Drug and Device

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The New Jersey Appellate Division recently released a ruling broadly allowing 510(k) evidence in medical device cases.  Elizabeth Hrymoc, et al. v. Ethicon, et al.,  DOCKET NO. A-5151-17,   467 N.J.Super. 42 (Superior Court N.J., Appellate Division)(March 2, 2021).  Shook played a role in the case as the firm filed an amicus brief for AdvaMed, the…

The American Tort Reform Foundation (ATRF) named nine “Judicial Hellholes” in its new annual report intended to shine a light on lawsuit abuse and its effects. See https://www.judicialhellholes.org/reports/2020-2021-executive-summary

ATRF explains that lawsuit abuse harms average, hard-working Americans by clogging our court system with meritless and frivolous cases; dollars spent fighting lawsuits are dollars taken away…

Increasing attention has been given to the failure of MDL courts to apply the FRCP, particularly Rule 12(b)(6), to address meritless and inadequately pleaded claims on federal dockets in MDLs. In non-MDL cases, such claims are routinely disposed of by Rule 12(b)(6), but in an MDL, avoiding the clear impact of the rules is deemed…

“Bellwether” cases are an important case management tool in many MDL proceedings, which typically include numerous individual claims. A bellwether is the sheep that leads the flock, and in an MDL, these lead “test” cases may shed important light on how a jury will react to the parties’ themes, how credible and persuasive their experts are, and how the court views key legal issues.  This information can at times be as, if not more, important as the amount of the actual verdict.  But to shed meaningful light, the bellwether trials must produce a sufficient number of outcomes to provide relevant guidance, given the variety of fact patterns in a typical MDL.  Outcomes in this context might include motions practice, but often does really mean verdicts.

Recently, the judge overseeing the device MDL, In re Cook Filter MDL (amended bellwether), No. 1:14-ml-02570 (MDL S.D. Ind.)(Third Amended CMO #27, 10/26/2020), has had to confront two issues affecting the litigation’s bellwether case management plan.  The first three bellwether cases ended before trial, and now the pandemic is impacting how a new bellwether trial might proceed.  Accordingly, he issued an order amending the bellwether case process, in essence asking the parties to provide additional information for the selection of viable and appropriate bellwethers.…
Continue Reading MDL Revises “Bellwether” Trial Process

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…