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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are another example, since all of those second-generation drugs were safer than the older forms of blood thinners they superseded.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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As we’ve discussed, such as here, Fed. R. Civ. P. 702 was amended in late 2023, because the Civil Rules Advisory Committee concluded that too many courts were erroneously admitting expert testimony that proponents had not established was reliable.  It does appear that at least some courts are cracking down.  Here’s one from an Eighth Circuit court, which is significant since the Eighth Circuit was one of the worst offenders under the prior version of Rule 702.Continue Reading Frequent Flier P-Side Expert Excluded Under Amended Rule 702