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Drug / Device Law Blog Legal updates, news, and commentary from the attorneys of Baker Sterchi Cowden & Rice LLC

"Impossibility Preemption" Remains Alive and Well in Missouri for Generic Drug Manufacturers

April 6, 2018 | Leigh Ann Massey

“Impossibility preemption” applies to bar tort claims where it is impossible for a party to comply with both state and federal law. In the recent opinion of Raskas v. Teva Pharms. USA, Inc., No. 4:17-CV-2261 RLW, 2018 U.S. Dist. LEXIS 3507 (E.D. Mo. January 8, 2018), the Eastern District of Missouri reaffirmed application of “impossibility preemption” to generic drug manufacturers  on strict liability and negligent defective design and failure to warn claims. 

The allegations in the Raskas v. Teva complaint provide the story of a young man, Ralph Raskas, who, after seeking treatment for nausea and vomiting, ingested the medication prescribed by his physician - generic metoclopramide - and allegedly developed pain and restlessness in his legs. After being diagnosed with “drug-induced acute akathisia,” he complained of significant pain and eventually committed suicide after two prior attempts.  His father filed a wrongful death action against Teva Pharmaceuticals, USA (Teva) and Actavis Elizabeth, LLC (Actavis) - manufacturers of the dispensed generic metoclopramide - alleging that the drug caused his son’s neurological injuries and suicide. Plaintiff asserted claims for strict liability and negligent defective design and failure to warn, negligence in identifying risks associated with the drug, as well as what he contended was a failure to update the generic medication’s labeling to conform to that of its brand name equivalent. Relying upon PLIVA, Inc. v. Mensing, 564 U.S. 608 (2011), and Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013), Teva and Actavis sought dismissal of all claims against them on federal preemption grounds. 

The Raskas court began its analysis of the plaintiff’s claims by reviewing the approval requirements of the Food and Drug Administration (FDA) for both brand name and generic drugs. To gain approval of brand name drugs, a manufacturer must submit a new-drug application (NDA) that includes clinical investigative reports and all relevant information to allow the agency to determine whether the drug is safe for use. On the other hand, approval of a generic drug typically requires only that the generic be “bioequivalent” to the branded medication. In fact, a generic may receive FDA approval without any in vivo studies, solely based on in vitro studies that study dissolution of the proposed generic.  See 21 C.F.R. §§ 320.24(b)(5) and 320.22(d)(3).

Critically for the generic drug manufacturers in Raskas, 21 C.F.R. Part 314 prohibits generic drug manufacturers from 1) making any unilateral changes to a drug’s label, and 2) deviating from the drug’s approved formulation. See 21 21 C.F.R. §§ 314.94(a)(8)(iii), 314.150(b)(10), and 314.70(b)(2)(i). These federal regulatory restrictions are the basis for the “impossibility preemption” found in Raskas.

In rejecting the plaintiff’s defective design claims, the court considered Brinkley v. Pfizer, Inc., 772 F.3d 1133 (8th Cir. 2014), in which metoclopramide design defect claims were specifically precluded due to preemption because the only way the manufacturer could avoid liability under Missouri law was by redesigning the product. If a generic drug manufacturer were required to redesign the product to comply with Missouri state law, it would be impossible to comply with federal law, which requires a generic drug’s formulation to be bioequivalent to the branded medication and the generic’s labeling to be identical to that of the brand name drug. This is the definition, and a descriptive example, of impossibility preemption, which provides that “[w]here state and federal law directly conflict, state law must give way.” Mensing, 564 U.S. at 617. 

Raskas’s failure to warn claims were found to be similarly barred by impossibility preemption, because the warning labels on the generic metoclopramide manufactured by Teva and Actavis were required, under 21 C.F.R. Part 314, to be identical to those of the brand name medication Reglan®. If the failure to warn claims were allowed to proceed, generic drug manufacturers - in order to escape state tort liability - would be required to relabel their products to provide additional information or warnings, which is directly prohibited under federal regulations. The Missouri federal district court in Raskas determined it would be impossible for Teva and Actavis to comply with both state and federal law in this instance, so dismissal of the failure to warn claims against them was appropriate. 

