News and Blog

On August 3, 2026, the California Supreme Court issued its decision in the Gilead Tenofovir Cases, rejecting a novel negligence theory that would have significantly expanded potential liability for pharmaceutical manufacturers. The ruling reverses a California Court of Appeal decision that had recognized what many have described as a "duty to innovate," a theory that would have permitted plaintiffs to pursue negligence claims based not on defects in an existing product, but rather on allegations that a manufacturer delayed bringing a safer alternative product to market.

One of the greatest challenges in Parkinson's disease is that diagnosis often occurs after significant neurological changes have already taken place. Researchers now believe the disease may begin years—or even decades—before the motor symptoms that typically trigger clinical evaluation. By the time symptoms appear, most patients have lost 60% to 80% or more of the dopamine-producing cells in the substantia nigra. This growing understanding has intensified the search for reliable biomarkers that could improve diagnosis, monitor disease progression, guide clinical trial recruitment, and support the development of new therapies.

The element helium is often associated with party balloons and novelty uses. However, the shortage of high-grade helium following the commencement of hostilities in the Middle East on February 28, 2026, presents a significant and underappreciated risk for the life sciences sector. The conflict has created a potentially long-lasting impact on the cost and availability of medicinal products and critical inputs such as helium, which is essential for the operation of certain medical devices.

In a recent post on this blog, we examined the U.S. Food and Drug Administration's (FDA) core regulatory framework for artificial intelligence (AI) and machine learning (ML) enabled medical devices — the Predetermined Change Control Plan (PCCP), the clinical decision support boundary question, cybersecurity mandates, and what the framework means for company legal and regulatory teams. This article examines converging obligations that extend beyond that foundation.

Digital health is rapidly reshaping how healthcare is delivered, expanding access while introducing new clinical, regulatory, and liability risks. Technologies such as digital therapeutics (DTx) and telehealth platforms are at the forefront of this transformation, enabling more personalized, scalable, and data-driven care models.

At the same time, these innovations place increasing responsibility on companies operating in the space. As more of the patient experience moves to digital platforms, maintaining trust becomes central to how these technologies are adopted and scaled.

This year, as the nation celebrates the 250th anniversary of the American Revolution, the U.S. Food and Drug Administration (“FDA”) is engaged in a revolution of its own: a broad-based effort to forge an alternative pathway for new medical products to reach the public in an expedited fashion.

Spanish explorer Ponce de Leon’s “fountain of youth” is legendary. In St. Augustine, Florida, visitors still flock to a tourist attraction named for that mystical spring, hoping that a drink from the city’s natural waters might turn back their biological clocks.

At least the only consequence of indulging in the Ponce de Leon fantasy is a mouthful of sulfur‑smelling water. Today’s pursuit of the “fountain of youth” carries greater risk. Increasing numbers of consumers are injecting themselves with unapproved peptides based on unsubstantiated claims that these compounds bestow regenerative properties. Many of these products are purchased from online sellers operating outside traditional regulatory oversight, where they have not been tested for either efficacy or safety.

The pharmaceutical industry is in the middle of a meaningful shift in research strategy. For many years, research teams pursued blockbuster drugs—compounds designed to treat common conditions shared by large segments of the population. Novel treatments for high blood pressure, diabetes, elevated cholesterol, and other widespread ailments were the gold standard.

In a recent post on this blog, we examined how artificial intelligence (AI) and machine learning (ML) are reshaping the informed consent process in clinical trials—and why the regulatory and legal frameworks surrounding AI in that context are still catching up. That article focused on one corner of the clinical trial lifecycle. This one broadens the lens. Medical devices, and in particular software as a medical device (SaMD) is a different but related category.

In a recent episode of HBO Max’s The Pitt, an emergency-room attending physician shows medical students the time savings that can come from using a generative artificial intelligence (AI) tool to listen to a doctor–patient conversation and populate a medical record in seconds. But the same storyline highlights the downside: the tool invents details, confuses medications, and even swaps “neurology” for “urology”—mistakes that could put a patient at risk.