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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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MDLs are supposed to follow the Federal Rules of Civil Procedure.  That’s the reminder the Sixth Circuit gave in In re National Prescription Opiate Litigation, 956 F.3d 838, 844 (6th Cir. 2020):

[T]he law governs an MDL court’s decisions just as it does a court’s decisions in any other case. . . .  Here, the relevant law takes the form of the Federal Rules of Civil Procedure.  Promulgated pursuant to the Rules Enabling Act, those Rules are binding upon court and parties alike, with fully the force of law. . . .  Respectfully, the district court’s mistake was to think it had authority to disregard the Rules’ requirements . . . in favor of enhancing the efficiency of the MDL as a whole. . . .  But MDLs are not some kind of judicial border country, where the rules are few and the law rarely makes an appearance.  For neither §1407 nor Rule 1 remotely suggests that, whereas the Rules are law in individual cases, they are merely hortatory in MDL ones.

Id. at  844 (citations omitted).  More recently the Civil Rules Committee made the same point in approving new Fed. R. Civ. P. 16.1:  “The Rules of Civil Procedure, including the pleading rules, continue to apply in all MDL proceedings.”  Comment to Rule 16.1(b)(3)(A).

Bad things happen – usually to defendants – when an MDL adopts practices designed to cut procedural corners that the drafters of the rules put there for a reason.Continue Reading MDL Procedural Shortcuts Once Again Disadvantage Defendants

In a series of what we entitled “reports from the front,” we discussed how the federal government asserted, and eventually won, the right to intervene in ongoing False Claims Act suits to seek their dismissal notwithstanding the objections of the “relators” who were ostensibly pursuing these actions in the government’s name.  Basically, the relators claimed that, unless the government exercised its initial right to take over an FCA suit early on, the government lost all control over the relators, and they could essentially run wild using the government’s name.  The Supreme Court rightfully rejected that view.  United States ex rel. Polansky v. Executive Health Resources, Inc., 599 U.S. 419, 437-38 (2023) (government entitled to intervene and obtain dismissal of FCA action at any time on the basis of any “reasonable argument” regardless of the relator’s position).

However, three justices had more to add – they challenged that entire FCA private-attorney-general system as unconstitutional.  Justice Thomas stated in dissent:

The FCA’s qui tam provisions have long inhabited something of a constitutional twilight zone.  There are substantial arguments that the qui tam device is inconsistent with Article II and that private relators may not represent the interests of the United States in litigation. . . .  [T]he Court has held that conducting civil litigation for vindicating public rights of the United States is an executive function that may be discharged only by persons who are Officers of the United States under the Appointments Clause.  A private relator under the FCA, however, is not appointed as an officer of the United States under Article II.  It thus appears to follow that Congress cannot authorize a private relator to wield executive authority to represent the United States’ interests in civil litigation.  The potential inconsistency of qui tam suits with Article II has been noticed for decades.

Polansky, 599 U.S. at 449-50 (Thomas, J., dissenting) (citations and quotation marks omitted).  Concurring Justices Kavanaugh and Barrett agreed.  “I add only that I agree with Justice Thomas that “[t]here are substantial arguments that the qui tam device is inconsistent with Article II and that private relators may not represent the interests of the United States in litigation.”  Id. at 442 (concurring opinion).

Thus, we commented that “another front opens.”Continue Reading FCA Frontal Assault in Eleventh Circuit

Recently, when putting together our “Staple Suit Cropped” blogpost about Kane v. Covidien LP, 2025 U.S. Dist. Lexis 25718 (E.D.N.Y. Feb. 12, 2025), we realized that, while we had a comprehensive 50-state survey on the questionable status of failure-to-report claims under state law, we did not have a similarly complete reference for preemption of the same reporting-based claims.

We’re rectifying that here.

Failure-to-report claims have been asserted against every product that has a preemption defense – branded drugs, generic drugs, and PMA medical devices.  Thus, there are different ways that failure-to-report claims end up preempted.

  • First, reporting-based claims against drugs or medical devices are impliedly preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), and 21 U.S.C. §337(a), because they would not exist without the FDA reporting obligations that they claim were violated.  Therefore, “the existence of these federal enactments is a critical element” of the cause of action, and implied preemption applies.  531 U.S. at 353.
  • Second, and relatedly, in the majority of states where no state-law claim exists for failure to make mandatory reports to a governmental agency (see the 50-state survey), Buckman further precludes such claims as purely private attempts to enforce the FDCA/FDA regulations concerning adverse event reporting.
  • Third, in cases involving pre-market approved medical devices, the same absence of any state-law reporting-based claims leads to express, as well as implied, preemption because there is no recognized “parallel” state-law theory of liability that could support a “parallel claim” exception to express preemption under 21 U.S.C. §360k(a).
  • Fourth, generic drugs enjoy their own implied preemption defenses under PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and can take similar advantage of Buckman-based preemption precedent.

