The District of New Jersey has held that Amazon may be sued under New Jersey law for defective products sold by third-party sellers through its online marketplace.
The dispute in New Jersey Manufacturers Insurance Group...more
The District of Delaware is the latest in a series of courts to require disclosure of third-party funding arrangements, a subject we have previously explored. The Chief Judge in the District of Delaware now joins other courts...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
Last year, we explored the Federal Judiciary’s new safeguards and procedures to protect sensitive court records in light of the SolarWinds Orion cybersecurity breach. Now, as a result of increased hostilities between Russia...more
In this sixth alert in our series regarding the European Parliament’s formal endorsement of a new collective actions legislation titled the Directive of the European Parliament and of the Council on Representative Actions for...more
The U.S. District Court for the Eastern District of Virginia analyzed Federal Rule of Civil Procedure 23(b)(3)’s predominance and superiority requirements for class actions in a recent decision denying a motion to certify a...more
The U.S. Food and Drug Administration (FDA) issued its third draft guidance under the Real-World Evidence (RWE) Program on November 29, 2021. In Real-World Data: Assessing Registries to Support Regulatory Decision-Making for...more
12/9/2021
/ Biologics ,
Clinical Trials ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Research ,
Pharmaceutical Industry ,
Prescription Drugs ,
Real World Evidence ,
Regulatory Oversight ,
Regulatory Standards
The global pandemic has accelerated the Food and Drug Administration’s (FDA) encouragement of real-world data (RWD) and real-world evidence (RWE) (the clinical evidence derived from analysis of RWD), particularly as the FDA...more
In this fourth alert in our series regarding the European Parliament’s formal endorsement of a new collective actions legislation titled the Directive of the European Parliament and of the Council on Representative Actions...more
The U.S. Food and Drug Administration (FDA) issued a draft guidance titled Data Standards for Drug and Biological Product Submissions Containing Real-World Data on October 21, 2021. The guidance provides the Agency’s thoughts...more
11/4/2021
/ Biologics ,
Clinical Trials ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Medical Research ,
Pharmaceutical Industry ,
Prescription Drugs ,
Real World Evidence ,
Regulatory Oversight
The U.S. Food and Drug Administration (FDA) has issued a draft guidance for pharmaceutical companies, sponsors, and researchers sourcing Real World Data (RWD) from health records. As the FDA’s first attempt to define...more
In this third alert in our series regarding the European Parliament’s formal endorsement of a new collective actions legislation entitled the Directive of the European Parliament and of the Council on Representative Actions...more
The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule...more
8/10/2021
/ Final Rules ,
Food and Drug Act ,
Food and Drug Administration (FDA) ,
Intended Use ,
Life Sciences ,
Medical Devices ,
Off-Label Use ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Amendments ,
Regulatory Oversight ,
Regulatory Reform
Over the last four months, we have tracked the District of New Jersey’s proposal and adoption of a new Local Civil Rule – L. Civ. R. 7.1.1 – requiring lawyers to disclose details about third-party litigation funding. The...more
Increasingly popular online “lead generation” services offering to connect attorneys with potential mass tort plaintiffs may expose counsel to ethics violations, the New Jersey Advisory Committee on Professional Conduct...more
The U.S. District Court for the District of New Jersey has adopted new Local Civil Rule 7.1.1, requiring lawyers to disclose details about third-party litigation funding. On June 21, 2021, Chief Judge Freda L. Wolfson signed...more
In this second alert in our series regarding the European Parliament’s formal endorsement of a new collective action legislation titled the “Directive (EU) 2020/1828 of the European Parliament and of the Council of 25...more
The Food and Drug Administration Center for Devices and Radiological Health is soliciting feedback on how materials information about medical devices should be communicated to patients and healthcare providers. On May 20,...more
The European Parliament formally endorsed the text of a new collective actions legislation, “Directive (EU) 2020/1828 of the European Parliament and of the Council of 25 November 2020 on Representative Actions for the...more
The United States District Court for the District of New Jersey has announced proposed amendments to its Local Civil Rules, including a new rule – Civ. Rule 7.1.1 – regarding “Disclosure of Third-Party Litigation Funding.” ...more
The United States Supreme Court denied certiorari without comment in two cases seeking to resolve a Circuit split regarding the proof required to establish that a claim for payment was false or fraudulent under the False...more
The U.S. Federal Judiciary announced new safeguards and procedures to protect sensitive court records in light of a recent apparent cybersecurity breach.
Last month, the Department of Homeland Security issued an...more
As the COVID-19 pandemic continues to alter ways of life across the globe, clinical trials must be adapted for participant safety while maintaining accuracy in the midst of the ongoing crisis. In September 2020, the U.S. Food...more
The New Jersey Court Rules were amended in July 2020, effective September 1, 2020. A number of these amendments are important for litigators, and this post provides a summary.
New Jersey Court Rules Governing Motion...more
In a case telling a “sorry story of disloyalty and deception piled upon deception,” the Third Circuit has held that licensees, not only owners, have standing to protect the confidentiality of trade secrets and the right to be...more