Although the plaintiff attempted to distinguish its claims from those presented in controlling legal precedent, the court ultimately concluded that impossibility preemption applied to each of the asserted negligence, strict liability, and wrongful death claims for failure to warn or defective design. The plaintiff was, however, granted leave to amend his complaint to adequately plead an alleged claim against Teva and Actavis for failure to update their labeling to conform to that of Reglan®, the brand name medication.

The Raskas opinion may be found here in its entirety.

Breaking Up [Plaintiffs] Is [Not] Hard To Do

March 28, 2018 | Megan Sterchi Lammert

While Neil Sedaka may have convinced many that breaking up is hard to do, Judge Stephen N. Limbaugh, Jr. of the United States District Court for the Eastern District of Missouri (“EDMO”) has made it clear that breaking up non-Missouri related Plaintiffs from a product liability case is certainly not hard to do in the post-Bristol-Myers Squibb Co. era.

On January 24, 2018, the EDMO added to the split in authority between Missouri and California, two forums favored by Plaintiffs, thereby testing the limits of Bristol-Myers Squibb Co. v. Super Ct. of Cal., 137 S. Ct. 1772 (2017) (“BMS”).In Nedra Dyson, et al., v. Bayer Corporation, et al., No. 4:17CV2584- SNLJ, (E.D. MO Jan. 24, 2018) (“Dyson”), Judge Limbaugh of the EDMO granted Defendants’ Motion to Dismiss 92 non-Missouri related Plaintiffs in a product liability lawsuit based on a lack of personal jurisdiction, finding that a Defendant’s clinical trials and marketing of a product in the state of Missouri does not establish personal jurisdiction for purposes of non-Missouri related Plaintiffs’ claims for that product. This is consistent with other recent EDMO decisions:

  • See Siegfried v. Boehringer Ingelheim Pharmaceuticals, Inc., 2017 WL 2778107 (E.D. Mo. June 27, 2017);
  • Jordan v. Bayer Corp., No. 4:17cv865(CEJ), 2017 WL 3006993 (E.D. Mo. July 14, 2017);
  • Jinright v. Johnson & Johnson, Inc., 2017 WL 3731317 (E.D. Mo. Aug. 30, 2017);
  • Shaeffer et al., v. Bayer Corp., et al., 4:17-CV-01973 JAR (E.D. Mo. Feb. 21, 2018).

The Dyson Defendants, who were also not citizens of Missouri, relied on BMS to argue that the EDMO lacked personal jurisdiction over the claims of 92 non-Missouri related Plaintiffs, and should be dismissed. The Defendants argued that dismissal of these Plaintiffs would provide complete diversity between the remaining Plaintiffs and Defendants and the amount in controversy would still exceed $75,000. This quickly became a fight between the parties, with one side trying to persuade the court to decide personal jurisdiction before subject matter jurisdiction and the other side arguing vice-versa. Ultimately, the court determined that personal jurisdiction could and should be decided prior to subject matter jurisdiction, because it provided the more straightforward analysis in light of BMS. Deciding subject matter jurisdiction would involve resolution of notoriously complex issues, reasoned the court.

Quick Recap On BMS: As a brief refresher, BMS involved both California and out of state Plaintiffs who sued in California state court based on alleged injuries caused by Defendant BMS’ drug. The United States Supreme Court, who took the case on a writ of certiorari, overturned the state court, applying “settled principles regarding specific jurisdiction,” finding that California state courts fail to retain specific personal jurisdiction over non-resident Defendants for claims asserted by non-resident Plaintiffs that do not arise out of or relate to the Defendant’s contacts with the forum. The Court rejected Plaintiffs arguments for specific personal jurisdiction based on alleged marketing and promotion of the product and clinical trials held in the state of California. The Court would also not allow the resident Plaintiffs’ allegations to confer personal jurisdiction over the non-resident Plaintiffs claims. Therefore, the Supreme Court dismissed the claims of the non-resident Plaintiffs.

