Publications
Claims and Litigation (3)
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...
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...
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...
Changing Times: What Buyers of Legal Services Need to Know Now
If you think you know how corporate legal services are purchased, you might want to take a second look, because the relationship between companies and their lawyers is rapidly...
The Perfect Storm: Keys to a Successful Products Liability Defense
Snow in Dallas on Thanksgiving day? The last thing anyone expected for the Dolphins - Cowboys game that afternoon. We had been dealing with it the whole game and as it continued to build...
Managing Litigation Expenses: Ebbing the Tide
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...
Battle of the Forms and Contracts
Question:What is the "battle of the forms" and how can life sciences companies benefit from using contracts? Answer: The “battle of the forms” refers to a method of determining...
Preserving Products Involved in Adverse Events
Question:What can a company do to minimize the chance of spoliation of evidence after an adverse event? Answer: Spoliation of evidence is the intentional or negligent...