Eric M. Friedman
Eric Friedman guides clients through all stages of product liability litigation, particularly working with expert witnesses to present the science behind clients' products. By leaning on his pre-law history as a biochemist, he is able to identify key arguments for and against clients and craft winning strategies for both motion practice and trial.
View the full bio for Eric M. Friedman at the Faegre Drinker website.
Articles by Eric M. Friedman:
A series of recent rulings out of the Southern District of Texas in an inferior vena cava (IVC) filter case reflect how well-planned discovery can lead to a successful multipronged summary judgment motion and can effectively prune a plaintiff’s ambitious product defect claims. Conn v. C.R. Bard, Inc., No. 4:14-CV-298.
In 2006, plaintiff’s physicians discovered a blood clot in his inferior vena cava. An IVC filter was inserted to prevent the blood clot from causing potentially fatal further injury. Because of plaintiff’s young age, the physician chose a removable filter. Plaintiff reported abdominal pain just four days after the IVC filter was placed. The blood clot was found to have moved and extended through and above the recently placed filter, and the physicians initiated anticoagulant therapy.
Continue reading “Treating Physician’s Informed Consent Process and Decision-Making in Device Selection Lead to Partial Summary Judgment for Device Manufacturer”
On July 28, the FDA approved the country’s first interchangeable biosimilar product. Semglee (insulin glargine-yfgn) is both biosimilar to, and interchangeable with, its reference product Lantus (insulin glargine).
Under the Biologics Price Competition and Innovation Act (BPCIA), biological products (e.g., vaccines and therapeutic antibodies) may come to market by showing that they are “biosimilar” to or “interchangeable” with a “reference product,” which is a biological product that has already been approved by the FDA. A biological product is “biosimilar” if it is “highly similar to the reference product notwithstanding minor differences in clinically inactive components” and “there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.” 42 U.S.C. § 262(i)(2). To date, 28 biological products have been approved as biosimilars.
Continue reading “FDA Approves First Interchangeable Biological Product Under BPCIA”
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.
Continue reading “Failure to Fully Disclose Expert Opinions Results in Summary Judgment”
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.
Continue reading “Western District of Louisiana Says Plaintiff’s Marine Engineering Expert’s Opinions Don’t Hold Water”
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.
Continue reading “Second Circuit Affirms Mirena MDL Court’s “Hard Look” at Plaintiffs’ Experts’ Methodology”
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).
Continue reading “FDA Issues Guidance for Applicants Seeking Biosimilar/Interchangeable Approval”
