Publications
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...
Crisis Management: Steps You Can Take Now to Be Prepared, Part II
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...
Manufacturer Contact with Patients
Question:What should life sciences manufacturers do if contacted by patients? How much information can the manufacturer pass along, if any? Answer: When responding to a patient...
The Reimbursement Top Ten List
What Investors Will Ask and What Companies Should Know When Developing or Evaluating a New Medical Technology "Build it and they will come" is an anomaly in today's cost-conscious...
Minimizing Risk When Obtaining Informed Consent
Compliance with FDA regulations is only the first step in minimizing the risk associated with the informed consent process. This article provides an overview of requirements and several...
Improving Recall Effectiveness for Medical Devices
As we all know, recalls can be one of the most costly and damaging events in any manufacturer’s corporate experience. Not only do recalls bear tremendous reputation implications, but they...
Risk Shifting Through Contracts
Abstract: In an increasingly global economy, medical device manufacturers are finding that they must rely more and more on supply chains in order to control costs and successfully compete...
Another Step to Claim Resolution With a Medicare Claimant
Introduction On December 29, 2007, former President George W. Bush signed into law the Medicare, Medicaid and SCHIP Extension Act of 2007, or the MMSEA. The MMSEA amends the Medicare...
What Should Life Sciences Companies Do To Best Prepare Themselves In Anticipation Of Litigation?
Question: What Should Life Sciences Companies Do To Best Prepare Themselves In Anticipation Of Litigation? Answer: Litigation is an unwelcome occurrence for life sciences companies...
Risk Management 360: The Relationship Between Complaint Handling and Products Liability
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...