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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

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This post is from the non-Reed Smith side of the blog.

Defendants in Pizzitola v. Ethicon, Inc., filed motions to exclude two of plaintiff’s experts and both decisions (two orders issued) heavily favored the defense, rejecting recurrent design defect arguments by plaintiffs.

The product at issue is synthetic pelvic mesh.  Plaintiff’s first challenged expert was a gynecologic surgeon.  While is area of practice may overlap with issues in the case, his report went well beyond both relevant issues and his area of expertise.  Namely, plaintiff’s expert wanted to opine that lots of things were alternative designs that in fact were not.  Starting with a different medical procedure altogether.  “It is not an alternative design of any product.  In fact, it is not a product at all.”  Pizzitola I, 2022 U.S. Dist. LEXIS 184352, *6 (S.D. Tex. Oct. 7, 2022).  Plaintiff argued the testimony was relevant to a risk/utility analysis but showing that a different medical procedure may be safer, “does not affect whether a product has utility and/or risks.”  Id. at *7.  The decision to perform a different medical procedure lies within the medical judgment of the treating surgeon and has no bearing on the design of the device at issue.  Id. 

Continue Reading Two Strikes Against Plaintiff’s Experts in Texas Pelvic Mesh Case

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The defendants in Mixson v. C.R. Bard, Inc., ___ F. Supp.3d ___, (N.D. Fla. Sept. 16, 2022) (“Mixson I”), and Mixson v. C.R. Bard, Inc., 2022 WL 7581737 (N.D. Fla. Sept. 23, 2022) (“Mixson II”), by no means won everything, but what they won was more important than what they didn’t, so we’re OK with the results.

Continue Reading Mixson Somewhat Mixed, But We’ll Take It

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In today’s case, Chapman v. AstraZeneca, a Delaware state court granted summary judgment to the defendant pharmaceutical manufacturer after excluding the plaintiff’s causation expert under Delaware Rule of Evidence 702 because the expert’s opinion was not “stated in terms of medical probability.”

The plaintiff claimed that the defendant’s proton pump inhibitor, a class of

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We are headed to Guitar Town.  That’s Nashville to you.  Guitars are played and guitars (including the magnificent Gibson ES-335) are made there. We aim to sample plenty of live music and hot chicken. But the reason for our trip is the Defense Research Institute (DRI) Drug and Medical Device Conference.  Tomorrow we will be

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An interesting issue recently arose (but was not resolved) in In re: Proton-Pump Inhibitor Products Liability Litigation, 2022 WL 2188038 (D.N.J. June 17, 2022) (“PPI”).  The ability of an FDA expert witness to testify was challenged under 18 U.S.C. §207, a federal conflict of interest statute.  We have never seen that statute invoked in connection with an ex-FDA witness before, and apparently neither has anyone else, since the opinion observes that “the fact pattern presented here is something of an unprecedented issue.”  Id. at *4 (citation and quotation marks omitted).  So we thought we’d alert our readers.

Continue Reading Regulatory Witnesses – Something Else To Watch

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We are patrolling the advance sheets for Rule 702 decisions as part of our preparation for an upcoming DRI panel.  Not all of the cases are brand-spanking new and not all are wonderful.  Consider Wood v. American Medical Systems Inc., 2021 WL 1178547 (D. Col. March 26, 2021), for example.   It is a vaginal mesh case