already been in use in thirty-one other countries. By the late 1980s, it had become the best-selling drug in the world. In 1997, the patent held by brand manufacturer Glaxo expired and generic competitors entered the ranitidine market. Approval to sell without a prescription (over-the-counter or OTC) was granted in 2004.[6] As late as 2018, Zantac-brand and generic ranitidine still ranked forty-first on the list of drugs most used in the United States, with prescriptions estimated as approaching 19 million that year.[7] In 2019, it continued to appear in the WHO Model List of Essential Medicines.[8]

Although the medicine had been approved and on U.S. pharmacy shelves for more than thirty-five years,[9] new studies revealed that under certain circumstances, Zantac/ranitidine could break down and form N-nitrosodimethylamine (NDMA), a contaminant identified as a probable human carcinogen.[10] FDA first cautioned the public about this discovery, and later, following additional study, requested the voluntary removal of all Zantac/ranitidine products from the market.[11]

Litigation swelled. In February 2020, with fifteen civil actions pending in nine federal districts (six of which were putative class actions) and an additional 126 related actions pending in twenty-one districts, the Judicial Panel on Multidistrict Litigation directed MDL treatment for the mounting inventory of Zantac/ranitidine personal injury lawsuits.[12] Plaintiffs’ counsel proposed ten possible federal districts for transfer, ultimately “coalesc[ing]” on the Southern District of Florida; defendants’ counsel proposed either New York or New Jersey as the transferee district.[13] The Panel settled on the plaintiffs’ recommendation and ordered the transfers to the Southern District of Florida.[14] Soon, hundreds of civil actions arrived to Judge Rosenberg’s chambers; thousands of other unfiled claimants “registered” their intended claims.[15]

The brand manufacturer defendants filed motions to dismiss on two grounds. First, they challenged whether the innovator liability claims of generic consumers could survive a Rule 12(b)(6) motion to dismiss because, they argued, no such claims are legally cognizable outside of California or Massachusetts. Second, they challenged whether California-based and Massachusetts-based claims could survive a Rule 12(b)(2) personal jurisdiction challenge if those claims had not arisen out of defendants’ contacts with either of those states. Judge Rosenberg granted the motions in defendants’ favor on both grounds.

First Challenge: Rule 12(b)(6)—Failure to State a Claim

The highest courts of the thirty-five In re Zantac jurisdictions had not yet answered the question plaintiffs posed—can a manufacturer of a brand pharmaceutical be liable to a consumer injured by the generic version of that product (i.e., a version the defendant brand manufacturer did not make, distribute, or sell)? Plaintiffs contended that brand manufacturers should, on negligence principles. Their innovator liability theory reasoned that the brand manufacturers made misrepresentations regarding the safety of their brand drug, that brand drug in turn created a foreseeable market for generic copies, the existence of generic-ingesting consumers was thus necessarily foreseeable, and those consumers’ post-ingestion injuries were therefore foreseeable consequences of the brand manufacturer misrepresentations. Accordingly, theorized plaintiffs, the brand manufacturers owed, and breached, a foreseeable duty of care to generic consumers, for which those manufacturers could be liable in tort.[16]

Judge Rosenberg’s first task was to calibrate her Erie prediction inquiry. As a federal judge presiding over a bundle of diversity-based lawsuits, the redoubtable Erie Railroad Co. v. Tompkins[17] obligated her to apply state law. Thus, where the highest court of that state has spoken on a contested point of law, a federal judge is bound to apply their precedent.[18] Where, however, there is no on-point high court pronouncement or applicable state statute, the federal court’s chore remains just the same—to apply state law; only this time, the federal judge must discern the content of that law from other sources.[19] Though not reflexively binding, decisions of intermediate state courts on the disputed question should be followed “in the absence of more convincing evidence of what the state law is.”[20] The approach to Erie predictions taken by the United States Court of Appeals for the Eleventh Circuit (the controlling circuit precedent for the Southern District of Florida) added two final wrinkles to this journey. First, federal judges are counseled that states are “generally presume[d]” likely to “adopt the majority view on a legal issue in the absence of indications to the contrary.”[21] And, second, when invited to adopt a cause of action the state has not itself yet accepted, federal judges are advised by “considerations of comity and federalism” to “proceed gingerly.”[22]

Armed now with this Erie methodology, Judge Rosenberg turned to her task. She began by citing the Eleventh Circuit’s conclusion that “the overwhelming national consensus—including the decisions of every court of appeal and the vast majority of district courts around the country to consider the question—is that a brand-name manufacturer cannot be liable for injuries caused by the ingestion of the generic form of a product.”[23] This “mountain of authority” would therefore require an impressively convincing basis for predicting that any state would rule otherwise. And Judge Rosenberg found none, after examining the law in the thirty-five jurisdictions.

