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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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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last mention of it was in 2021, noting that en banc reargument had been granted and the singular panel opinion had been withdrawn.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?

The plaintiff in Kane v. Covidien LP, 2025 U.S. Dist. Lexis 25718 (E.D.N.Y. Feb. 12, 2025), lost the bulk of her case recently, on a motion to dismiss no less.  In this case involving surgical staples, strict liability and negligence claims (which, in New York, are “functionally synonymous,” id. at *18) for design and…

As anyone who has read more than a paragraph of what we’ve written knows, this is a forthrightly pro-defense Blog.  It is not our practice to criticize the strategy or tactics of defendants or their counsel.  It’s not that what defendants do is always right, but to us its almost always understandable.

We were all…

In the last few months, we have discussed two decisions rejecting claims made by plaintiffs in prescription medical product liability litigation that medical device manufacturers somehow had a duty to warn about claimed risks that occurred when their products were used (by physicians, of course) in conjunction with some other product.  In Silverstein v. Coolsculpting…

We were promised “radical transparency” by the incoming Secretary of HHS.  We recently received something that, while meeting the description of “radical,” doesn’t exactly fit the definition of “transparent.”  Since 1971, that is for over 50 years, HHS has had a policy called the “Richardson waiver” (after Elliot Richardson), whereby it expanded the “notice and comment” concept created by the Administrative Procedure Act, beyond the bare minimum required by the APA itself.  For one thing, as we mentioned most recently here, the FDA takes notice and comment on guidance documents, such as those it issues that concern off-label speech.  As we’ve pointed out many times, guidance documents are not regulations with force of law.Continue Reading “Radical” but Not “Transparent”

Rieger v. Medtronic Minimed, Inc., 2025 Cal. Super. Lexis 14 (Cal. Super. L.A. Cnty. Jan. 28, 2025), is an excellent PMA preemption decision from, of all places, Los Angeles County Superior Court, in California – home of the notorious “the Bank” courthouse.  We have no idea whether Rieger was adjudicated in LA’s Central Civil West Courthouse, but that is the first thing we defense hacks think of when we see a “Cal. Super. L.A. Cnty.” citation.

But a few more like Rieger, and maybe we won’t any longer.Continue Reading Taking Preemption to the Bank

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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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