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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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A little while ago, Bexis attended a Lawyers for Civil Justice semi-annual meeting, at which he received that organization’s “Outstanding Contributor Award” (in full disclosure, so did a half dozen other members).  With the soon-to-be-adopted amendments to Fed. R. Evid. 702 having now been approved by the Supreme Court (with only the unlikely step of a congressional veto remaining), the question was what happens next.

These amendments expressly enshrine the expert “gatekeeper” function in the text of Rule 702.  The next step is whether they can be duplicated – or paralleled − in state rules of evidence.  We think that they can, and for a state (like Pennsylvania and a number of others) that still follows the “Frye” standard looking to the “general acceptance” of expert testimony as the touchstone to admissibility, a Rule 702 state-law equivalent might look something like this:…

Continue Reading 50-State Survey of State Court Decisions Supporting Expert-Related Judicial Gatekeeping

For several years, we have blogged about the controversy over whether the American Law Institute (“ALI”) should put its Restatement Third of Torts imprimatur on no-injury medical monitoring.  Here’s the latest update, as that effort nears culmination.  As reported by the ALI, on Monday May 22, at the Institute’s 100th Anniversary annual meeting:…

Continue Reading Always Liability Increases (ALI)?  Not Yet with Medical Monitoring.

The Eleventh Circuit’s recent decision in Rosell v. VMSB, LLC, ___ F.4th ___, 2023 WL 3398509 (11th Cir. May 12, 2023), has nothing whatever to do with prescription medical product liability litigation, but defense counsel should know about it because is rejects one trick that plaintiffs in complex litigation use to claim appellate jurisdiction.  Specifically, it rejects the concept of “partial dismissal” under Fed. R. Civ. P. 41(a), as a tool to create a final appealable order following partial dismissal of an action.…

Continue Reading Plaintiff Cannot Create Appellate Jurisdiction Through Partial Dismissal

Over the past few months, Bexis, with the substantial help of several Reed Smith associates, has prepared a law review article – “Federal Preemption and the Post- Dobbs Reproductive Freedom Frontier” – which will soon be published in the Food & Drug Law Journal.  A draft of this article is now available on SSRN.

The core premise of Bexis’ article is very simple:  Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying “no” and trying to ban that same FDA-approved drug.  It doesn’t matter whether that drug is morphine, methadone, minoxidil – or mifepristone.…

Continue Reading Mifepristone Manufacturer Wins First Round in West Virginia

Each of these cases is significant enough to merit its own post, but since they came down within a week of each other, we’re discussing both of them here.  They are:  Gahl v. Aurora Health Care, Inc. ___ N.W.2d ___, 2023 Wisc. LEXIS 137 (Wis. May 2, 2023), and M.T. v. Walmart Stores, Inc., ___ P.3d ___, 2023 WL 3135662 (Kan. App. April 28, 2023).…

Continue Reading Two New Appellate COVID-Related Developments

Some things make sense only in the topsy-turvy, litigate-everything-to-death world of multidistrict litigation.  One recent example is In re Taxotere (Docetaxel) Products Liability Litigation, 2023 WL 2982464 (E.D. La. March 8, 2023), where MDL-related considerations led a defendant to oppose a plaintiff’s motion for voluntary dismissal with prejudice.

Why?  Think chess.  In MDLs the other side treats plaintiffs like pawns, regularly sacrificing them in the hope of putting one or more defendants in zugzwang (a chess term for forcing an adverse move).  That’s what happened in Taxotere. …

Continue Reading Only in an MDL….

One key point where implied preemption differs from express preemption is that express preemption is inherently limited by the language of the particular statute that contains the pertinent preemption clause, whereas general principles of implied preemption have broad application to all similar cases.  Since the preemption of agency fraud claims recognized in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), was based entirely on implied preemption, Bexis has kept track of non-FDCA applications of Buckman implied preemption in his book.  See § 5.02[4][c] n.294.  Non-FDA-related findings that federal agency fraud claims are preempted include:

Farina v. Nokia, Inc., 625 F.3d 97, 104 (3d Cir. 2010) (FCC); Transmission Agency of Northern California v. Sierra Pacific Power Co., 295 F.3d 918, 932 n.10 (9th Cir. 2002) (FERC); Nathan Kimmel, Inc. v. DowElanco, 275 F.3d 1199, 1204-06 (9th Cir. 2002) (EPA); Murray v. Motorola, Inc., 982 A.2d 764, 770 n.6 (D.C. 2009) (FCC); McCall v. Pacificare, Inc., 21 P.3d 1189, 1199 n.9 (Cal. 2001) (Health Care Financing Administration); Timaero Ireland Ltd. v. Boeing Co., 2021 WL 963815 at *6-7 (N.D. Ill. March 15, 2021) (FAA); LCS Group v. Shire LLC, 2019 WL 1234848 at *6 (S.D.N.Y. March 8, 2019) (patent office); In re Volkswagen “Clean Diesel” Marketing, Sales Practices, & Products Liability Litigation, 264 F. Supp.3d 1040, 1054-55 (N.D. Cal. 2017) (EPA); Syngenta Crop Protectin v. Willowood, 2016 WL 6783628 at *1 (M.D.N.C. Aug. 12, 2016) (EPA); Giglio v. Monsanto Co., 2016 WL 1722859 at *3 (S.D. Cal. April 29, 2016) (EPA); Offshore Service Vessels, LLC v. Surf Subsea, Inc., 2012 WL 5183557 at *11-12 (E.D. La. Oct. 17, 2012) (Coast Guard); Ramirez v. E.I. Dupont De Nemours & Co., 2010 WL 3529509 at *2 (M.D. Fla. Sept. 3, 2010) (EPA); Lockwood v. Sheppard, Mullin, Richter & Hampton, LLP, 2009 WL 9419499 at *7 (C.D. Cal. Nov. 24, 2009) (patent office); Beck v. Koppers, Inc., 2006 WL 2228910 at *1 (N.D. Miss. April 7, 2006) (EPA); Hill v. Brush Engineered Materials, Inc., 383 F. Supp.2d 814, 822 (D. Md. 2005) (EPA, OSHA); Williams v. Dow Chemical Co., 255 F. Supp.2d 219, 232 (S.D.N.Y. 2003) (EPA); Morgan v. Brush Wellman, Inc., 165 F. Supp.2d 704, 722 (E.D. Tenn. 2001) (Dept. of Energy); Zwiercan v. General Motors Corp., 2002 WL 31053838, 58 Pa. D. & C.4th 251, 266 (Pa. Com. Pl. 2002) (NHTSA); Redelmann v. Alexander Chemical Corp., 2002 WL 34423377 (Ill. Cir. July 26, 2002) (EPA).

Now Buckman preemption is the centerpiece of In re Ford Motor Co. F-150 & Ranger Truck Fuel Economy Marketing & Sales Practices Litigation, ___ F.4th ___, 2023 WL 3029837 (6th Cir. April 21, 2023).  Indeed, at least one aspect of Ford F-150 is favorable to Buckman preemption in a way that should be useful in the drug/device field.…

Continue Reading Automotive Preemption Case Has Buckman Front and Center

Arbitration, if done right, is an effective, speedy, and low-cost alternative to civil litigation of all kinds, which is why the other side (or at least the lawyers representing them) hates it.  Unfortunately, with prescription medical products − and their necessary learned intermediary physicians – arbitration doesn’t come up very often in our line of work, although nothing inherent in personal injury litigation precludes mandatory arbitration.

But it might happen more, in the future.  In a think piece we published a couple of years ago, on software liability, we identified arbitration as one of the consequences in litigation where intermediaries (“learned” or otherwise) were out of the picture.  “In direct-to-consumer contexts, providers routinely seek to use contracts such as click-wrap licenses to allocate software-related liability including limitations on liability, forum selection clauses, compulsory arbitration and similar protective measures.”

But our clients might, at least in certain situations, be able to enjoy both the learned intermediary rule as well as mandatory arbitration.…

Continue Reading Oye Cómo Va?  To Arbitration.

At least try to do something different.

As we discussed before, because his prescription drug warning claims collided with federal preemption, the plaintiff in Roshkovan v. Bristol-Myers Squibb Co., 2022 WL 3012519 (C.D. Cal. Jun. 22, 2022), needed to plead what the FDA didn’t know, not what it did, to avoid dismissal.  His second try wasn’t any better than the first.…

Continue Reading When at First You Don’t Succeed…

This is a guest post by Kelly Jones Howell, of Harris Beach and it’s for a good cause.

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DRI’s Drug and Medical Device Committee will hold its annual Seminar on May 3-5, 2023, at the Hilton New Orleans Riverside, in New Orleans, Louisiana.  The Seminar is a preeminent program for practitioners who represent…

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.
Learn More About This Book