First, to the extent plaintiffs’ Zantac/ranitidine claims were (or had to be) construed as products liability actions, Judge Rosenberg found no room for innovator liability; each of the thirty-five jurisdictions imposed what she labeled as the “product identification” requirement—”for a plaintiff’s claim to survive [as a products liability action], the plaintiff must allege that she was injured by the defendant’s product.”[24] This necessarily ended the inquiry. Generic consumers could neither allege nor prove that they were injured by the brand manufacturer’s product because the medicine they ingested was made by someone else.

Second, likely anticipating this dead-end, plaintiffs had insisted their claims were not products liability actions at all but instead sounded under general, freeform negligence principles. This, too, proved unsuccessful. Judge Rosenberg determined that some of the thirty-five jurisdictions would allow no such general negligence distinction; in those states, all negligence-grounded claims concerning a product injury are construed as products liability actions—all subject to the same, dooming “product identification” requirement. In those other jurisdictions that would or might recognize a general, freeform negligence distinction, Judge Rosenberg predicted they would all reject a negligence-based innovator liability theory, given the formidable national majority hostile to that theory and “the absence of any strong evidence that these jurisdictions would join the minority view.”[25] Jurisdiction by jurisdiction, Judge Rosenberg surveyed each state’s foreseeability requirement for its negligence tort and then found that the absence of a relationship between the claimants and the brand manufacturers, the policy considerations that weighed heavily against innovator liability, and the fact that the generic consumers’ injuries were the foreseeable result of laws over which the brand manufacturers had no control, all counseled against recognizing this novel liability theory.[26] Thus ended the generic MDL plaintiffs’ putative claims against brand manufacturer defendants . . . in all states but California and Massachusetts.

Second Challenge:

Rule 12(b)(2)—Lack of Personal Jurisdiction

The highest courts in California and Massachusetts had imported innovator liability theory into their common law in 2017 and 2018, respectively.[27] Because the brand manufacturers all had affiliating business contacts with those states, the generic consumer plaintiffs next posited that all their claims could be litigated there, regardless of where those plaintiffs resided, bought and ingested their medicine, or suffered injury. Defendants resisted this contention as mired in a misunderstanding of constitutional personal jurisdiction law. Judge Rosenberg agreed.

The constitutionalization of personal jurisdiction was recognized in 1878 in Pennoyer v. Neff. Back then, constitutional fitness for in personam civil actions hinged on either of two attributes: the defendant’s service in-state with process or the defendant’s voluntary appearance.[28] By the second decade of the 21^st Century, that begrudging constitutional reach had been relaxed significantly, though a meaningful constitutional restraint still remained. Today, in addition to in-state service and voluntary appearance, defendants can also be sued civilly in any forum where they are “essentially at home” (i.e., general jurisdiction) or where their purposeful acts give rise to or relate to the cause in suit (i.e., specific jurisdiction).[29]

Since Judge Rosenberg was not confronted in In re Zantac by any in-state service or consent-based personal jurisdiction claim, her focus rested solely with general and specific jurisdiction. The U.S. Supreme Court had ruled that general (or “all-purpose”) personal jurisdiction over a corporate defendant ordinarily exists only where that defendant is incorporated or maintains its principal place of business.[30] Plaintiffs conceded as much, leading Judge Rosenberg to rule that the brand defendants were amenable to general jurisdiction only in their respective states of incorporation and principal place of business (which, for most of those defendants, were not California or Massachusetts).[31] So, Judge Rosenberg moved on.

Specific (or “conduct-linked”) jurisdiction exists where a defendant, who has purposefully availed itself of the privilege of conducting activities in a certain forum, is being sued in that same forum on a cause of action that arises from or relates to its activities there.[32] The fact that a defendant has engaged in other significant, ongoing activities in a particular forum—even activities related to the very same product that injured different litigants elsewhere—is not alone enough to confer specific personal jurisdiction; the claims of each putative plaintiff must have arisen from or related to the defendant’s in-forum activities.[33] If they do not, specific jurisdiction is foreclosed.

