Just a decade ago, it was still an open question whether parties could challenge the admissibility of expert testimony in class certification proceedings. The United States Supreme Court recognized the issue in Wal-Mart...more
It is axiomatic that a plaintiff must offer evidentiary support for each element of her claim in order to survive summary judgment. And a ubiquitous feature of product liability actions is the use of expert witnesses by both...more
It is not uncommon for an opposing expert to opine that the existence of injury alone implies negligence, nor is it unusual to find that such opinions are supported only by general reliance on “literature” with no discernible...more
A plaintiff who alleges that a product is defective usually has to offer expert testimony in support of that allegation. This should come as no surprise for complex products – if it took a team of scientists and engineers to...more
Early last year, the In re: Incretin-Based Therapies MDL court held that the plaintiffs’ warnings claims were preempted, excluded plaintiffs’ general causation experts, and granted summary judgment to all defendants on dual...more
Multidistrict litigation is often criticized for enabling plaintiffs to file meritless cases and then hide in large inventories, hoping to be swept up in a settlement (whether global or otherwise) before the case is...more
ase In the wake of March Madness, it is only appropriate to call attention to an opinion laced with pithy basketball puns. In Nachimovsky v. Nike, Inc. et al., 2022 WL 943421 (E.D.N.Y. Mar. 29, 2022), Plaintiff injured his...more
In the space of a single paragraph, General Electric Co. v. Joiner softened Daubert’s comment that a court’s assessment of expert opinion admissibility should focus “solely on principles and methodology, not on the...more
For over two decades, dating back to Daubert and the ensuing amendments to Rule 702, federal district courts have been charged to act “as gatekeepers to exclude unreliable expert testimony.” Fed. R. Evid. 702 advisory...more
Although product liability actions are governed by state tort law, they frequently find their way into federal court on diversity jurisdiction. In such actions, federal law provides the procedural rules and state law provides...more
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...more
10/22/2021
/ Decision-Making Process ,
Design Defects ,
Discovery ,
Evidence ,
Failure To Warn ,
Federal Rules of Civil Procedure ,
Health Care Providers ,
Informed Consent ,
Manufacturers ,
Medical Devices ,
Physicians ,
Statute of Limitations ,
Summary Judgment
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...more
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....more
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...more
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...more
On December 9, 2020, the Department of Health and Human Services (HHS) Secretary Alex Azar issued a new notice of declaration under the Public Readiness and Emergency Preparedness (PREP) Act (the Declaration) to provide...more
On December 3, 2020, the U.S. Department of Health and Human Services (HHS) amended its Public Readiness and Emergency Preparedness Act (PREP Act) Declaration for Medical Countermeasures Against COVID-19 in order to clarify...more
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...more
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...more
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...more
6/22/2020
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Drug Treatment ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Off-Label Use ,
Pharmaceutical Industry ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Revocation ,
Secretary of HHS
Over the last seven weeks, industry participants contributing to the COVID-19 pandemic response efforts have looked to the Public Readiness and Emergency Preparedness Act (the PREP Act), 42 U.S.C. § 247d-6d, for critical...more
The Food and Drug Administration’s (FDA) recent draft guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products – Questions and Answers,” offers insight and...more