In Dyson, the non-Missouri related Plaintiffs conceded that the medical device at issue (Essure) was not implanted in Missouri. However, Plaintiffs argued that their allegations concerning Defendant Bayer’s connections with Missouri should support the court’s exercise of personal jurisdiction. Plaintiffs alleged that Bayer’s marketing strategy was developed in Missouri, Missouri was one of the eight sites chosen to conduct pre-market clinical devices on the product (Essure), the original manufacture of the product’s conduct was in Missouri, the sponsoring of biased medical trials was in Missouri, and St. Louis, Missouri was the first city to commercially offer the Essure implant procedure. 

Those arguments failed to persuade Judge Limbaugh, who ultimately found that the Dyson Plaintiffs failed to make a prima facie showing for personal jurisdiction and, as such, he denied their motion for jurisdictional discovery to support those arguments. Relying on BMS, Judge Limbaugh rejected Plaintiffs’ marketing campaign arguments, pointing out that the non-Missouri Plaintiffs not only failed to allege they viewed Essure advertising in Missouri, but also failed to allege they purchased, were prescribed or were injured by the product in Missouri. Thus, it was not relevant that Defendant first marketed Essure in Missouri. As for Plaintiffs’ argument regarding clinical trials in Missouri, Judge Limbaugh found such alleged conduct too attenuated to serve as a basis for specific personal jurisdiction over Defendants. In fact, the non-Missouri Plaintiffs failed to allege they even participated in a Missouri clinical study or that they reviewed and relied on the Missouri clinical studies in deciding to use the products.

In contrast to Dyson, Plaintiffs have tried to rely on the recent California case Dubose v. Bristol-Myers Squibb Co., No. 17-cv-00244, 2017 U.S. Dist. LEXIS 99504 (N.D. Cal. June 27, 2017) in support of specific personal jurisdiction over non-forum Defendants. Dubose, however, does not appear to employ the same analysis as BMS or its progeny.

In Dubose, a South Carolina resident Plaintiff sued AstraZeneca, Bristol-Myers Squibb, and McKesson in California federal court, alleging a defect in a prescription diabetes drug.  The Dubose court relied upon Walden v. Fiore, 134 S.Ct. 1115 (2014), a 2014 U.S. Supreme Court decision that was in fact a pro-Defendant ruling intended to limit the states’ exercise of personal jurisdiction over non-resident Defendants. The Dubose Court reasoned that because Walden stressed that only the Defendants’ conduct could justify exercise of personal jurisdiction, any jurisdictional analysis should ignore Plaintiff’s residence or place of injury, and focus instead upon conduct that might “tether” the Defendant to the forum state. Ultimately, the Court relied on the Ninth Circuit’s preexisting “but for” test, holding that the pre-approval clinical trials were “part of an unbroken chain of events leading to Plaintiff’s alleged injury” and, therefore, specific jurisdiction existed because Plaintiff’s injuries “would not have occurred but for [Defendants] contacts with California.” Regardless, the Dubose Court ultimately transferred the case to South Carolina, the Plaintiff’s home state.

The judge in Dubose also decided Cortina v. Bristol-Myers Squibb Co., No. 17-cv-00247-JST, 2017 U.S. Dist. LEXIS 100437 (N.D. Cal. June 27, 2017) on the same theories, denying a motion to dismiss but transferring the case to New York, where the Plaintiff was a resident and was prescribed the drug at issue.  However, in a footnote, the Cortina court noted that, “[it] does not mean to suggest that even a de minimis level of clinical trial activity would satisfy the requirements of specific jurisdiction.”   

While the holdings for the Dubose and Cortina case appear to have relied upon attenuated claims of specific personal jurisdiction, in the EDMO, Judge Limbaugh concluded that the Dyson non-Missouri Plaintiffs’ claims were too attenuated from Missouri to prove specific, case linked personal jurisdiction. For example, the Dubose Plaintiff did not allege that she participated in any of the Defendants’ California clinical trials, but the Dubose court relied on others, not a party to the case, who participated in them. If specific personal jurisdiction exists in every state where a clinical trial occurred, then any Plaintiff who used the subject drug conceivably could sue the manufacturer in any of those states—no matter where the manufacturer is based and no matter where the Plaintiff resides or used the drug. It would be illogical for courts to adopt this rationale, calling that “specific” personal jurisdiction, and would be contrary to the United States Supreme Court’s recent pronouncements on personal jurisdiction, including in BMS.