Here, too, Judge Rosenberg was guided by Circuit precedent. In the Eleventh Circuit, the Court of Appeals had ruled, “a tort ‘arise[s] out of or relate[s] to’ the defendant’s activity in a state only if the activity is a ‘but-for’ cause of the tort.”[34] Because the burden of establishing a court’s personal jurisdiction lies with the party invoking it, the plaintiffs had the obligation to set out the “specific, non-conclusory facts” necessary to support personal jurisdiction. This, ruled Judge Rosenberg, they had failed to do. First, plaintiffs had not adequately alleged that the brand defendants’ in-forum activities in any state were the “but-for” cause of their ingestion of generic ranitidine and resulting injuries. Second, plaintiffs had also not adequately alleged that the defendants should have foreseen that their in-forum, brand-related activities in those states could expose them to liability for the injuries suffered by consumers of the generic medicine.[35] For this reason, personal jurisdiction over any claims by any generic consumers outside of the brand defendants’ home states was improper.[36]

Impact

When the West Virginia Supreme Court refused the invitation to import innovator liability into its common law a few years ago (one of the FDLI Top Cases of 2018),[37] the national trend-line on the vitality of this theory was still forming. As time has passed, the theory’s reception by America’s courts has chilled decidedly. If the Eleventh Circuit Court of Appeals affirms Judge Rosenberg’s Erie survey of the country’s jurisdictions, and if her predictions are later borne out as high court after high court finally passes on the question, the result will be a textbook example of a nation divided: two U.S. states allowing an unconventional compensation theory that nearly the rest of the country will have rejected. And because this divide is anchored in state law, a unifying resolution from the U.S. Supreme Court is improbable.

Why is a solution to generic product injuries so exasperatingly elusive?

Most state law failure-to-warn claims asserted against generic manufacturers are preempted because those manufacturers lack discretion on what that warning can say.[38] Likewise, most state law design defect claims against generic manufacturers are preempted because those manufacturers lack discretion to change the composition of the product.[39] Thus, absent a mistakenly printed warning label or a bad-batch manufacturing error, consumers claiming injury from generic medicines are ordinarily afforded no product liability recourse at all—while a similarly injured consumer who purchased the brand medication (the one the generic replicates) possesses state law compensation options. This asymmetrical justice is all the more curious when one considers that script-filling pharmacists may (and, under some regulatory regimes, must) fill their customers’ prescriptions by substituting the generic version of a medicine for the brand version their doctors ordered.[40]

Not to worry, consumers have long been reassured, this conundrum will cause them trouble rarely, if ever. Brand manufacturers ordinarily enjoy years of patent-protected exclusivity (i.e., no generic competitors) in selling their medicines, and FDA reports that “genuinely new information about drugs in long use (as generic drugs typically are) appears infrequently.”[41] So, the risk of a long-undiscovered pharmaceutical defect posing a surprising new risk to some generic consumer is unlikely.

But Zantac was just such an “in-long-use” medicine. And FDA requested its removal from the market because of a new risk discovered more than thirty years after the drug was first approved. Ergo, latently unearthed risks to generic consumers may be unlikely, but they are certainly not unprecedented. Innovator liability proposed an unusual, common law solution to this vexing asymmetry. Yet, for sound analytical and policy reasons, that solution proved to be (in the view of most courts) as intractably unjust as the problem it endeavored to solve. After all, the arrival of generic competition is not, as a rule, a welcome development to brand manufacturers. To the obvious contrary, generics hollow out the market with comparatively inexpensive substitutes to replace the original branded product—precisely as the Hatch-Waxman Act intended. So, absent a patentable enhancement to the branded product, the arrival of generic competition signals the collapse of the branded product’s market. To this end-of-product-life tale, innovator liability proposed to add a startling epilogue—uncontainable liability for harm caused to some other company’s customers by a product the brand manufacturer has not made, distributed, sold, or profited from. And that liability could go on for years (or forever).

When Justice Traynor first introduced strict products liability into California common law, he explained why that evolution in the law was just: “Implicit in [a product’s] presence on the market . . . was a representation that it would safely do the jobs for which it was built.”[42] In many ways, this was the birth of modern products liability doctrine, one liberated from the technicalities of written promises, warranties, and commercial sales. Today, Traynor’s equation seems to many the very epitome of fairness: if one offers something for sale to another, that seller—having profited from the sale it induced—owes an obligation to ensure what it sold is safe for what it was sold to do. It is hard to imagine a tort theorist, even one from Traynor’s halcyon days of legal inventiveness, surmising that product liability could, in any form, ever be de-linked from the injury-causing product. Yet that is precisely what innovator liability proposes. It offers a “glass bridge” of sorts, built to leap over and past settled and sound principles of products liability law. And that is precisely why it has so often failed.