Obviously, there can be overlap between these three categories, and not all courts keep them separate.

Since the issue is preemption, a federal issue, our primary division of cases is by federal circuit rather than by state.  Of the circuits, the Second, Third, Sixth, Eighth, Tenth, and Eleventh all have precedential decisions holding failure-to-report claims preempted, although the Second has only dealt with express preemption.  The Second, Fifth and Ninth allow “parallel” failure to warn claims to escape preemption if state common law allows them, with the Second being stricter than the others.  The Seventh Circuit has been hostile generally to FDCA-based preemption, but hasn’t decided a reporting-based case.  The First, Fourth, and District of Columbia circuits have yet to decide the question.  We note that no precedential decision from any federal court of appeals has flatly denied preemption in a failure-to-report case since 2013, the 2013 decision was repudiated by the highest court of the state in question (see Ninth Circuit, below), and the United States Supreme Court abolished any “presumption against preemption” in express preemption cases in 2016.  See Commonwealth of Puerto Rico v. Franklin California Tax-free Trust, 579 U.S. 115, 125 (2016).  Thus, defendants have good grounds to seek reconsideration of what adverse appellate authority exists.

Finally, we don’t do the other side’s research for them, so be advised, that while we try to be comprehensive in collecting favorable cases, we aren’t including all adverse decisions. Continue Reading Preemption Round Up – Failure to Report

Not too long ago we saw a story in the legal press about a newly filed case in Minnesota where the plaintiff claimed that the FDA was going easy on the defendant because it approved “hundreds of premarket supplements” rather than requiring “a new PMA application.”  Supposedly “[b]y utilizing the [premarket approval] supplement process instead of filing a new PMA application, [the defendant] avoided the rigorous scientific review, public comment and clinical trial requirements.”

That’s barnyard excrement.  This plaintiff isn’t just wrong s/he is loud wrong – which, for plaintiffs, is unfortunately rather common.Continue Reading Supplemental Authority

A month or so ago, we castigated some extremely poorly reasoned expert exclusion decisions in the Bulox v. Coopersurgical litigation.  The end results weren’t horrible (p-side motions were denied), but th0se Rule 702 opinions completely ignored the changes wrought by the 2023 amendments to that Rule.  It was so striking that we went on PACER to see whether defense counsel was to blame for any of that – they weren’t.

Well, today we’re cheering the latest decision(s) in the same litigation.  Bulox v. Coopersurgical, Inc., 2025 U.S. Dist. Lexis 56370 (Mag. S.D. Tex. March 6, 2005) (“Bulox I”), adopted, 2025 U.S. Dist. Lexis 54755 (S.D. Tex. March 25, 2025) (“Bulox II”), is as good a PMA medical device preemption decision as a defendant has a right to expect.  This Bulox decision should go a long way towards defeating the other side’s latest campaign to deprive women of contraceptive choice.Continue Reading Clip, Clip Hooray

At a recent seminar, one of the sessions was a nuts-and-bolts discussion of conducting Internet, mostly social media, research into prospective jurors for voir dire purposes.  It was quite interesting from a practical standpoint, but no law was cited that such research was even allowable (assuming courts could detect non-courtroom activities), and if so, what restrictions apply.

So we thought we’d take a look.Continue Reading Avoid Getting Into Trouble over Internet Research about Prospective Jurors

Back in 2020, we encountered Gustafson v. Springfield, Inc., 2020 Pa. Super. Lexis  843 (Pa. Super. Sept. 20, 2020), a decision so bizarre that it reminded us of a Monty Python movie.  That decision “employ[ed] a rationale, at once both paleolithically conservative and pro-plaintiffly radical, that would render any federal “tort reform” statute unconstitutional.”  Gustafson involved a federal statute that preempted most tort litigation involving firearms, the Protection of Lawful Commerce in Arms Act of 2005, 15 U.S.C. §§7901, et seq., (“PLCAA”), and declared that the PLCAA violated the Tenth Amendment.

Since it did not involve prescription medical product liability litigation, the Blog did not follow Gustafson all that closely – our last mention of it was in 2021, noting that en banc reargument had been granted and the singular panel opinion had been withdrawn.  However, the decision that resulted from the reargument was a mess.  Gustafson v. Springfield, Inc., 282 A.3d 739 (Pa. Super. 2022) (en banc), produced no majority and five different opinions from the nine judges.  Moreover, the overall result, which was to reverse the trial court’s dismissal of the suit, was contrary to the majority votes of the individual judges.  How could that be?  Here’s a brief description from a Pennsylvania appellate procedure article Bexis wrote about Gustafson:

The outcome in Gustafson thus differed dramatically from the votes of the nine en banc judges on the merits of the two issues.  The outcome was 5-4 in favor of reversal, as four judges would reverse on constitutional grounds, and one judge would reverse solely on statutory grounds.  On both of the two issues, however, the position advocated by the defendants was in the majority.  Seven justices agreed that, factually, the Arms Act was applicable to the Gustafson plaintiffs’ claims.  By a slimmer margin of 5-4, a majority of the Gustafson judges agreed that the Arms Act was constitutional.

