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FDA Approves Second Biosimilar – Inflectra™ – The First Monoclonal Antibody Biosimilar

The U.S. Food and Drug Administration announced on April 5 its second ever approval of a biosimilar  –  Inflectra (infliximab-dyyb) – for multiple indications. Inflectra was developed by Celltrion Inc. and licensed to Pfizer Inc., for treatment of rheumatoid arthritis, inflammatory bowel diseases and other conditions.  Inflectra is a biosimilar to Remicade which has been […]

| 3 min read

Arizona Supreme Court Adopts Learned Intermediary Doctrine

The Arizona Supreme Court has issued an opinion adopting the learned intermediary doctrine in Arizona. The Supreme Court rejected the Arizona Court of Appeals’ earlier decision holding that the learned intermediary doctrine was incompatible with the Uniform Contribution Among Tortfeasors Act (“UCATA”). Although the Arizona Supreme Court specifically held that the doctrine applies to pharmaceutical […]

| 3 min read
KW
Former Partner

Arizona Supreme Court Poised to Consider “Learned Intermediary” Doctrine

The Arizona Supreme Court has agreed to hear an appeal of the Court of Appeals’ January 2015 decision regarding the longstanding “learned intermediary” doctrine. In January, the lower court held that the doctrine was inconsistent with Arizona’s system of pure comparative fault. Under the widely adopted learned intermediary doctrine, a drug manufacturer, for example, is […]

| 3 min read
KW
Former Partner

Product Recall Trends in 2015

What are the latest trends on product recalls in the United States? Stericycle ExpertSOLUTIONS writes an interesting and informative quarterly report on this data, and its detail on the first quarter of 2015 is here. Consumer Products. The Consumer Product Safety Commission has been proactive in recent years with consumer product regulations and recalls, particularly […]

| 2 min read
KW
Former Partner

The Learned Intermediary Defense Advances in Nevada

The learned intermediary doctrine can be a legal defense against product liability claims. It is most commonly applied in cases involving drugs and medical devices.  A learned intermediary is a medical expert, such as a prescribing physician, who can weigh the risks and benefits of a medication and make informed prescription decisions based on knowledge […]

| 3 min read

FDA Issues Draft Guidance on Distributing New Risk Information for Approved Drugs and Biologics

In June 2014, the U.S. Food and Drug Administration (FDA) issued a draft guidance for the distribution of new risk information for approved prescription drugs to healthcare professionals and healthcare entities. The draft guidance, entitled Guidance for Industry Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices, establishes […]

| 4 min read

Drug and Device Manufacturers Beware: Comments Could Result in FDA Troubles

After appearing on CNBC television show Fast Money, the CEO of Aegerion Pharmaceuticals received a warning letter from the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion.  The agency asserted that comments made on the show constituted promotional speech and resulted in Aegerion’s cholesterol lowering drug, Juxtapid, being misbranded. According to […]

| 2 min read
LW
Former Proposals Specialist

Product Recall Trends and How to Prepare for a Recall

Product recalls are more common than ever.  We see recall announcements virtually every week.  Consumers have come to expect them, and to expect that companies will act quickly and decisively when a product risk is identified. Most recalls today are voluntary and move very rapidly.  Here are some observations about 2013 recall trends. Pharmaceutical/Drug.  Pharmaceutical […]

| 4 min read
KW
Former Partner