The path to a remedy for injured generic consumers was narrowed further by the U.S. Supreme Court’s recent sharpening of the boundaries between general and specific personal jurisdiction. Earlier, injured generic consumers might well have been prepared to decamp to California or Massachusetts to litigate an innovator liability claim, but recent personal jurisdiction case law now often foreclose that option. If a patient sees her doctor in State X, is prescribed a medicine in State X, has that prescription filled with a generic medicine in State X, ingests that medicine in State X, and suffers a resulting injury in State X, then that patient cannot litigate an innovator liability claim in a different state (say, California or Massachusetts) unless the brand manufacturer is incorporated or headquartered there or designed or manufactured the product there (something fewer and fewer brand manufacturers are now likely to do).

Judge Rosenberg’s decision was handed down three months before the U.S. Supreme Court released its long anticipated ruling in late March 2021 in Ford Motor Co. v. Montana Eighth Judicial District Court.[43] That opinion will force a revisiting of the Eleventh Circuit “but-for” precedent on which she relied, but likely not in a way that impacts the outcome in In re Zantac. In Ford Motor Co., the Supreme Court gave content, for the first time, to the second half of the “arises from or relates to” test, ruling that specific personal jurisdiction does not always depend on proof of a causal link between a defendant’s in-forum activities and an injured plaintiff’s cause of action. Instead, specific personal jurisdiction may also exist in a forum where a plaintiff resides and suffers personal injury (even if the defendant’s product was not sold to the injured plaintiff there, manufactured there, or designed there)—if the defendant has purposefully availed itself of the privilege of marketing, selling, and servicing the very same product in that forum.[44] But the Court seemed quite insistent in its new Ford Motor Co. decision on keeping tightly shut a forum’s doors to those claimants injured and residing elsewhere, and that result portends the same unfavorable outcome for the In re Zantac plaintiffs.[45]

While the predictive holdings in In re Zantac may be both principled and sound, they leave the troubling generic customer asymmetry dilemma unresolved. Given the current formulation of the Hatch-Waxman regime, a common law fix may well be beyond the reach of the judiciary—at least not without ushering in all manner of unintended unhappy consequences. On that score, Justice Thomas offered a fitting, closing thought when he wrote that it is not the judiciary’s task—

to decide whether the statutory scheme established by Congress is unusual or even bizarre . . . . Indeed, it is the special, and different, regulation of generic drugs that allowed the generic drug market to expand, bringing more drugs more quickly and cheaply to the public. But different federal statutes and regulations may, as here, lead to different pre-emption results . . . . As always, Congress and the FDA retain the authority to change the law and regulations if they so desire.[46]

Perhaps In re Zantac will trigger just such a fresh look.

 

*    William M. Janssen is a professor of law at the Charleston School of Law in Charleston, South Carolina, where he teaches products liability, mass torts, civil procedure, and constitutional law.

[1]    See Biography—Robert Arthur, Jr., http://www.elizabetharthur.org/bio/rarthur.html (last visited Mar. 22, 2021).

[2]    Robert Arthur, Jr., The Glass Bridge, in Alfred Hitchcock’s Mystery Magazine (July 1957).

[3]    __ F. Supp. 3d __, 2020 WL 7866660 (S.D. Fla. Dec. 31, 2020), appeals pending, Nos. 21-10305, 21-10307, & 21-10335 (11th Cir.).

[4]    For those keeping score, the remaining seventeen American jurisdictions were not addressed in the In re Zantac opinion for different reasons: defendants had conceded that two states (California and Massachusetts) had already recognized innovator liability; plaintiffs had conceded that four states (Alabama, Florida, Iowa, and West Virginia) had already rejected innovator liability; and plaintiffs had advised the court that they were not pursuing claims in eleven states (Georgia, Idaho, Indiana, Kansas, Kentucky, Louisiana, New Jersey, Ohio, Tennessee, Texas, and Washington). See id. at *4 n.5.

[5]    PLIVA, Inc. v. Mensing, 564 U.S. 604, 625 (2011).

