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JAMES M. BECK is Reed Smith's only Senior Life Sciences Policy Analyst, resident in the firm's Philadelphia office. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He has been a member of the American Law Institute (ALI) since 2005. He is the long-time editor of the newsletter of the ABA's Mass Torts Committee.  He is vice chair of the Class Actions and Multi-Plaintiff Litigation SLG of DRI's Drug and Device Committee.  He can be reached at jmbeck@reedsmith.com.  His LinkedIn page is here.

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Our prior TwIqbal post concerning learned intermediary causation was well received by our readers, so we’re back with a second, related (and, as it turned out, even longer) discussion of pleading in prescription medical product warning litigation.

In addition to pleading causation, a product liability plaintiff alleging an inadequate warning must plead how the warning was inadequate.  Sounds rather obvious, but never underestimate the capacity of plaintiffs in our sandbox for failing to plead their cases.  The amount of precedent bouncing lazy plaintiffs for not bothering to allege what (they claim) is wrong with prescription medical product  warnings is surprisingly (or maybe not) extensive.Continue Reading Using TwIqbal To Require Plaintiffs To Identify Claimed Warning Inadequacy

It could be a first-year civil procedure question:  The removability of a case to federal court is determined as of the moment of removal – nothing thereafter can defeat removal.  See, e.g., St. Paul Mercury Indemnity. Co. v. Red Cab Co., 303 U.S. 283, 292 (1938) (a plaintiff cannot “deprive the district court of jurisdiction” “after removal” “by amendment of his pleadings”); 14A C. Wright & A. Miller, Federal Practice & Procedure §3721, at 213 (2d ed. 1985) (once “a case has been properly removed . . . plaintiff[s] cannot successfully do anything to defeat federal jurisdiction and force a remand”).

That is precisely what the petitioner in a pending United States Supreme Court matter, Royal Canin U.S.A., Inc. v. Wullschleger, No. 23-677, is asking the Court to hold.  Oral argument in the Royal Canin case is occurring today.  For more details, including copies of all pleadings, see the SCOTUSblog page.Continue Reading Under the Radar SCOTUS Removal Issue

Anybody who has litigated a prescription medical product liability case knows about the learned intermediary rule, which is now followed in all fifty states.  Just as prescription medical product warnings are routed through prescribing physicians, so necessarily is the causation aspect of such warnings.  The details vary from state to state, but in all learned intermediary cases, correcting an allegedly inadequate warning must cause the learned intermediary physician to do something differently, and that “something” must prevent the plaintiff’s claimed injury.

At the same time, the Supreme Court’s TwIqbal decisions require that plaintiffs plead facts to support the elements of their causes of action.  From the defense perspective, that means that complaints against our clients should be required to plead (at minimum): (1) the identity of the relevant prescriber, (2) what that prescriber would have done differently with a “better” warning, and (3) how that difference would have prevented the claimed harm.  We don’t ask for a lot, but at least one fact supporting these essential causal elements should certainly be mandatory.Continue Reading Using TwIqbal To Enforce Warning Causation in Learned Intermediary Cases

In an earlier post, we discussed how the FDA, for over twenty years, from mid-1997 through mid-2019, created and operated an “alternative summary reporting (“ASR”) system for many (but not all) medical device-related adverse events.  In June 2019 the FDA “formally ended” the ASR program, “revoked all . . . exemptions,” and opened “all” ASR reporting data to the public through “legacy files.”

One quirk of ASR reports is that they could not be included on the FDA’s public “MAUDE” (Manufacturer and User Facility Device Experience) database of medical device adverse events, because the FDA required an incompatible format for ASR submissions.  Predictably, plaintiffs in any litigation where the defendant’s participation in the FDA ASR program was relevant started screaming about “coverups” despite the FDA itself receiving all the adverse report data that it wanted, in a form that made it easier for the Agency to use.  Plaintiffs doubled down on already suspect “failure to report” claims.  They’ve been claiming that, under state tort law, device manufacturers had a “duty” not only to comply with FDA reporting requirements, but to do so in the most public manner possible, even when the FDA preferred streamlined ASR reporting.Continue Reading Cutting Through the FDA Alternative Summary Reporting Fog

This guest post is from the colleagues of our Butler Snow bloggers, written by Beth Roper, Megan Donaldson, and Denise Lee.  It first appeared in their firm online publication “Pro Te Solutio.” Bexis read it and thought it would make a worthy addition to the Blog, and they graciously agreed. Our authors collaborated to collect the law from all 50 states on offers of Judgment.  As always, our guest bloggers deserve all the credit (and any blame) for their efforts.

