Federal Preemption Claims: Clear Evidence and an Unclear Standard
- Last week, a federal court in Utah granted Aventis Inc.’s motion for summary judgment based on federal preemption of failure-to-warn claims. Cerveny v. Aventis, Inc. , 2016 U.S. Dist. LEXIS 34182 (D. Utah Mar. 16, 2016). The court found that the FDA’s rejection of... ›
Internet of Things: Whose Data Is It Anyway?
The Internet of Things (IoT) is booming. Smart cars, wearable health trackers, connected medical devices, drones—entrepreneurs and evolving industry are connecting to the world in ways only science fiction writers imagined. In 2008, the number of connected devices surpassed the number of people on... ›FDA Embraces Internet of Things: New Draft Guidance on Postmarket Cybersecurity for Medical Devices
By: Erin M. Bosman and Julie Y. Park
The FDA’s recently issued draft guidance on “ Postmarket Management of Cybersecurity in Medical Devices ” seeks to address some of the increasing concerns that medical device providers, regulators, and consumers have about postmarket cybersecurity standards related to medical devices. Because the consequences of... ›Liability for Brand Drug Manufacturers All But Clear
By: Erin M. Bosman and Julie Y. Park
Earlier this month, a federal district court in Illinois denied GlaxoSmithKline’s (GSK) renewed summary judgment motion based on federal preemption of failure-to-warn claims in an opinion setting tough standards for brand drug manufacturers. Judge Zagel found that GSK had not shown “clear evidence” that... ›Defendants Find Relief from Burdensome Discovery Requests
By: Erin M. Bosman, Julie Y. Park and Brittany Scheinok
Litigation often involves lengthy battles over the proper scope of discovery. Defendants with substantial resources frequently find themselves on the receiving end of unreasonable discovery requests in an attempt to overwhelm the party and stall litigation. A recent district court decision in In re... ›FAA Announces Drone Registration, but Legal Challenges Loom
Note: In light of the FAA’s announcement of the drone registry, we’ve revisited our recent analysis of its authority to require registration.] On December 14, 2015, the FAA issued the much-anticipated “Registration and Marking Requirements for Small Unmanned Aircraft Interim Final Rule” (the “Interim... ›New Settlement Highlights FDA’s Diminishing Power Over Off-Label Promotion
By: Erin M. Bosman, Julie Y. Park and Brittany Scheinok
In a surprising turn of events, Pacira Pharmaceuticals, Inc. and the Food and Drug Administration (FDA) announced that they have settled their dispute regarding the off-label promotion of Exparel, one of Pacira’s anesthetic drugs. This settlement represents the latest marker of the FDA’s diminishing... ›Sixth Circuit Sweeps State-Law Design Defect Claims Under the Rug of Impossibility Preemption
By: Erin M. Bosman and Julie Y. Park
Last week, the Sixth Circuit Court of Appeals issued a groundbreaking opinion in Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc. that could change the liability landscape for brand-name drug manufacturers. No. 15-3104 (6th Cir. Dec. 11, 2015). Yates is the first federal appellate authority to recognize... ›Consumer Products “Either/Or”: California Issues Guidance on Alternatives Analysis for Safer Products
By: William F. Tarantino
California’s Green Chemistry Initiative has taken another step forward with the issuance of guidance on the heart of the law, the analysis of safer substitutes for chemicals in consumer products. On September 24, 2015, the California Department of Toxic Substances Control (DTSC) released its... ›Pay Attention to the Man Behind the Curtain: DOJ Memorandum Adds Further Weight to CPSC Enforcement Efforts Against Corporate Officers
By: Erin M. Bosman and Julie Y. Park
The United States Department of Justice (DOJ) recently issued a memorandum to various enforcement agencies. The memorandum, available here , focuses on holding individuals accountable for corporate fraud and misconduct. [1] The DOJ has already shown it means business. Just days after the memorandum... ›