Other recent cases have held similarly to the EDMO in Dyson, dismissing non-resident Plaintiffs due to a lack of both general and personal jurisdiction. For example, the Southern District of Illinois has been granting dismissal of non-Illinois Plaintiffs and denying remand in pharmaceutical drug, product liability cases. Specifically, those cases held that misjoined, multi-Plaintiff complaints no longer preclude removal, that there was no general personal jurisdiction pursuant to Daimler AG v. Bauman, 134 S. Ct. 756 (2014) and no specific personal jurisdiction existed pursuant to BMS, and/or found that conducting in-state clinical trials is not sufficient contact to support specific personal jurisdiction in suits by non-residents. SeeBraun v. Janssen Research & Development, LLC, 2017 WL 4224034 (S.D. Ill. Sept. 22, 2017); Bandy v. Janssen Research & Development, LLC, 2017 WL 4224035 (S.D. Ill. Sept. 22, 2017); Pirtle v. Janssen Research & Development, LLC, 2017 WL 4224036 (S.D. Ill. Sept. 22, 2017); Roland v. Janssen Research & Development, LLC, 2017 WL 4224037 (S.D. Ill. Sept. 22, 2017); Woodall v. Janssen Research & Development, LLC, 2017 WL 4237924 (S.D. Ill. Sept. 22, 2017); and Berousee v. Janssen Research & Development, LLC, 2017 WL 4255075 (S.D. Ill. Sept. 26, 2017).

Bringing this back to Dyson, Judge Limbaugh’s decision reaffirms that it really is not that hard to break up Missouri Plaintiffs from non-Missouri Plaintiffs in a product liability lawsuit where the non-Missouri Plaintiffs cannot truthfully allege that their claims arise out of a connection to the state of Missouri (and cannot solely rely on clinical trials occurring in Missouri). This is not to say that non-Missouri Plaintiffs will never find another forum and/or that their claims are foreclosed; rather, those Plaintiffs have a better chance of avoiding a bad break-up by bringing their claims in the forum out of which their claims allegedly arise. 

Missouri Supreme Court May Be Signaling a Change in Analysis of Misjoinder of Claims in Multi-Plaintiff Product Liability Cases

October 19, 2017 | Angela Higgins

On October 13, 2017, the Missouri Supreme Court issued a preliminary writ of prohibition directed to Circuit Judge Rex Burlison of the Circuit Court for the City of St. Louis, temporarily staying the talc case, Valerie Swann, et al. v. Johnson & Johnson, et al.  The Supreme Court case number is SC96704.  The plaintiffs, on behalf of the trial court, are to answer the writ petition by November 13, 2017.

Plaintiff Michael Blaes is one of 47 plaintiffs in the case, who contend that they or their decedents developed ovarian cancer following use of talcum powder.  Johnson & Johnson alleges that Blaes’s decedent did not purchase or use talcum powder in the City of St. Louis.  Blaes’s case was set for separate trial from those of the other plaintiffs, but Judge Burlison declined to formally sever his claim such that it could be reassigned and venue assessed.  That decision is the subject of Johnson & Johnson’s petition for a writ of prohibition.

Missouri has long had a troubled history with venue analysis.  As part of tort reform in 2005, the legislature made significant changes to the venue statute, designed to prevent forum shopping.  The recent explosion in “litigation tourism” focused in the City of St. Louis has not been due to any change in, or deficiency of, the venue statute and the joinder rules, but in changes in the application of long-standing principles of venue and joinder.

Refusal to sever unrelated claims is at the core of the problem.  Litigation tourism in St. Louis depends upon a single, anchor plaintiff who is a Missouri resident with a plausible jurisdictional claim and basis to claim venue in the City of St. Louis, with dozens of unrelated, out-of-state plaintiffs clinging to that anchor plaintiff’s case to justify pursuit of claims in Missouri against non-residents.  The claims are misjoined and should be severed, but to date the Missouri Supreme Court has declined to find that a trial court’s refusal to sever misjoined claims warrants reversal on appeal unless the defendant can establish that the severance decision was prejudicial to the outcome (by establishing that the City of St. Louis is a biased venue).  See Barron v. Abbott Labs., Inc., No. SC96151, 2017 Mo. LEXIS 403, at *6 (Sep. 12, 2017).