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Most states have an offer of judgment provision, and many of them are patterned after Federal Rule of Civil Procedure 68 (Maryland, Illinois, New Hampshire, Ohio, Pennsylvania, and Virginia are the exceptions without such provisions). Unlike Fed. R. Civ. P. 68, some states allow either party—not just the defendant—to make an offer of judgment. Even more significantly, a few states also allow a rejected offer to serve as an independent basis for an award of attorney’s fees. Federal courts in diversity cases do not always apply state statutes, but in some cases, these statutes have been deemed substantive and have been applied in federal court.  See Spencer v. Ottosen Propellar & Accessories, Inc., 2019 WL 1090776, at *2 (D. Alaska Jan. 15, 2019)) (holding Alaska R. Civ. P. 68 was substantive law and thus to be applied in federal cases based on diversity jurisdictions); Zamani v. Carnes, 2009 WL 2160569, at *3 (N.D. Cal. July 20, 2009) (“Although [Cal. Code. Civ. P. 998] is a state rule, offer of judgment rules appear to be ‘substantive’ for Erie purposes.”); Am. Home Assurance Co. v. Weaver Aggregate Transport, Inc., 89 F. Supp.3d 1294 (M.D. Fla. 2015) (applying the Florida’s offer of judgment statute); Wheatley v. Moe’s Southwest Grill, LLC, 580 F. Supp.2d 1324 (N.D. Ga. 2008) (applying Georgia’s offer of judgment rule).

Recovery of attorney’s fees is one of the most significant factors that increases the value of making an offer of judgment. In this survey, we first address states that allow attorney’s fees after a rejected offer—although some of these statutes only allow for a limited fee collection. We then discuss offers of judgment that are more like Fed. R. Civ. P. 68, permitting awards of costs only.Continue Reading Guest Post − A 50 State Survey of State Law Concerning Offers of Judgment

Today’s guest post is from Reed Smith counsel, and rock music aficionado, Kevin Hara. He describes the twists and turns of pursuing an unreasonable plaintiff and counsel who unwisely turned down a Florida offer of judgment in a sizable damages/lousy liability case. While the victorious defendant didn’t get all the costs and fees it…

In Clemens v. DaimlerChrysler Corp., 534 F.3d 1017 (9th Cir. 2008), the court, applying California law, correctly “decline[d plaintiff’s] invitation to create a new exception” to that state’s privity requirement “that would permit [plaintiff’s] action to proceed.”  Id. at 1023-24.  “[A] federal court sitting in diversity is not free to create new exceptions” to state law limiting liability.  Id. at 1024 (citing Day & Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4 (1975)).  D&Z held, as we’ve discussed many times:

A federal court in a diversity case is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.

423 U.S. at 4.  And the Supreme Court has kept on saying this.  Erie principles prohibit “federal judges” from “displac[ing] the state law that would ordinarily govern with their own rules.”  Boyle v. United Technologies Corp., 487 U.S. 500, 517 (1988).  “[A] federal court is not free to apply a different rule however desirable it may believe it to be, and even though it may think that the state Supreme Court may establish a different rule in some future litigation.”  Hicks v. Feiock, 485 U.S. 624, 630 n.3 (1988).

But when updating the learned intermediary section of his treatise, Bexis came across a peculiar MDL holding, that because a defendant supposedly “cite[d] no cases” for the proposition “that the learned intermediary doctrine should apply to Plaintiffs’ . . . consumer protection claims” under the laws of California, Maryland, Illinois, and Florida, then “the learned intermediary doctrine should not apply” to claims brought by plaintiffs in any of these states.  In re Natera Prenatal Testing Litigation, 664 F. Supp.3d 995, 1007-08 (N.D. Cal. 2023).  The decision did not cite any precedent from any of these states (not even a trial court decision) affirmatively creating any exception to the learned intermediary rule for consumer fraud claims.  Id.Continue Reading Debunking Another Stunningly Wrong MDL Expansion of Liability

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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