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Photo of Eric Hudson

We write a lot about the learned intermediary rule. There are 50 state surveys and  summaries of helpful decisions, as well as numerous posts on state-specific decisions. We tracked the development of the rule in jurisdictions like West Virginia and Arizona, and we’ve generally been pleased to report positive developments. At the end of 2024, though, we flagged the Himes case from California as one of the ten worst decisions of the year based on its novel approach to warnings causation.  Given our criticisms of Himes, we found it both bizarre and troubling to see the case cited recently by an MDL court in Massachusetts applying Pennsylvania law. Our colleagues in the plaintiffs’ bar are clearly advocating to expand Himes into other jurisdictions, and the defense bar should be ready to counter those efforts.Continue Reading Himes Makes a Sneak Appearance on the East Coast

Photo of Lisa Baird

Local counsel in one of our cases made it clear that unless we wanted to broadcast that we were from out of state, we needed to pronounce Oregon as “Or-gun” not “Or-ah-gone”, and we have tried to remember that tip ever since.  But today’s District of Oregon case, Glover v. Avanos Med., Inc., No.

Photo of Steven Boranian

The MDL and state court proceedings involving saxagliptin-based diabetes drugs (such as Onglyza and Kombiglyze) strike us as the mass tort that never should have been.  These proceedings initially followed a familiar model—a publication identified a signal of a risk (albeit an exceptionally weak signal), and plaintiffs’ lawyers took their cue to collect their inventories…

Photo of Rachel B. Weil

We write on the heels of a long weekend layered with dogs and fun.  The National Dog Show, which you may have watched on TV yesterday, is held about ten minutes from our house, and a fabulous corded Standard Poodle named Joel, who just happens to be “family” (he is the sire of our gorgeous puppy, Luca) won Best of Opposite Sex two days running (and stayed overnight with us).  And two out-of-town handlers we know unexpectedly needed a place to exercise their charges, so we twice got to stand in our back yard while no fewer than seven show dogs, from ten pounds to 150 pounds, swirled around us.  We can’t imagine being much happier.

Layers of good mark today’s case, as well.  Arevalo v. Mentor Worldwide LLC, et al., 2022 WL 16753646 (11th Cir. Nov. 8, 2022), is a decision on the appeal of a Northern District of Florida decision we liked very much.  Arevalo is a pelvic mesh case.  The plaintiff alleged that mesh devices implanted to treat her stress urinary incontinence and pelvic organ prolapse caused her to undergo mesh removal surgery and to suffer a familiar litany of injuries.  The plaintiff’s general and specific causation expert was the ubiquitous Dr. Bruce Rosenzweig.  Among numerous other motions, the defendant moved to exclude Dr. Rosenzweig’s specific causation opinion as unreliable because Dr. Rosenzweig did not perform an adequate differential diagnosis.  The court granted the motion and excluded the specific causation opinions, holding that Dr. Rosenzweig “did not explain how he systematically and scientifically ruled out the other potential causes for the plaintiff’s symptoms.  Arevalo, 2022 WL 1673646 at *4.  The court then granted summary judgment for the defendant because the plaintiff could not reach the jury without expert specific causation testimony.  The plaintiff appealed to the Eleventh Circuit, and today’s decision is the result. Continue Reading Eleventh Circuit Affirms Exclusion of Flawed “Differential Diagnosis” in Pelvic Mesh Case

Photo of Rachel B. Weil

For the first time in two years, we write from the confines of our office in downtown Philadelphia.  While we loved the full-time “work from home” regime, we have fondly re-embraced the near-forgotten view from our 30th-floor window, along with our Dancing Barney doll, our RBG action figure, and our solar-powered effigy of…

Photo of Rachel B. Weil

Before we turn to today’s case, a quick update:  when last we spoke, we were about to board a plane for Peoria – our first work trip in sixteen months.  We were excited about it.  We regret to report that we stepped out of the plane into something resembling a weird post-apocalyptic Mad Max movie. …

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.
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