What is the "battle of the forms" and why is it important for
life-sciences companies to avoid?
“Design controls” is a broad term that describes several procedures and processes used throughout the design and manufacture of a product...
When would a medical-device sales representative present in a clinical setting be considered engaging in the practice of medicine?
Following heavy-handed rhetoric by agency chiefs, the FDA recently has increased the number of enforcement actions it has pursued against both entities and individuals.
In Pliva, Inc. v. Mensing, the U.S. Supreme Court provided its latest pronouncement on federal preemption in the context of product liability.
What is the "Learned Intermediary Doctrine" and to what extent does it Protect Prescription Drug and Medical Device Manufacturers from Liability?
If my company receives an FDA-483 or a Warning Letter, how can I respond most effectively?
Do distributors require Professional Liability insurance coverage in addition to Products Liability insurance coverage?
We have been asked by appointed counsel to select someone within our company to respond to and provide evidence for the case. What should we consider when making the selection?
Why is the discovery process so expensive?
What can a company do to minimize the chance of spoliation of evidence after an adverse event?
Which Members of Congress might be expected to lead the health policy agenda for the life sciences industry for 2011?
What should a medical device sales representative do if she observes a surgeon using a medical device incorrectly during a procedure?
What should a medical device sales representative do if an adverse event occurs during a procedure?
If a lawsuit is filed against my company, what can I expect and what can I do to assist defense counsel?
If my company gets a Warning Letter from the FDA, how will it affect our products liability litigation?