J. Beck, “What Happens When Precedent Splinters? A Look at Gustafson,” Law.com (Nov. 17, 2022).

This bizarre result had one beneficial effect, it virtually forced the Pennsylvania Supreme Court to take the inevitable appeal in order to clean up the mess.  Which it did.  See Gustafson v. Springfield, Inc., 296 A.3d 560 (Pa. 2023) (granting review).

And last month, the Pennsylvania Supreme Court did indeed clean up the mess.  See Gustafson v. Springfield, Inc., 2025 Pa. Lexis 442 (Pa. March 31, 2025).Continue Reading At Least Pennsylvania Is Not That Completely Different

Late last year, we discussed the dismissal of three purported California no-injury class actions alleging that certain over the counter (“OTC”) acne medicines were contaminated with carcinogenic benzene.  That post also commented:

By the way, guess who says they found the benzene in the products?  It was that good, old “independent” lab, Valisure −  which proceeded to file a citizen’s petition with the FDA seeking action against [these] products.  Sound familiar?

Last month, the FDA responded to the petition.  The agency was not impressed.  Its own testing – contrary to Valisure’s overblown claims in its petition (“detected high levels of benzene . . . in many specific batches”) found practically nothing to be concerned about.  It tested “95 acne products containing benzoyl peroxide for possible benzene contamination,” and “more than 90% of tested products had undetectable or extremely low levels of benzene.”  FDA, Statement ¶1 (March 11, 2025). THe FDA initiated a “limited number of voluntary recalls” due to “findings show[ing] a small number of products with elevated levels of benzene contamination.” Id.  Only six of 95 products were recalled, and even then, only specified lot numbers.  FDA Statement ¶7.Continue Reading It’s About Time – FDA Calls Foul on Valisure

Today’s guest post is from Reed Smith’s Matt Jacobson. He addresses the latest and greatest result from litigation that has been generating favorable decisions nationwide applying various states’ so-called “blood shield” statutes (practically every state has one) that declare the use of human cells or tissue in medical treatment to be services rather than products, which has the effect of limiting liability to negligence. As always our guest posters deserve 100% of the credit (and any blame) for their work.

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Milovich v. Aziyo Biologics, Inc., No. 1:24-cv-01208-CL, 2025 U.S. Dist. LEXIS 50935 (D. Or. Feb. 24, 2025), involves Oregon’s human blood and tissue shield statute.  The Drug & Device Law Blog has written about similar cases before, but this one might be the best.  Blood shield laws have been around for over 60 years.  They sound like something that Dracula should fear, along with a knife through the heart, the sun, holy objects, and garlic.  But they are not something that should scare anyone who manufactures blood or tissue based products.  While states have different statutory language, the gist of blood shield laws is that blood transfusions and transplants are a service and not a sale (Dracula would agree he is performing a service), thus barring claims for breach of warranty and strict liability.Continue Reading Guest Post – The Sun Is Not Setting on Oregon’s Blood Shield Statute

We’ve written before about the long-running Muldoon v. DePuy Orthopedics lawsuit.  For one thing, it’s been around forever – its facts are almost as old as the Blog.  As we stated here:

Muldoon . . . is a suit over hip-replacement surgery conducted in 2007.  Suit was not filed, however, until 2015 – undoubtedly Muldoon is another example of the flotsam and jetsam dredged up by MDL lawyer solicitation.  So Muldoon was stale from the beginning.  But it got worse. For some eight years, Muldoon sat in the horribly mismanaged Pinnacle Hip MDL in Texas.  It appears that nothing at all happened during those years . . . [until] 2023, when the case was ultimately remanded, without comment.  So, due to the combined lassitude of the plaintiffs and MDL management, the suit is nearly 14½ years post-surgery, and only now being addressed on the pleadings.

(citations and quotation marks omitted).

Finally, in Muldoon v. DePuy Orthopaedics, Inc., 2025 U.S. Dist. Lexis 34013 (N.D. Cal. Feb. 25, 2025), it was dismissed with prejudice.  And in the end, the plaintiff didn’t even put up a fight.  Faced with the defendant’s latest dismissal motion, “[p]laintiff has declined to file any opposition.”  Id. at *2.  What was at stake this time were the claims that had survived the defendant’s first dismissal motion against the plaintiff’s absurdly excessive 18-count post-MDL amended complaint.  We had some words to say about that complaint as well:  “It is a dog’s breakfast.  Or it is what our dogs deliver to our yard right after consuming their breakfast.”Continue Reading Muldoon Dismissed – The End of an Error?

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