Medical Technology and Life Sciences Publications (5)

Risk Management, Products Liability, Series: Risk Management 101, Claims and Litigation

Defending a Products Liability Lawsuit

Medical device and drug manufacturers have no intent or desire to introduce harmful devices or drugs into the marketplace. In addition, FDA’s strict regulation of these companies is...

2 minute read

Risk Management, Series: Risk Management 101, Recalls

Developing a Medical Device Recall Action Plan

Medical device recalls are initiated when a medical device is defective, poses a risk to health, or both. The medical device manufacturer is generally charged with voluntarily initiating...

2 minute read

Risk Management, Products Liability, Series: Products Liability 360, Document Management

Proactive Document Management for Device Manufacturers – Part 2

Part 1 of this article discussed the importance of documents in designing and manufacturing products and how the existence of or lack of drawings, plans, and other records has hurt...

10 minute read

Risk Management, Global Solutions, Series: Risk Management 101, Claims and Litigation

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...

2 minute read

Supply Chains, Outsourcing, Series: Ask an Expert, Claims and Litigation

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...

3 minute read

Risk Management, Supply Chains, Global Solutions, Outsourcing, Series: Ask an Expert

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...

2 minute read

Medical Device Manufacturers, Series: Products Liability 360

Manufacturing and Design Defects

Introduction Manufacturing defects were the original defects envisioned when strict liability was first conceived in the early 1900s. Strict liability was developed in the context of...

13 minute read

Products Liability, Adverse Event Reporting, Series: Products Liability 360, Claims and Litigation

Post-Sale Duties: Common Law and Post-Sale Safety Management

Introduction Merely manufacturing, designing and selling a safe product may not satisfy a product manufacturer’s legal duties. Many years ago, courts held that a manufacturer has a duty...

10 minute read

Risk Management, Products Liability, Adverse Event Reporting, Sales Reps, Warnings and Labels, Series: Risk Management 101, Claims and Litigation

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...

1 minute read

Claims and Litigation, Series: Litigation 360

Crisis Management: Steps You Can Take Now to Be Prepared, Part I

Imagine you learn of a serious adverse event that involves your product. Upon receiving notice of the occurrence, your company is obligated immediately to perform certain activities,...

7 minute read

Filtered on