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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.

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

On its face, Osos v. Nuvasive, Inc., 2024 WL 3585092 (E.D. Mich. July 30, 2024), is a fairly routine medical implant product liability lawsuit, involving allegations of metallosis that have already been around the block quite a few times in hip implant cases.  Osos involves a somewhat different device, but the legal principles are no different.

But Osos involves Michigan law, and Michigan (as we first mentioned at the end of last year, and discussed more thoroughly here) only recently repealed a longstanding conclusive presumption of non-defectiveness based on FDA drug approvals.  That presumption, which “functionally foreclosed” most product liability claims against, such products, White v. SmithKline Beecham Corp., 538 F. Supp.2d 1023, 1029 (W.D. Mich. 2008), undoubtedly reduced litigation by Michigan plaintiffs.  See Our “Michigan Diaspora” post.  The repeal will equally undoubtedly cause Michigan prescription medical product litigation to rebound.Continue Reading Possible Learned Intermediary Showdown in Michigan

The Supreme Court’s recent landmark decision in Loper Bright Enterprises v. Raimondo, 144 S. Ct. 2244 (2024), has generated more commentary than anyone could possibly read.  Reed Smith alone has issued four Loper Bright alerts and established a resource center.  Overall, we think that Loper Bright’s assertion that judges know better than administrative agencies how to interpret and apply those agencies’ organic statutes smacks of judicial triumphalism.  However, it is what it is, and we’ll be living with it for some time.

Loper Bright essentially tells courts to ignore administrative interpretations and to give statutes “the reading the court would have reached if no agency were involved,” 144 S. Ct. at 2266 (citation and quotation marks omitted).  One thing that we (and Mark Herrmann, who first suggested this topic) haven’t seen in any commentary on Loper Bright are the implications of that mandate on the FDA’s questionable basis for its ban on all “off-label promotion” – particularly truthful off-label speech – by the firms it regulates.Continue Reading Could Loper Bright Finally Do in FDA’s Rickety Off-Label Speech Ban?

We’ve reviewed litigation precedent concerning causation-related genetic testing orders on the Blog twice before, in 2020 and in 2015.  We even proposed a rule of federal procedure to govern the conditions under which such testing could occur, which predictably went nowhere, since there is no crisis – yet.  Here’s another update.

As we discussed

As many of you no doubt already know, the federal judiciary’s Committee on Rules of Practice & Procedure gave its final approval to new Fed. R. Civ. P. 16.1, concerning MDL practice, on June 4.  Here’s some commentary.  We’ve also mentioned the proposed rule here on the Blog.  Bexis went so far as to file an extensive comment on the proposed rule, primarily decrying the frequency with which MDL judges simply ignored the existing federal rules – most significantly (although hardly exclusively) those rules that act to weed out meritless claims in non-MDL situations.

Throughout the process that led to new Rule 16.1, the drafters consistently refused to impose any mandatory procedures at all for early vetting of the hordes of meritless to utterly frivolous claims that are routinely filed in mass tort MDLs.  Thus, we bloggers were skeptical that all the effort to create a new, entirely voluntary list of potential MDL management tools was worth the candle.  Indeed, new Rule 16.1 stands out like a sore thumb among the Federal Rules of Civil Procedure, precisely because it lacks any mandatory requirements.  The new rule has lots of “shoulds” but practically no “shalls.”  See Approved Committee Note and Text of Fed. R. Civ. P. 16.1.

Taking a closer look, we now believe that, if used according to its terms, new Rule 16.1 would actually be better than no rule at all, albeit not by a lot.  MDL cases now comprise over 70% of the total federal caseload, so we still believe it is ludicrous that those cases are not subject to a single mandatory MDL-specific rule.  But Rule 16.1 it is what it is.Continue Reading New Rule 16.1 – Better Than Nothing, But Not by a Lot

We could care less about almost everything in Driver v. Naranjo, 2024 WL 2869367 (S.D. Cal. June 6, 2024), which dismissed an overly litigious pro se prisoner’s product liability and other claims involving his purportedly forced use of a prescription drug.

But Driver’s first footnote raises an interesting question of judicial notice – whether notice can extend to the “characteristics” of prescription medical products. Driver held that “[t]he Court may take judicial notice of medical facts regarding prescription drugs, their active ingredients and effects.”  2024 WL 2869367, at *1 n.1.  The opinion cited two cases for that proposition, United States v. Howard, 381 F.3d 873, 880 & n.7 (9th Cir. 2004) (taking judicial notice of certain effects of a drug listed in the product warnings reprinted in the Physician’s Desk Reference (“PDR”)); and Lolli v. County of Orange, 351 F.3d 410, 419 (9th Cir. 2003) (“Well-known medical facts are the types of matters of which judicial notice may be taken.”) (citation omitted).Continue Reading Are Prescription Medical Product Characteristics Subject to Judicial Notice?