Publications
Case Resolution Strategies
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....
Spoliation of Evidence
Upon becoming aware of a potential or actual lawsuit, the relevant parties have a responsibility to preserve any evidence potentially related to it. A party who purposely or negligently...
Clinical Trial Insurance: Comparing the Coverage Alternatives
Most buyers of clinical trial insurance look for broad coverage at an affordable, predictable cost. The difference in coverage offered by insurance companies can be confusing and the...
Risk Management 360: Product Classification: Products Liability Implications
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...
Adopting a Safety Policy and Assembling a Safety Team
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...
The Basics of Contractual Risk Transfer
In an age of outsourcing, before a finished medical device or pharmaceutical product reaches its end user, it will be "touched," literally and figuratively, by multiple vendors, such as...
Product Safety Management
Introduction The risk of accidents and products liability can never be completely eliminated. However, potential liability can be minimized by reducing the probability of accidents...
Why Distributors May Be More Vulnerable to Products Liability
Introduction Although most medical device companies today are likely aware of the increasing threat of products liability lawsuits, the risk may not be as obvious to product distributors....
FDA Requirements for Informed Consent Forms
Obtaining informed consent from participants in a clinical trial study is vital. A key document in the informed consent process is the informed consent form. Food and Drug Administration...
Best Practices for Responding to Form-483s and Warning Letters
Perhaps no enforcement actions are dreaded more by life science companies than FDA Form-483s and Warning Letters. This is not only because these actions put the company on the FDA’s radar...