Severance has not always been this controversial, but reflects a change in the application of Missouri law and procedure in recent years.  Rule 52.06 of the Missouri Rules of Civil Procedure is titled “Misjoinder and nonjoinder of parties,” and provides that “Any claim against a party may be severed and proceeded with separately.”  Misjoinder of claims or parties requires severance of the claims.  See State ex rel. Gulf Oil Corp. v. Weinstein, 379 S.W.2d 172, 174 (Mo. App. St. L. 1964).

Rule 52.05 identifies the only circumstances under which the claims of multiple plaintiffs may be properly joined in a single action:

All persons may join in one action as plaintiffs if they assert any right to relief jointly, severally, or in the alternative in respect of or arising out of the same transaction, occurrence or series of transactions or occurrences and if any question of law or fact common to all of them will arise in the action.

Mo. R. Civ. P. 52.05(a) (emphasis added).  Both tests must be met for plaintiffs to be joined in a single action.  Id.; State ex rel. Allen v. Barker, 581 S.W.2d 818, 826 (Mo. banc 1979).  If those requirements are not met, the claims are misjoined and severance is required.  Even if joinder is permitted, severance is still permissible in the trial court’s discretion, based upon factors related to fairness, economy, and prejudice.  See Wilson v. Bob Wood & Associates, Inc., 633 S.W.2d 738, 743 (Mo. App. W.D. 1981).

Rule 52.05(a) is analogous to Fed. R. Civ. P. 20(a), which provides that parties may be properly joined only where claims by or against them arise out of the same transaction or occurrence or present common questions of law or fact.  In State ex rel. Allen v. Barker, 581 S.W.2d 818, 826 (Mo.1979) the Missouri Supreme Court discussed the adoption of Rule 52.05(a), recognized that it was patterned after the federal rule, and applied federal cases to interpret it.  Id.  The federal rule has been extensively construed, and overwhelmingly find that the claims of multiple plaintiffs are misjoined when the only commonality amongst plaintiffs is that they allege damages resulting from using the same product.  See, e.g., In re Orthopedic Bone Screw Prods. Liab. Litig., MDL No. 1341, 1995 WL 428683, at *5-6 (E.D. Pa. July 15, 1995).  In the bone screw litigation, the only plaintiffs who were allowed to remain joined in a single action were those who underwent surgery by the same doctor or group of doctors, at the same hospital, and who received the same or a similar device by the same manufacturer.  Id. at *5.  There is no reason in the rule why Missouri should be applying joinder principles in a manner so inconsistent with the federal courts.

Recent jurisprudence in the City of St. Louis and in the Eastern District Court of Appeals, in fact, is inconsistent with those courts’ own past precedent on misjoinder and severance.  In Gulf Oil, plaintiffs had purchased fuel oil in unrelated transactions at different times.  Id. at 174.  These transactions did not constitute the “same transaction nor a series of transactions.”  Id. at 175.  Moreover, even though the plaintiffs all sustained fires, these occurred on different dates.  Id.  Accordingly, the plaintiffs’ losses did not constitute the same “occurrence.”  Id. 

The Gulf Oil court was keenly focused upon what is the “transaction” and what is the “occurrence” that is common to the plaintiffs.  Because the issue is joinder of plaintiffs, it is a plaintiff-focused, not defendant-focused analysis.  Recent jurisprudence on the eastern side of the state has shifted that focus to the notion that plaintiffs’ claims can arise out of the same transaction or occurrence when they derive from common conduct of the defendant, which has been expanded to include the design, marketing, and sale of the product.  In reaching these decisions, the early trial court orders rely upon cases analyzing the proper joinder of defendants, which is, of course, a defendant-behavior-focused analysis.  

