Federal Rule of Civil Procedure 26(a)(2) requires retained expert witnesses to provide an expert report which gives “a complete statement of all opinions the witness will express and the basis and reasons for them.” Fed. R. Civ. P. 26(a)(2)(B)(i). If a party fails to disclose information required under Rule 26(a)(2), “the party is not allowed to use that information or witness to supply evidence on a motion, at a hearing, or at a trial, unless the failure was substantially justified or is harmless.” Fed. R. Civ. P. 37(c)(1). As a plaintiff in the Western District of Washington recently learned, failure to adhere to Rule 26 can be fatal to a case.
It is not often that a federal district court limits an expert witness’s proffered testimony on the ground that the expert is not qualified to offer it, and it is also uncommon for a court to exclude expert testimony on the ground that it would not assist the trier of fact. However, the Western District of Louisiana recently limited a proffered engineering expert’s testimony on both of those grounds.
In Terral River Service, Inc. v. SCF Marine, Inc., No. 3:19-CV-00406, Plaintiff purchased a barge from Defendant and later found it partially submerged due to a fracture in the bow. The parties disputed the timing of the fracture, with Plaintiff alleging that it existed prior to delivery of the barge. Plaintiff offered as an expert witness a metallurgical and mechanical engineer with experience in evaluating barge fractures.
On December 8, 2020, the Second Circuit Court of Appeals affirmed the Southern District of New York’s granting of summary judgment in favor of Bayer — and resulting closure of all cases against Bayer — in the Mirena multidistrict litigation (MDL). In re Mirena IUS Levonorgestrel-Related Prod. Liab. Litig. (No. II), No. 19-2155, 2020 WL 7214264 (2d Cir. Dec. 8, 2020).
In the MDL, the plaintiffs alleged that the Mirena Intrauterine System had caused them to develop idiopathic intracranial hypertension (IIH). The District Court elected to focus first on whether the plaintiffs had evidence sufficient to establish general causation. The District Court held a Daubert hearing that lasted three days and featured testimony by 19 general causation witnesses — 7 for the plaintiffs and 12 for Bayer. On October 24, 2018, the District Court entered a detailed 156-page opinion granting Bayer’s Daubert motion as to all of the plaintiffs’ experts and denying as moot plaintiffs’ motion to preclude Bayer’s experts. In re Mirena IUS Levonorgestrel-Related Prods. Liab. Litig., 341 F. Supp. 3d 213 (S.D.N.Y. 2018). Bayer then filed a motion for summary judgment, which the District Court granted for lack of general causation and dismissed all cases in the Mirena MDL.
The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics license applications (BLAs) for biosimilar and interchangeable products, and for other parties interested in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This new guidance aims to further facilitate the development of proposed biosimilar products and proposed interchangeable products.
The BPCI Act created an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product. This newly released draft guidance is the third FDA question-and-answer guidance on the BPCI Act, with the previous two released in December 2018: Questions and Answers on Biosimilar Development and the BPCI Act Guidance for Industry and New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).
The Pennsylvania Superior Court, the state’s mid-level appellate court, recently held in Kornfeind v. New Werner Holding Co., 2020 PA Super 266, that Pennsylvania’s “borrowing statute” applies only to foreign statutes of limitation and therefore does not require application of a statute of repose enacted in the state where the plaintiff used the product and was injured. But the Court also held that statutes of repose are substantive under Pennsylvania law, and therefore the statute of repose from the state of use and injury may bar the claim in a Pennsylvania court if Pennsylvania’s choice of law rules support application of that state’s law.
On June 15, 2020, the U.S. Food & Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) that permitted emergency distribution of chloroquine phosphate (CQ) and hydroxychloroquine sulfate (HCQ) from the Strategic National Stockpile. (https://www.fda.gov/media/138945/download) The FDA concluded, based on clinical trial data and the continuing failure of treatment guidelines to support use of CQ or HCQ to treat patients with COVID-19, that “it is no longer reasonable to believe that oral formulations of HCQ and CQ may be effective in treating COVID-19, nor is it reasonable to believe that the known and potential benefits of these products outweigh their known and potential risks.”