Last week the Third Circuit made its most recent move in the Oberdorf v. Amazon case: asking the Pennsylvania Supreme Court whether an e-commerce business – such as Amazon – is strictly liable for a defective product that was...more
The attorney-client privilege is one of “the most revered” privileges established to protect certain communications. The Pennsylvania Superior Court recently held that it was improper for a trial court to order the disclosure...more
The U.S. Food & Drug Administration (FDA) has released a Funding Opportunity Announcement (FOA) titled “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials...more
The District of New Jersey confirmed that members of a corporate family all are represented by the same in-house counsel, whether that counsel occupies an office within the parent company or within a subsidiary, because...more
The U.S. Food and Drug Administration (FDA) has issued three letters (one warning letter and two untitled letters) over the last two months of 2019 directed at four different companies focused on the processing, distributing,...more
1/15/2020
/ Biologics ,
Distributors ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturer Liability ,
Marketing ,
Pharmaceutical Industry ,
Public Health Service Act ,
Regenerative Medicine ,
Regulatory Requirements ,
Stem cells
The U.S. Food & Drug Administration (FDA) has released a final guidance document entitled, “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications,...more
9/26/2019
/ Data Collection ,
FDA Approval ,
FDA De Novo Clearance ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
Medical Devices ,
Patient Access ,
Premarket Approval Applications ,
Transparency
Social media is ubiquitous in our cyber-connected world. For many, the first thing a person does when they wake up, and the last thing that person does when they go to bed is read, post, or otherwise interact with platforms...more
8/19/2019
/ Data Collection ,
Discovery ,
Document Productions ,
e-Discovery Professionals ,
Electronically Stored Information ,
Evidence ,
Federal Rules of Evidence ,
Legal Ethics ,
Online Platforms ,
Social Media ,
Spoliation ,
Websites ,
Young Lawyers
On July 9, 2019, the U.S. Food & Drug Administration (FDA) released the final guidance document “Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry,” which provides information...more
The Third Circuit Court of Appeals has held that online retailers such as Amazon could be held liable for allegedly defective third-party products sold through its website.
In a 2-1 panel decision in Oberdorf v. Amazon.com,...more
7/24/2019
/ Amazon ,
Appeals ,
Internet Retailers ,
Product Defects ,
Restatement of Torts ,
Reversal ,
Sellers ,
Strict Liability ,
Summary Judgment ,
Third-Party ,
Vendor Contacts
The U.S. Food & Drug Administration’s (FDA’s) Least Burdensome Provisions: Concept and Principles: Guidance for Industry and Food and Drug Administration Staff, February 5, 2019, states that “medical device regulation should...more