Drug and Device

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It is a little surprising, but there continue to be cases in which plaintiffs allege a product was defective, litigate for a long time, but do not produce an expert opinion to that effect.  If the product is at all complex, a jury should not be permitted to guess that the product was defective just

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In Rochkind v. Stevenson, 2020 WL 5085877 (Md. Aug. 28, 2020), the Maryland Court of Appeals (that is the state’s highest court), recently adopted the Daubert standard for assessing the reliability of proffered expert opinion evidence.  This is the test used in federal courts and most other states, but not all.  The court’s move away from the Frye test reflected a “jurisprudential drift” over the past 40 or so years towards more careful scrutiny of expert evidence in an effort to prevent unreliable science from entering into a trial. 471 Md. 1, 5, 236 A.3d 630, 633..

The case involved the claim that plaintiff’s Attention Deficit Hyperactivity Disorder (ADHD) had been caused by her childhood exposure to lead. She sued the landlord of the apartment where she had lived, and sought to rule out other risk factors, such as a family history of learning disabilities, through expert testimony. The landlord challenged the reliability of the proposed expert’s causation methodology and conclusions.
Continue Reading Maryland Adopts Daubert Test

The short opinion in Stirling v. Novartis Pharm. Corp., 2020 WL 4259035 (Idaho Dist. Ct., July 13, 2020), comes at the intersection of personal jurisdiction rules and innovator liability claims.  As readers will recall, plaintiffs who allege injury from ingestion of a generic version of a prescription drug cannot prevail on a failure to…

Amarin Pharma and the FDA recently announced a widely expected settlement of First Amendment litigation over restrictions on the company’s promotion of its Vascepa product.

Readers may recall that this was one of several recent challenges to the FDA’s attempt to restrict off-label promotion of prescription products, even if that speech is truthful and not…