Author Archives: Paul L. Knobbe

FDA Issues Draft Guidance on Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions

The U.S. Food and Drug Administration (FDA) recently released a draft guidance document with the intent of providing clarity for FDA staff and the medical device industry regarding the benefit and risk factors the FDA may consider when prioritizing resources for compliance and enforcement efforts to maximize medical device quality and patient safety. These risk-benefit factors may be considered when device manufacturers evaluate appropriate responses to non-conforming product or regulatory compliance issues, including voluntary recall or market withdrawal, and apply to both diagnostic and therapeutic…

Continue Reading....

New FDA Labeling Changes to Require “Black Box Warning” on Immediate Release Opioid Pain Medications

In an effort to combat what it calls “epidemic levels of opioid addiction and overdose”, the U.S. Food and Drug Administration (FDA) announced that it will require class-wide safety labeling changes for immediate release opioid pain medications, including a new “black box warning” informing patients and prescribers of the serious risks of misuse, abuse, addiction, overdose and death. In addition, the FDA will also require several safety labeling changes across all prescription opioid products to include additional warnings addressing the risks of opioids. Opioid analgesics,…

Continue Reading....

California Court of Appeals Rules Plaintiffs Can Pursue Claims Against Novartis for Alleged Damages Arising From Ingestion of Generic Drug Six Years After Novartis Divested its Interest

On March 9, 2016, the California Court of Appeals ruled that the plaintiffs’ claims of failure to warn and misrepresentation against Novartis were legally viable. The critical dispute raised by Novartis was that it did not manufacture the prescription medication that allegedly harmed the plaintiffs. In T. H. v. Novartis Pharms. Corp., No. D067839, 2016 Cal. App. LEXIS 179 (Ct. App. Mar. 9, 2016), two minor plaintiffs alleged that Novartis was liable for neurological injuries they sustained in utero after their mother was prescribed,…

Continue Reading....

FDA Issues Guidance for Applying Human Factors and Usability Engineering to Medical Devices to Ensure Safety and Effectiveness

In an effort to assist the medical device industry in maximizing the likelihood that new medical devices will be safe and effective for intended users, the U.S. Food and Drug Administration recently released Guidance for Industry and FDA Staff on Applying Human Factors and Usability Engineering in Medical Devices. While this FDA guidance document does not establish legally enforceable responsibilities for manufacturers, it is the FDA’s intent to support manufacturers in improving the design of medical devices to minimize potential use errors and resulting…

Continue Reading....

FDA Draft Guidance for Postmarket Management of Cybersecurity in Medical Devices Puts Manufacturers on Notice of Potential Cybersecurity Risks

This post also appears on Goldberg Segalla’s Product Liability Playbook blog.  On January 22, 2016, citing cybersecurity threats to medical devices as a growing concern, the United States Food and Drug Administration issued draft guidance for industry and FDA administration staff for postmarket management of cybersecurity in medical devices. Public comments on the draft guidance will be open for 90 days. According to the FDA release, a growing number of medical devices are designed to be networked to improve and facilitate patient care. However, the…

Continue Reading....