Recent Publications
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.
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
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
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
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
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
Astute life sciences companies purchase products liability insurance to assure the protection of their assets and reputations in the event a claim arises alleging their product caused bodily injury or property damage. In selecting appropriate coverage, these companies, with the sound guidance of their brokers weigh several considerations including the reputations of the various carriers, the size of the appropriate policy (in terms of limit), and the amount of premium owed. Despite the attention devoted to insurance selection, however, several factors seem to go overlooked during this process,
Introduction 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. This article provides an overview of depositions in the context of life sciences products liability cases, including an introduction to the different types of depositions taken in these cases. As we’ll see, although all depositions are ostensibly fact-finding exercises, the true objectives of a deposition vary based on the type of witness being deposed. Understanding the nature and significance of each unique ty
You’re the CEO of a medical device company that manufactures implantable orthopedic devices. Your company has enjoyed years of success with limited FDA involvement. But then the Warning Letter arrived. It was followed by a recall notice. The lawsuits came pouring in soon thereafter. How will your company manage the expenses associated with this flood of litigation? This article will briefly describe different types of litigation expenses and the various strategies used to manage them. Some of these strategies include: Clear expectations for counsel through detailed Litigation Guidelines Stra
Large or small, every life science or medical technology company will eventually have to deal with a products liability claim or event. A lack of adequate planning for such an occurrence can result in damage to the brand, loss of consumer confidence, harm to the business and trigger potential regulatory consequences as well as result in possible business or tort claims. Two ways a company can seek to avoid these issues at the outset and mitigate the disruption such situations can cause is to have a product safety policy and product safety group in place. This article will briefly discuss consi
This second installment of the “Crisis Management” segment of our Litigation 360 series addresses actions that a life sciences company can take immediately following notice of an adverse event to ensure the most positive outcome or least disruptive resolution. Although a company may not be able to undertake these steps until the event has occurred, preparation is no less important as pre-established procedures should be in place to provide a roadmap to follow in the wake of an adverse event. This article explores what those procedures should look like and what companies should devote attention
When products liability claims arise, we often conceive of the options for resolving them as binary—either settle the claim or, should settlement not be reached, litigate it in a trial. The notion of settlement and litigation as the only two options for claim resolution is outmoded, however, and alternative dispute resolution (ADR) techniques are becoming increasingly common as means of effectively resolving claims. These alternatives—principally mediation and arbitration, on which this article will focus—offer the opportunity for a more robust presentation of evidence and structured negotiati
Products liability litigation has several unique facets when life sciences products are involved. Having explored several areas in which this is particularly true—case resolution, crisis management, product preservation, and more—this article compiles the take-aways and best practices from the exploration of each area. Litigation Challenges for Life Sciences Companies Jury Bias There are numerous challenges that crop up for life sciences defendants. First, there is a prevalent anti-corporate sentiment pervading modern jury pools. This sentiment appears to be even stronger with respect to dr
Imagine you learn of a serious adverse event that involves your product. Upon receiving notice of the occurrence, your company is obligated immediately to perform certain activities, which first includes investigating your product’s alleged failure. When the adverse event signals a wider threat and the public’s safety is potentially at risk, you may need to undertake a recall or other post-market corrective action to prevent additional injuries. Who is in charge of coordinating your response to the crisis, and how can you undertake a recall with minimal interruption to your normal operation
Any number and variety of crises can threaten a life sciences company and ultimately interrupt its operations, impact its bottom line, and damage its brand reputation. Perhaps it is the FDA issuing a Warning Letter or demanding the initiation of a product recall. It could be a very observant member of the plaintiffs’ bar watching reports of adverse events and seeking patients injured by the product. All companies hope that they never encounter the worst case scenario in which a product problem gives rise to a rash of serious injuries or deaths, causing―among other serious problems―front page n
The tripartite relationship describes the dynamic between an insurer, an insured, and a defense attorney hired by the insurer to defend the insured. Its scope and defense counsel’s rights and obligations to its clients within this relationship are among the most debated topics in insurance law. This article discusses the various conflicts that may arise and outlines certain insurance policy provisions that may be impacted by this relationship. It is important for life sciences companies to be aware of these dynamics so that a successful resolution–for all parties–can be achieved. But is it rea
Introduction Being the recipient of a lawsuit is unsettling and disruptive to any company. Not only can it be expensive to defend against, but the process itself can be complex, confusing and require much more time and attention than might be fully appreciated. In this article, we will provide a broad overview of products liability litigation in the United States and the various procedural requirements you may encounter. We will walk you through the process by which a typical products liability lawsuit against a life science company unfolds. Our description is general, and the underlying issu
In addition to the challenges that were addressed in the previous installment of Litigation 360—negative jury biases and joint and several liability implications—there are a couple of other elements complicating the products liability litigation landscape for life sciences companies that deserve consideration. These are: (1) transparency as a regulated industry and (2) the sensitivity of life sciences consumers as a plaintiff class. This article will address each in turn. Finally, this two-part look at litigation challenges for life sciences companies will conclude by turning to what companies
Introduction The United States is widely regarded as the most litigious country in the world―and for good reason. The U.S. has the most lawyers per capita, and spends the most money—both in dollars and as a share of gross domestic product—on litigation. Doing business in a litigious society can be difficult for any business, but life sciences companies face some unique challenges related to litigation. The Litigation 360 series will describe these challenges and provide some general guidance to assist life sciences companies minimize the likelihood of litigation, and maximize the chances of su
Introduction Products liability is one of the most important U.S. legal developments in the last 100 years for numerous people and entities: consumers, product-users including hospitals and health care practitioners, manufacturers and others who produce and sell products, government regulators, insurance companies who insure the defendants in these claims and lawsuits, and, of course, lawyers for the plaintiffs and defendants. This liability has bankrupted manufacturers and insurance companies, caused manufacturers to stop making and selling certain products, and created entire industries of