[6]    See generally In re Zantac, 2020 WL 7866660, at *1; Timeline: Popular Heartburn Medicine Zantac Pulled Off Store Shelves, Reuters—Healthcare & Pharma (Oct. 21, 2019), https://www.reuters.com/‌article/us-health-fda-heartburn-timeline/timeline-popular-heartburn-medicine-zantac-pulled-off-store-shelves-idUSKBN1X014E (last visited Mar. 21, 2021).

[7]    See Ranitidine—Drug Usage Statistics, United States, 2008–2018, ClinCalc.com, https://clincalc.com/‌DrugStats/Drugs/Ranitidine (last visited Mar. 21, 2021).

[8]    See World Health Organization, Model List of Essential Medicines at § 17.1 (2019).

[9]    See U.S. Food & Drug Admin., Why Didn’t FDA Catch This Impurity When The Product Was Initially Approved?, Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac) (Apr. 1, 2020), https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-ndma-impurities-ranitidine-commonly-known-zantac (last visited Mar. 21, 2021) (“Drug manufacturers and FDA continually gain new knowledge about drugs, which is why FDA constantly evaluates quality and safety information over time. As testing methods have become more sophisticated and sensitive, FDA and industry can identify and mitigate previously-unknown risks to patients.”).

[10]  See U.S Food & Drug Admin., FDA Requests Removal of All Ranitidine Products (Zantac) from the Market: FDA Advises Consumers, Patients, and Health Care Professionals After New FDA Studies Show Risk to Public Health, FDA News Release (Apr. 1, 2020) (available at https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market) (last visited Mar. 21, 2021).

[11]  See id. See also Lior Z. Braunstein, Elizabeth B. Kantor, Kelli O’Connell, Amber Jessop Hudspeth, Qian Wu, Nicola Zenzola & David Y. Light, Analysis of Ranitidine-Associated N-Nitrosodimethylamine Production Under Simulated Physiologic Conditions, JAMA Network Open, Jan. 29, 2021, https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2775727 (last visited Mar. 21, 2021) (“[U]nder simulated gastric conditions, NDMA yield from a standard tablet of ranitidine was seen to increase with both increasing nitrite and decreasing pH to levels up to 3 orders of magnitude beyond established limits. . . . Although additional studies are ongoing, these data support recent regulatory actions to limit ranitidine availability.”).

[12]  In re Zantac (Ranitidine) Prods. Liab. Litig., 437 F. Supp. 3d 1368 (J.P.M.L. 2020) (forming MDL No. 2924).

[13]  Id. at 1369.

[14]  Id. at 1369–70 (noting the “large number” of Zantac actions already pending in S.D. Fla., that district’s relative convenience and accessibility “with the resources and the capacity to efficiently handle what could be a large litigation,” and also that centralization before Judge Rosenberg “allows us to assign this litigation to an able jurist who has not yet had the opportunity to preside over an MDL” whom, “[w]e are confident . . . will steer this litigation on an efficient and prudent course”).

[15]  See In re Zantac, 2020 WL 7866660, at *2.

[16]  See id. at *3.

[17]  304 U.S. 64, 78 (1938) (“Except in matters governed by the Federal Constitution or by Acts of Congress, the law to be applied in any case is the law of the State.”).

[18]  See Comm’r v. Bosch’s Est., 387 U.S. 456, 465 (1967) (“state law as announced by the highest court of the State is to be followed [because, when] the underlying substantive rule involved is based on state law[,] . . . the State’s highest court is the best authority on its own law”).

[19]  See Fidelity Union Tr. Co. v. Field, 311 U.S. 169, 177 (1940) (“but it is still the duty of the federal courts, where the state law supplies the rule of decision, to ascertain and apply that law even though it has not been expounded by the highest court of the State”) (footnote omitted).

[20]  See id. at 177–78. See also King v. Order of United Commercial Travelers, 333 U.S. 153, 160–61 (1948); West v. American Tel. & Tel. Co., 311 U.S. 223, 237 (1940).

[21]  See Bobo v. Tennessee Valley Auth., 855 F.3d 1294, 1304–07 (11th Cir. 2017) (noting approach, but finding convincing “indications” that the Alabama Supreme Court would follow a minority view on a duty question).

[22]  Guarino v. Wyeth, LLC, 719 F.3d 1245, 1251 (11th Cir. 2013). See also Douglas Asphalt Co. v. QORE, Inc., 657 F.3d 1146, 1154 (11th Cir. 2011) (“It is not the function of federal courts to expand state tort doctrine in novel directions absent state authority suggesting the propriety of doing so.”).

