Publications
Series: Ask an Expert (2)
Mensing and Its Impact
Question:What is Mensing and what is its impact for generic-drug manufacturers? Answer: In Pliva, Inc. v. Mensing1, the U.S. Supreme Court provided its latest pronouncement on...
Claims Burgeoning in California Courts
Question:Why are we seeing more life sciences cases in California? Answer: One of the biggest obstacles facing defendants in medical device litigation is jurisdiction and forum...
Mitigating the Risks of Foreign Suppliers
Question:How can life sciences companies mitigate the products liability risks associated with using foreign suppliers? Answer:As pricing pressures weigh on medical device and...
Do distributors require professional liability insurance coverage in addition to products liability insurance coverage?
Question:Do distributors require professional liability insurance coverage in addition to products liability insurance coverage? Answer: No, at least not “professional...
The Future of Supply Chain Management
Question:What can the life sciences industry learn from the aerospace industry’s Nadcap program for supply chain management? Answer: Partly as a result of the growing complexity...
Product Labeling Requirements
Question:How do product labeling requirements differ between medical devices and pharmaceuticals? Answer: The FDA has stringent regulations regarding the labeling of medical...
Off-Label Promotion
Question:What risk management precautions should a firm take if significant sales are derived from off-label use of its drug or device? Answer: Promoting medical devices and...
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...
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...