Publications
The Foreign Corrupt Practices Act
What is the Foreign Corrupt Practices Act? The Foreign Corrupt Practices Act (FCPA) is a federal law that makes it illegal for companies to make payments to foreign government officials...
The Learned Intermediary Doctrine
The Doctrine The Learned Intermediary Doctrine provides that a drug or medical device manufacturer has no legal duty to warn consumers of a drug or medical device’s harmful side effects...
You’ve Been Sued, Now What?
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,...
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...
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...
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...
When is a Drug or Device Misbranded?
The Federal Food, Drug, and Cosmetic Act ("FDCA") is a federal law that is a primary source for many rules that impact the pharmaceutical and medical device industries. The FDCA's intent...
Vaccine Injury Compensation Program
The early to mid-1980s was an era of considerable vaccine-related litigation. In response to increasing litigation costs and damage awards, many vaccine manufacturers left the market....
Medical Device Reports (MDRs)
The Food and Drug Administration ("FDA") requires medical device companies to report fatal or serious incidents - or potentially fatal or serious incidents - associated with the use of...