Taken to the illogical extreme, the approach of focusing upon the defendants’ business practices and product design to establish joinder would allow any purchaser of a product to join with any single Missouri plaintiff and to pursue their claims in Missouri.  It is simply untenable, and seems inevitable that, if the Missouri Supreme Court does not curtail this problem, the U.S. Supreme Court will.  Allowing non-residents to sue non-residents for extraterritorial conduct and injuries is not constitutionally defensible.  Personal jurisdiction limitations “are a consequence of territorial limitations on the power of the respective States.”  Hanson v. Denckla, 357 U.S. 235, 251 (1958); see also World-Wide Volkswagen Corp v. Woodson, 444 U.S. 286, 292 (1980) (minimum contacts requirement serves the dual functions of protecting defendant against the burden of litigation and ensuring states “do not reach out beyond the limits imposed on them by their status as coequal sovereigns in our federal system”).  

There are hopeful signs – the Eastern District Court of Appeals just overturned the first talcum verdict against Johnson & Johnson for lack of personal jurisdiction.  See Estate of Fox v. Johnson & Johnson, No. ED104580, 2017 Mo. App. LEXIS 1043 (Mo. App. E.D. Oct. 17, 2017).  The dust has not yet settled on these issues, however.

Johnson & Johnson’s writ of prohibition takes a subtly different track from the issue argued in Barron.  In its recent writ, Johnson & Johnson does not argue that Judge Burlison erred in denying the original motion to sever based upon misjoinder of the plaintiffs’ claims, but that, when the court ordered separate trial of each of the claims, that the claims of each plaintiff should have been formally severed such that venue (and presumably jurisdiction) would be independently assessed as to each of the severed claims.

Rule 66.02 provides:

The court, in furtherance of convenience or to avoid prejudice, or when separate trials will be conducive to expedition and economy, may order a separate trial of any claim, cross-claim, counterclaim, or third-party claim, or of any separate issue or of any number of claims, cross-claims, counterclaims, third-party claims, or issues.

Rule 52.06 provides that “Any claim against a party may be severed and proceeded with separately.”  Missouri law has been somewhat ambiguous as to the relationship between these rules, including whether “proceed[ing] separately” with a claim is the same as severing it.

The 3-judge concurring opinion in Barron, upon which Johnson & Johnson relies for its writ petition, suggested that, when the trial court determines that a plaintiff’s claims should be separately tried, it has effectively “severed” that plaintiff’s claims from the remaining plaintiff(s).  Alternatively, where the trial court has determined that the claims should not be tried together, it would ordinarily have no basis to deny a subsequent motion to sever.  Because Mo. Rev. Stat. § 508.012 (part of the 2005 tort reform) requires reassessment of venue when a plaintiff is either added to or removed from the petition, and mandates transfer if venue is improper, the trial court’s failure to formally sever a separately-tried claim deprives defendants of the benefit of the statute.

When there has been severance, the normal administrative process would involve the assignment of a new case number to the severed case and, normally, random judicial reassignment.  Severance of claims permits the court to render separate judgments which will be deemed final for purposes of appeal.  Engel Sheet Metal Equipment, Inc. v. Shewman, 301 S.W.2d 856, 859 (Mo. App. St. L. 1957).  The claims, being independent, would be subject to independent venue and jurisdictional analysis, having been unchained from the Missouri anchor plaintiff.

It is interesting that the Supreme Court has issued a preliminary writ in the Blaes matter.  Although an order for separate trials is not generally deemed to be equivalent to an order for severance, that general principle must be considered in the context of the venue statute, which does contemplate a reassessment of venue.  A court may be required to order severance based upon misjoinder, and the Johnson & Johnson argument seems targeted squarely at overcoming the “lack of prejudice” finding in Barron – the prejudice is in the denial of the rights afforded under Mo. Rev. Stat. § 508.012.  Additionally, where the court has discretion to sever based upon judicial economy, fairness, and prejudice, it still appears to be an abuse of discretion to order 47 separate trials but refuse to sever them into independent actions. 

Johnson & Johnson’s writ petition may be the hook to pry loose severance orders in these multi-plaintiff cases.  Ideally, however, the impropriety of joinder would be assessed at an earlier stage of the litigation, before decisions on trial management have been made.  We are hopeful that recent developments in the talc cases indicates a shift away from recent practices in these multi-plaintiff cases.

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The BSCR Drug / Device Law Blog examines topics and legal developments of interest to the drug and device industry. Learn more about the editor, Angela Higgins, and our Drug and Device practice.


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