[23]  Guarino, 719 F.3d at 1252–53.

[24]  See In re Zantac, 2020 WL 7866660, at *7. See also id. Appendix A at *12–*39.

[25]  See id. at *8. See also id. Appendix A at *12–*39.

[26]  See id. Appendix A at *12–*39.

[27]  See T.H. v. Novartis Pharm. Corp., 407 P.3d 18 (Cal. 2017); Rafferty v. Merck & Co., 92 N.E.3d 1205 (2018).

[28]  See Pennoyer v. Neff, 95 U.S. 714, 733 (1878) (holding that the validity of a state’s judgments “may be directly questioned, and their enforcement in the State resisted, on the ground that proceedings in a court of justice to determine the personal rights and obligations of parties over whom that court has no jurisdiction do not constitute due process of law”).

[29]  See Ford Motor Co. v. Montana Eighth Jud. Dist. Ct., 141 S. Ct. 1017, 1024–25 (2021) (discussing differing standards for general (“all-purpose”) jurisdiction and specific (“conduct-linked”) jurisdiction); Daimler AG v. Bauman, 571 U.S. 117, 121–34 (2014) (same).

[30]  See Goodyear Dunlop Tires Ops., S.A. v. Brown, 564 U.S. 915, 919 (2011). See also Daimler, 571 U.S. at 139 n.20 (“A corporation that operates in many places can scarcely be deemed at home in all of them.”). Cf. BNSF Ry. Co. v. Tyrrell, 137 S. Ct. 1549, 1558–59 (2017) (acknowledging the possibility of an “exceptional case” where general jurisdiction might exist elsewhere, yet holding that hammering more than 2,000 miles of permanent railroad track into the Montana earth and engaging more than 2,000 employees in Montana would not qualify).

[31]  See In re Zantac, 2020 WL 7866660, at *10–*12.

[32]  See Ford Motor Co., 141 S. Ct. at 1024–25; Bristol-Myers Squibb Co. v. Superior Ct., 137 S. Ct. 1773, 1780 (2017).

[33]  See id. at 1781 (in pharmaceutical case brought by injured Californians, rejecting the exercise of specific jurisdiction in California over similar claims asserted by similarly situated plaintiffs but who were injured outside California: “What is needed—and what is missing here—is a connection between the forum and the specific claims at issue.”).

[34]  Waite v. All Acquisition Corp., 901 F.3d 1307, 1314 (11th Cir. 2018) (citation omitted).

[35]  See In re Zantac, 2020 WL 7866660, at *10–*11.

[36]  For the same reason that their personal jurisdiction averments failed to meet constitutional prerequisites, plaintiffs’ attempt to invoke “legislative jurisdiction” (the borrowing by the brand defendants’ home states of the innovator liability theory adopted by California and Massachusetts) also failed. See id. at *11–*12.

[37]  See McNair v. Johnson & Johnson, 818 S.E.2d 852 (W. Va. 2018) (discussed in McNair v. Johnson & Johnson, Top Food and Drug Cases, 2018, & Cases to Watch, 2019, at 14 (August T. Horvath, ed., 2019)).

[38]  See PLIVA, Inc. v. Mensing, 564 U.S. 604, 618 (2011) (“Federal law . . . demanded that generic drug labels be the same at all times as the corresponding brand-name drug labels. Thus, it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal-law duty to keep the label the same.”).

[39]  See Mutual Pharm. Co. v. Bartlett, 570 U.S. 472, 483–84 (2013) (“[T]he FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as the brand-name drug on which it is based. Consequently, . . . ‘Mutual cannot legally make sulindac in another composition.’”).

[40]  See PLIVA, Inc., 564 U.S. at 625.

[41]  See id. at 625 n.9.

[42]  See Greenman v. Yuba Power Prod., Inc., 377 P.2d 897, 901 (Cal. 1963).

[43]  141 S. Ct. 1017 (Mar. 25, 2021).

[44]  See id. at 1026–32.

[45]  See id. at 1027 n.3 (rejecting view that state courts should have jurisdiction over a national company on any claim, regardless of relatedness: “On that view, for example, a California court could hear a claim against Ford brought by an Ohio plaintiff based on an accident occurring in Ohio involving a car purchased in Ohio. . . . ‘Case-linked’ jurisdiction would then become not case-linked at all.”) (citation omitted).

[46]  See PLIVA, Inc., 564 U.S. at 625–26 (cleaned up).