Recent Publications
CMO FDA Regulation: Are CMOs Regulated by the FDA? Part two of a three-part series on the Contract Development and Manufacturing industry and potential products liability and manufacturers E&O risks.
The CMO Landscape: Diversifying to Meet an Evolving Industry. Part one of a three-part series on the Contract Development and Manufacturing industry and potential products liability and manufacturers E&O risks.
Created by the medical technology and life sciences industry in 1979, Medmarc has grown from a small insurance program to insuring the life sciences industry.
In their years working with life sciences companies – large and small – Medmarc’s risk managers have evaluated numerous medical devices and pharmaceuticals as well as their manufacturing and distribution operations and FDA compliance histories. From these experiences, our team of risk managers has developed a unique perspective on this innovative and growing industry. Life sciences companies operate in a heavily regulated and litigated environment. Through studying these companies’ successes, and their missteps, the authors of this series have discerned common trends that can influence a compa
An unfavorable or unintended outcome may occur as a result of the use of a drug or medical device. When a manufacturer learns of such an outcome, it may be required by law to report it to FDA, depending on the severity of the circumstances. Likewise, Medmarc policyholders may also be required by the terms of the insurance agreement to report these events to Medmarc. This document is intended to help Medmarc insureds determine whether a particular event must be reported to Medmarc.
This installment of Risk Management 360 details the most important provisions for life sciences companies to include in their contracts and how to handle contract negotiations with limited leverage.
In this installment of Risk Management 360 explains why contracts are so important to life sciences companies and some particular legal doctrines that make the lack of contracts perilous to doing business in this industry.
In this installment of Risk Management 360, we evaluate the role of complaint handling in a robust products liability risk management protocol. This edition of the series takes a close look at how this important function both fulfills the Quality System Regulations (QSR) requirements and helps companies manage potential products liability exposures.
In this installment of Risk Management 360, we look at clinical trials. This article discusses how products liability that arises from a clinical trial can be mitigated with the right practices and when the sponsor and principle investigator are dedicated to the integrity of the trial, the safety of trial subjects, and compliance with the various laws and regulations that govern the conduct of clinical research. We take a systematic look at the parties involved in a clinical trial, where products liability exposure can arise during a trial, what mistakes company-sponsors make to create liabili
In this installment of Risk Management 360, we set the stage for discussions of specific risk mitigation strategies to come. This article explores the relationship between FDA oversight of medical devices and the implications for future products liability litigation and identifies critical risk management philosophies to which device companies should adhere.
Astute life sciences companies purchase liability insurance to assure the protection of their assets and reputations in the event a claim arises.
Modern litigation is composed primarily of the “discovery” process, and the most visible—and arguably most important—component of the discovery process is the deposition.
How will your company manage the expenses associated with this flood of litigation?
Large or small, every life science or medical technology company will eventually have to deal with a products liability claim or event.
This second installment of our Litigation 360 series addresses actions that a life sciences company can take immediately following notice of an adverse event.
When products liability claims arise, we often conceive of the options for resolving them as binary—either settle the claim or litigate it in a trial.
Products liability litigation has several unique facets when life sciences products are involved.
Imagine you learn of a serious adverse event that involves your product.
Any number and variety of crises can threaten a life sciences company and ultimately interrupt its operations, its bottom line, and damage its brand reputation.
The tripartite relationship describes the dynamic between an insurer, an insured, and a defense attorney hired by the insurer to defend the insured.
