Rule 702

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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

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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…

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This post is from the non-Butler Snow side of the blog.

When you represent medical device manufacturers in product liability litigation, you will deal with allegations that a device broke or failed because of what it was made from, and you will encounter both experts and “experts” (scare quotes intended) in materials science. 

Materials science…

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Lord knows, there are a lot of meritless MDLs.  Bexis’ and Michelle’s Bone Screw litigation, prompted by a televised CYA freak-out by then-FDA Commissioner David Kessler over an off-label use that had become the medical standard of care, was one, and it gave us Buckman.  Several MDLs against modern anticoagulants, such as Xarelto, are another example, since all of those second-generation drugs were safer than the older forms of blood thinners they superseded.  Currently, the Taxotere MDL – based on the dubious proposition that the plaintiffs cared more about hair loss than most effectively treating their breast cancer – and Zostavax – where not a single plaintiff can prove causation – come to mind.  Our colleagues defending other MDLS can also be excused for believing that their own litigation should be added to this list.

But for sheer factual baselessness, it would be hard to top the still-ongoing Avandia MDL, which somehow has managed to persist since 2007.  The Avandia litigation is infamously based on a purported increased risk that, over a decade ago, the FDA scientifically determined did not exist.  Briefly, a study erroneously found an increased risk of cardiovascular events with Avandia that led to both a boxed warning and additional studies.  The additional studies debunked that supposed increased risk and the FDA removed the boxed warning:Continue Reading Avandia Litigation – Is This Finally the End?

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This post is from the non-Reed Smith, non-Dechert, and non-Holland & Knight side of the blog. 

We have covered the ranitidine litigation before. As we explained in prior posts (including here and here), plaintiffs allege that ranitidine, the active ingredient in Zantac, breaks down into N-Nitrosodimethylamine (“NDMA”), particularly at higher temperatures.  NDMA is a known carcinogen and a ubiquitous substance present in the environment and in all manner of foods including bacon, beer, and cheese.  Readers will remember that in a sweeping, 341-page opinion, the MDL court cut the head off the federal Zantac litigation by excluding plaintiffs’ experts.  But other parts of the snake keep slithering. Continue Reading Delaware Zantac Court Fails to Keep the Gate

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We like decisions applying Fed. R. Evid. 702 that recognize the recent amendment’s impact on judicial gatekeeping. A status update on post-amendment decisions is here, and there’s a lot to like.  We don’t like post-amendment decisions that barely recognize the amendments to Rule 702 and instead parrot pre-amendment case law. As key proponents of the recent rule amendments continue to emphasize, “Don’t Say Daubert.”  Hunt v. Covidien, 2024 WL 2724144 (D. Mass. May 28, 2024) says a lot about Daubert and pre-amendment case law, but very little about the recent rule amendments. Nonetheless, the decision excludes entirely the opinions of an expert regularly disclosed by plaintiffs on FDA regulatory issues—Dr. Laura Plunkett. Continue Reading Mixed Bag Rule 702 Ruling from D. Mass.

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Over the last month, Bexis attended both the Hollingsworth Firm’s annual toxic tort litigation defense seminar and the Lawyers for Civil Justice spring meeting.  Both meetings featured discussions on how the new amendments to Fed. R. Evid. 702 were faring in court.  We’ve also written several blogposts (links below) about favorable applications of the new rule, which became effective December 1, 2024.  The amendments having been in effect now for several months, we decided to see whether they were having the Rules Committee’s desired effect of toughening up judicial consideration of expert testimony under Rule 702.  So we’re taking a more systematic look at the judicial response to the 2023 amendments.Continue Reading How Are the Recent Rule 702 Amendments Faring in Court?

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We continue to be cautiously optimistic that the recent amendments to Fed. R. Evid. 702 – enacted because too many courts had been too flaccid for too long in admitting dubious “expert” testimony – will actually improve things in the courtroom.  Our latest data point is In re Paraquat Products Liability Litigation, ___ F. Supp.3d ___, 2024 WL 1659687 (S.D. Ill. April 17, 2024).  While Paraquat is not drug/device litigation (the substance is a widely used herbicide), the Rule 702 analysis has broad applicability – as demonstrated by the decision’s reliance (in part) on the Acetaminophen decision that we discussed here.Continue Reading Amended Rule 702 – Eradicates Invasive Experts on Contact

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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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